CrawlJobs Logo

Sr Associate Regulatory Affairs

amgen.com Logo

Amgen

Location Icon

Location:
South Korea , Seoul

Category Icon
Category:
-

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products. The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.

Job Responsibility:

  • Assist in aligning local regulatory requirements with Amgen’s corporate standards
  • Provide national/regional input to and execute regulatory strategies
  • Plan and manage local regulatory submissions
  • Ensure local labels are developed and maintained
  • Act as the point of contact with regulatory agencies
  • Plan and manage clinical trial applications through CRO
  • Manage CRO work invoice and participate in global network
  • Work as a point of contact and oversight for Global Regulatory Affairs & Strategy
  • Contributes for the filing plan
  • Executes the filing plan
  • Ensures regulatory submissions are made on time
  • Creates, reviews and approves source text for country labeling
  • Collaborates with Regional and Global Study Operations teams
  • Reviews and approves the promotional and non-promotional materials
  • Monitors changes in the national legislation
  • Monitors the external regulatory environment
  • Ensures/supports regulatory product compliance
  • Acts as the point of contact with regulatory agencies
  • Participates/contributes to local agency interactions
  • Works closely with cross-functional colleagues
  • Exchanges regulatory information and intelligence with other regulatory colleagues
  • Partners with International Regulatory Leads
  • Partners with peers to ensure consistency on procedures
  • Acts as contact and create relationships with Agency staff
  • Assists locally in Healthcare Compliance activities
  • Participates in local regulatory process improvements, initiatives and training
  • Oversees external vendor/contractor relationships

Requirements:

  • At least 5 years of directly related experience
  • Business-level proficiency in Korean and English is required
  • Knowledge of Regulatory principles
  • Working with policies, procedures and SOP’s
  • Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
  • Understanding of drug development
  • Under general supervision interact with local health and regulatory authorities for routine matters
  • Demonstrate ability to work in teams
  • Ability to understand and communicate scientific/clinical information

Nice to have:

  • Depth knowledge of country(ies) legislation and regulations relating to medicinal products
  • Experience in plan/submit/approval of New drug application
  • Experience in clinical trial application and negotiation with MFDS

Additional Information:

Job Posted:
March 01, 2026

Work Type:
Hybrid work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Sr Associate Regulatory Affairs

Senior Director Regulatory Affairs

The Senior Director of Regulatory Affairs is responsible for assuring that all d...
Location
Location
United States , Washington, DC
Salary
Salary:
137846.78 - 241870.90 USD / Year
adtalem.com Logo
Adtalem Global Education
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree required, Master's Degree preferred
  • Minimum 10 years experience in a heavily regulated environment
  • preferably within post-secondary education required
  • Title IV compliance experience preferred
  • At least 5 years of supervisory experience
  • Must be familiar with the standards and requirements of the U.S. Department of Education, multiple state authorizing agencies and programmatic accreditors
  • Must possess strong critical thinking skills to decipher regulatory requirements that may not be explicit
  • Demonstrated ability to establish and develop positive relationships with senior leaders and external agencies
  • Strong interpersonal, organizational, writing, editing, and computer skills are required
  • Strong understanding of federal Title IV regulations
Job Responsibility
Job Responsibility
  • Leads and motivates the Regulatory Research, Compliance Review, Regulatory Strategy and Reporting teams of Regulatory Affairs colleagues
  • Collaborates with institution and business leaders, as well as peers in Regulatory Affairs, Internal Audit and Legal, to drive continual process and quality improvement
  • Monitors operations in all departments/functions to ensure compliance with federal and state/provincial higher education-related laws and regulations and organizational and divisional policies
  • Establishes working relationships with operating managers to assess the viability of their compliance functions, and educate operating units as to the essential components of a strong compliance program
  • Coordinates the compilation and synthesis of reporting for the quarterly Regulatory Compliance and Quality Assurance reviews with each of the institutions
  • Recommends business practice changes to improve compliance with higher education laws and regulations
  • Ensures that corrections in the areas of non-compliance are made timely and accurately
  • In coordination with the appropriate organization managers, reviews proposed process changes (including system requirements) to ensure they are in compliance with higher education-related federal and state/provincial laws and regulations and corporate and divisional requirements
  • Immediately reports areas of concern to the VP, Sr. Associate General Counsel and develops correction action plans and appropriate training requirements
  • Utilizing both internal and external resources, supports efforts to influence federal and state regulation development
What we offer
What we offer
  • Health, dental, vision, life and disability insurance
  • 401k Retirement Program + 6% employer match
  • Participation in Adtalem’s Flexible Time Off (FTO) Policy
  • 12 Paid Holidays
  • Eligible to participate in an annual incentive program
  • Fulltime
Read More
Arrow Right

