Regulatory Associate Manager - Global Labelling Job at GSK (Bangalore)

Director, Regulatory Labeling

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Pr...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS required
an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors

Job Responsibility

Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
Provide regulatory due diligence as required
Supervise and mentor direct reports

Fulltime

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
Excellent communication, negotiation, and leadership skills
Strong team orientation and passion for continuous self-development

Job Responsibility

Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
Assess and communicate potential regulatory risks and propose mitigation plans
Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
Coordinate and prepare responses to requests for information from regulatory agencies

What we offer

health and retirement, PTO, and stock option plans

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Japan Regulatory Strategy Group Senior Manager

The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regul...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
Communication skills in English (TOEIC score ≥860 desirable)
Native level Japanese
Computers: Microsoft Outlook, Word, Excel, Power Point, and communication tools
Ability to develop and lead effective teams
Ability to work in matrix environments including cross-functional and global teams
Ability to work under minimal direction with a medium degree of autonomy
Analytical skills to evaluate and interpret complex situations and problems
Ability to anticipate and prevent potential problems
Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives

Job Responsibility

Develops and implements the Japan regulatory strategy
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy
Consistently look for opportunities to accelerate the developments/approval
Contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads or oversees the preparation of regulatory submissions
Ensures that regulatory submissions are made on time and meet requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies
Ensures that local labels are developed and maintained
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks

Fulltime

Business Performance Senior Manager

The Business Performance Senior Manager is a member of the Transformation Execut...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree (scientific area) and 10 years of directly related experience OR Bachelor’s degree (scientific area) and 12 years of directly related experience
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
General knowledge of national legislation and regulations relating to medicinal products
General awareness of the registration procedures/challenges in the region for CTAs, MAs and all lifecycle management activities
Knowledge and experience in the international regulatory environment relevant for product area and development stage
Understanding of drug development
Able to anticipate regulatory Agency questions and potential responses
Demonstrate strong teamwork ability

Job Responsibility

Represent GRAAS at cross-functional MAL and Business Development-related forums, providing strategic input and thought leadership
Form and lead sub-function teams for integration and licensing activities, ensuring alignment with strategic objectives
Drive strategic solutions to complex business problems, leading analyses and negotiations with key decision makers
Lead Regulatory workstreams across all deal phases
Serve as Lead for all product licensing work, including integrations into and transitions out of Amgen
Closely partner with Regulatory Affairs (RA) Therapeutic Area Integration Project Lead and advise/instruct them on end-to-end process and details of planning and execution of acquisition integration
Act as their delegate as needed in cross-functional meetings
Assist with pre-deal close GRAAS due diligence
Develop and manage GRAAS integration workplan
Draft and manage any new controlled documents unique to the integration, such as Quality Integration PLANs and bridging process GDEs

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Global Regulatory Affairs Lead, Wellbeing Collective

Lead global regulatory strategy for a fast-growing health supplement business (W...

Location

United States , Hoboken

Salary:

227700.00 - 569250.00 USD / Year

Unilever

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Science (e.g., Pharmacy/Pharm D, Biology, Chemistry) or a higher degree (Ph.D.)
A specialized degree in Regulatory Affairs is highly desirable
Minimum 10+ years of progressive experience in Regulatory Affairs within the Consumer Healthcare or Nutraceutical industry
Demonstrated success in developing and executing regulatory strategies for health products across multiple global regions and different product categories
Proven experience in a global lead regulatory role with a comprehensive understanding of regional regulatory requirements and dynamics across multiple regions (U.S., EU, and/or other international markets)
Strong knowledge of global regulatory requirements and submission formats
Proven experience managing complex regulatory deliverables across product lifecycle stages
Significant experience in interactions with FDA, EMA, and other global regulatory agencies
Deep understanding of the product development process for ingestible health products
Strong sense of urgency and ability to react decisively to regulatory alerts, product challenges, and sustainability trends

Job Responsibility

Build a unified, scalable regulatory capability across a diverse portfolio of acquired businesses and international organization
Develop and Champion Strategy: Define and execute the comprehensive, long-term regulatory strategy for Wellbeing portfolio globally, ensuring alignment with commercial goals
Drive Innovation Pipeline: Serve as the regulatory lead in the global innovation process, providing scientific and regulatory input for new product development, and market entry, including claims support
Opportunity Identification: Proactively monitor regulatory trends and intelligence to identify new product opportunities and potential risks, presenting actionable recommendations to the Wellbeing Collective Operating Companies and International Teams
Set Standards: Set standards and decision-making frameworks for global compliant labeling, claims, and marketing communications. Develop SOPs, define performance metrics, and guide teams on regulatory best practices
International Expansion: Direct and manage regulatory procedures worldwide, including dossier preparation, label development and claims support, and global marketing applications. Provide oversight for preparation and delivery of materials for regulatory agency meetings and inspections
Provides a vision and leadership for Policy and Regulation to assure that appropriate Wellbeing representation in external advocacy activities and industry forums is achieved
Participates in due diligence and provides regulatory advice and perspective on all potential licensing and M&A deals
Brand Portfolio Accountability: Act as the regulatory portfolio owner, ensuring timely and compliant maintenance of the Wellbeing Portfolio
Risk Management: Proactively identify and communicate potential regulatory risks, offering clear mitigation options

What we offer

health insurance (including prescription drug, dental, and vision coverage)
retirement savings benefits
life insurance and disability benefits
parental leave
sick leave
paid vacation and holidays
access to numerous voluntary benefits
bonus eligible
Long-Term Incentive (LTI) eligible

Fulltime

New

Manager - International Regulatory Lead

The International Regulatory Lead (IRL) Manager will provide regulatory leadersh...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR 8 or more years of relevant regional regulatory experience
Master's degree and 9 or more years of relevant regional regulatory experience
Bachelor's degree and 10 or more years of relevant regional regulatory experience
Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes
General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.

Job Responsibility

Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives
Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans)
Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio
Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate
Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing
Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes
Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management
Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams
Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations
Partners with peers to agree on product strategy including projected submission and approval time

New

International Regulatory Lead

The International Regulatory Lead (IRL) Manager will provide regulatory leadersh...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree and atleast 8 years of relevant regional regulatory experience
Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes
General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.

Job Responsibility

Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives
Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans)
Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio
Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate
Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing
Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes
Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management
Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams
Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations
Partners with peers to agree on product strategy including projected submission and approval time

Regulatory Associate Manager - Global Labelling

GSK

Location:
India , Bangalore

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 31, 2026

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