Senior Director Regulatory Affairs

The Senior Director of Regulatory Affairs is responsible for assuring that all d...
Location
Location
United States , Columbia
Salary
Salary:
137846.78 - 241870.90 USD / Year
adtalem.com Logo
Adtalem Global Education
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree required, Master's Degree preferred
  • Minimum 10 years experience in a heavily regulated environment
  • preferably within post-secondary education required
  • Title IV compliance experience preferred
  • At least 5 years of supervisory experience
  • Must be familiar with the standards and requirements of the U.S. Department of Education, multiple state authorizing agencies and programmatic accreditors
  • Must possess strong critical thinking skills to decipher regulatory requirements that may not be explicit
  • Demonstrated ability to establish and develop positive relationships with senior leaders and external agencies
  • Strong interpersonal, organizational, writing, editing, and computer skills are required
  • Strong understanding of federal Title IV regulations
Job Responsibility
Job Responsibility
  • Leads and motivates the Regulatory Research, Compliance Review, Regulatory Strategy and Reporting teams of Regulatory Affairs colleagues, achieving strategic and compliance objectives of the organization
  • Collaborates with institution and business leaders, as well as peers in Regulatory Affairs, Internal Audit and Legal, to drive continual process and quality improvement
  • Monitors operations in all departments/functions to ensure compliance with federal and state/provincial higher education-related laws and regulations and organizational and divisional policies
  • Establishes working relationships with operating managers to assess the viability of their compliance functions, and educate operating units as to the essential components of a strong compliance program
  • Coordinates the compilation and synthesis of reporting for the quarterly Regulatory Compliance and Quality Assurance reviews with each of the institutions
  • Recommends business practice changes to improve compliance with higher education laws and regulations
  • Ensures that corrections in the areas of non-compliance are made timely and accurately
  • In coordination with the appropriate organization managers, reviews proposed process changes (including system requirements) to ensure they are in compliance with higher education-related federal and state/provincial laws and regulations and corporate and divisional requirements in the areas of academics, career services, enrollment management, state and provincial licensing, student finance, and student services
  • Immediately reports areas of concern to the VP, Sr. Associate General Counsel and develops correction action plans and appropriate training requirements
  • Utilizing both internal and external resources, supports efforts to influence federal and state regulation development. Serves as a resource for Adtalem’s Government Relations team on legislative matters related to institutions of higher education
What we offer
What we offer
  • Health, dental, vision, life and disability insurance
  • 401k Retirement Program + 6% employer match
  • Participation in Adtalem’s Flexible Time Off (FTO) Policy
  • 12 Paid Holidays
  • Eligible to participate in an annual incentive program
  • Fulltime
Read More
Arrow Right

Senior Director Regulatory Affairs

The Senior Director of Regulatory Affairs is responsible for assuring that all d...
Location
Location
United States , Minneapolis
Salary
Salary:
137846.78 - 241870.90 USD / Year
adtalem.com Logo
Adtalem Global Education
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree required, Master's Degree preferred
  • Minimum 10 years experience in a heavily regulated environment
  • preferably within post-secondary education required
  • Title IV compliance experience preferred
  • At least 5 years of supervisory experience
  • Must be familiar with the standards and requirements of the U.S. Department of Education, multiple state authorizing agencies and programmatic accreditors
  • Must possess strong critical thinking skills to decipher regulatory requirements that may not be explicit
  • Demonstrated ability to establish and develop positive relationships with senior leaders and external agencies
  • Strong interpersonal, organizational, writing, editing, and computer skills are required
  • Strong understanding of federal Title IV regulations.
Job Responsibility
Job Responsibility
  • Leads and motivates the Regulatory Research, Compliance Review, Regulatory Strategy and Reporting teams of Regulatory Affairs colleagues, achieving strategic and compliance objectives of the organization
  • Collaborates with institution and business leaders, as well as peers in Regulatory Affairs, Internal Audit and Legal, to drive continual process and quality improvement
  • Monitors operations in all departments/functions to ensure compliance with federal and state/provincial higher education-related laws and regulations and organizational and divisional policies
  • Establishes working relationships with operating managers to assess the viability of their compliance functions, and educate operating units as to the essential components of a strong compliance program
  • Coordinates the compilation and synthesis of reporting for the quarterly Regulatory Compliance and Quality Assurance reviews with each of the institutions
  • Recommends business practice changes to improve compliance with higher education laws and regulations
  • Ensures that corrections in the areas of non-compliance are made timely and accurately
  • In coordination with the appropriate organization managers, reviews proposed process changes to ensure they are in compliance with higher education-related federal and state/provincial laws and regulations and corporate and divisional requirements
  • Immediately reports areas of concern to the VP, Sr. Associate General Counsel and develops correction action plans and appropriate training requirements
  • Utilizing both internal and external resources, supports efforts to influence federal and state regulation development
What we offer
What we offer
  • Health, dental, vision, life and disability insurance
  • 401k Retirement Program + 6% employer match
  • Participation in Adtalem’s Flexible Time Off (FTO) Policy
  • 12 Paid Holidays
  • Eligible to participate in an annual incentive program
  • Fulltime
Read More
Arrow Right

Senior Director Regulatory Affairs

The Senior Director of Regulatory Affairs is responsible for assuring that all d...
Location
Location
United States , Chicago
Salary
Salary:
137846.78 - 241870.90 USD / Year
adtalem.com Logo
Adtalem Global Education
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree required, Master's Degree preferred
  • Minimum 10 years experience in a heavily regulated environment
  • preferably within post-secondary education required
  • Title IV compliance experience preferred
  • At least 5 years of supervisory experience
  • Must be familiar with the standards and requirements of the U.S. Department of Education, multiple state authorizing agencies and programmatic accreditors
  • Must possess strong critical thinking skills to decipher regulatory requirements that may not be explicit
  • Demonstrated ability to establish and develop positive relationships with senior leaders and external agencies
  • Strong interpersonal, organizational, writing, editing, and computer skills are required
  • Strong understanding of federal Title IV regulations
Job Responsibility
Job Responsibility
  • Leads and motivates the Regulatory Research, Compliance Review, Regulatory Strategy and Reporting teams of Regulatory Affairs colleagues, achieving strategic and compliance objectives of the organization
  • Collaborates with institution and business leaders, as well as peers in Regulatory Affairs, Internal Audit and Legal, to drive continual process and quality improvement
  • Monitors operations in all departments/functions to ensure compliance with federal and state/provincial higher education-related laws and regulations and organizational and divisional policies
  • Establishes working relationships with operating managers to assess the viability of their compliance functions, and educate operating units as to the essential components of a strong compliance program
  • Coordinates the compilation and synthesis of reporting for the quarterly Regulatory Compliance and Quality Assurance reviews with each of the institutions
  • Recommends business practice changes to improve compliance with higher education laws and regulations
  • Ensures that corrections in the areas of non-compliance are made timely and accurately
  • In coordination with the appropriate organization managers, reviews proposed process changes (including system requirements) to ensure they are in compliance with higher education-related federal and state/provincial laws and regulations and corporate and divisional requirements in the areas of academics, career services, enrollment management, state and provincial licensing, student finance, and student services
  • Immediately reports areas of concern to the VP, Sr. Associate General Counsel and develops correction action plans and appropriate training requirements
  • Utilizing both internal and external resources, supports efforts to influence federal and state regulation development. Serves as a resource for Adtalem’s Government Relations team on legislative matters related to institutions of higher education
What we offer
What we offer
  • Health, dental, vision, life and disability insurance
  • 401k Retirement Program + 6% employer match
  • Participation in Adtalem’s Flexible Time Off (FTO) Policy
  • 12 Paid Holidays
  • Eligible to participate in an annual incentive program
  • Fulltime
Read More
Arrow Right

Sr. Manager - Government & External Affairs

The Sr. Manager, Government Affairs at T-Mobile is responsible for helping lead ...
Location
Location
United States , Remote - Use Home Address, Various, California
Salary
Salary:
119700.00 - 215900.00 USD / Year
https://www.t-mobile.com Logo
T-Mobile
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in public policy, Political Science, Law, Communications, or related field
  • Masters Preferred
  • 5-10 years’ experience in government affairs, public policy, strategic alliances, or legislative advocacy, preferably within the telecommunications or technology industries
  • Strong understanding of federal, state, and local government processes and regulations affecting telecommunications
  • 5+ years building and maintaining relationships with key government officials and demonstrated ability to influence public policy outcomes
  • Strategic Thinking: Ability to develop and implement effective strategies that align with the company's business goals and regulatory environment
  • Relationship Management: Capability to build and maintain strong relationships with government officials, regulatory bodies, and third-party organizations
  • Collaboration: Ability to work collaboratively in a fast-paced, dynamic environment
  • Strategic Planning: Proficiency in planning long-term strategies that incorporate public policy trends and regulatory changes
  • Leadership: Strong leadership skills to guide and influence both internal teams and external stakeholders
Job Responsibility
Job Responsibility
  • With emphasis in California, develop and implement comprehensive government affairs strategies to support T-Mobile’s business goals and policy priorities
  • Represent T-Mobile before non-profit organizations, legislators, regulators, and other governmental officials at all levels
  • Advocate for policies that promote innovation, competition, and consumer benefits in the wireless sector
  • Build coalitions with industry partners, think tanks, trade associations, and community organizations to amplify T-Mobile’s voice
  • Coordinate with internal teams, including Legal, Compliance, and Public Relations, to ensure unified messaging and strategy
What we offer
What we offer
  • Competitive base salary and compensation package
  • Annual stock grant
  • Employee stock purchase plan
  • 401(k)
  • Access to free, year-round money coaches
  • Medical, dental and vision insurance
  • Flexible spending account
  • Paid time off and up to 12 paid holidays
  • Paid parental and family leave
  • Family building benefits
  • Fulltime
Read More
Arrow Right

Accountant Senior - Investments

Performs complex accounting processes, creates budgets and pro formas for design...
Location
Location
United States , Tucson
Salary
Salary:
Not provided
tmcaz.com Logo
Tucson Medical Center
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Accounting or Finance
  • Four (4) - six (6) years years accounting, investment analysis and/or auditing experience
  • Ability to create, interpret, and work with financial data
  • Ability to define problems, draw valid conclusions, and present resolution
  • Knowledge of and ability to improve processes and policy
  • Display advanced skills including organizing tasks, providing written and verbal communication, researching records and reports, use of computer applications and systems to include: Word, EXCEL, Outlook and accounting software
Job Responsibility
Job Responsibility
  • Performs complex accounting processes, creates budgets and pro formas
  • Responsible for analyzing and reporting the organizations investments with portfolio in accordance with GAAP, regulatory requirements and internal policy
  • Responsible for accurate accounting for investment transactions, supports financial audits and collaborate with Treasury and other finance teams as well as the external investment managers
  • Evaluates processes and provides recommendations regarding internal control or process efficiency
  • Understands complex accounting issues and can make recommendations regarding correct Generally Accepted Accounting Principles (GAAP) treatment
  • Analyzes business operations and provides consultation for optimum system utilization
  • Sr. Accounting Analyst will assist also be responsible for other accounting related activities and responsibilities in month-end close
  • Works effectively with all levels within the organization
  • acts as a liaison with staff to assess their needs and provide information and support as needed
  • Advise and support team members to set priorities and utilize problem-solving techniques
  • Fulltime
Read More
Arrow Right
New

Healthcare Assistant & Lead Healthcare Assistant

Are you passionate about supporting older people and making a meaningful differe...
Location
Location
Ireland , Cork
Salary
Salary:
Not provided
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in elderly care is desirable but not essential (training may be provided)
  • QQI Level 5 in Healthcare Support or equivalent is an advantage
  • A caring, patient and respectful approach to supporting older people
  • Ability to work flexible shifts including days, nights, and weekends
  • Strong commitment to resident safety, dignity and wellbeing
  • Applicants must have legal entitlement to work in Ireland
Job Responsibility
Job Responsibility
  • Deliver person-centred care to residents with dignity and respect
  • Support residents with activities of daily living where required
  • Encourage independence and social engagement
  • Maintain a clean, safe and comfortable living environment
  • Build positive relationships with residents, families, and colleagues
  • Follow all health, safety and safeguarding procedures
  • Assist with compliance processes, inspections, and quality standards
  • Lead Healthcare Assistants will also assist in guiding care teams, supporting best practice, and helping maintain high standards of care delivery
What we offer
What we offer
  • Flexible working hours to support work–life balance
  • Local employment opportunities within the Douglas, Cork area
  • Competitive rates of pay in line with experience and role
  • Supportive team environment with ongoing training and development
  • Employee wellbeing initiatives
  • Uniform provided
  • Free on-site parking
  • Meals provided while on duty
Read More
Arrow Right
New

Bakery Team Member

Join us to "Change Hospitality For Good". Here at the Cornish Bakery, we want to...
Location
Location
United Kingdom , Falmouth
Salary
Salary:
8.05 - 12.80 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Eligible to live and work in the UK
Job Responsibility
Job Responsibility
  • Make the World’s Best Coffee
  • Deliver Outstanding Customer Service
  • Prepare Award Winning Food
  • Maintain High standards within the Bakery
  • Be part of a Team who strive to Aim Higher at all times
What we offer
What we offer
  • 50% discount on food and drink
  • Pasty Perks – bespoke reward system offering discounts and savings on favourite brands
  • Financial well-being benefit through Stream – save directly from wages into a high interest savings account or access wages before pay-day
  • Employer funded health and wellbeing services with access to a 24/7 GP line, Employee Assistance Program and discounted gym memberships
  • Paid birthday day off
  • Member of the shareholder fund (service dependent)
  • Team social events with in-bakery incentives
  • Up to 28 days of holiday (including bank holidays), pro rata if necessary
Read More
Arrow Right