Regulatory Affairs Labeling Executives

3 days ago

Mumbai Maharashtra, India G&L Healthcare Advisors Full time

Contract: Permanent Full-Time

Closing Date: 18/07/25

We are seeking experienced Regulatory Affairs Labeling professionals to join our global regulatory team.

In this role, you will be working in a matrix team of global consultants, with responsibilities for one or more of G&L’s clients. You would be responsible for ensuring accurate and compliant product labelling in accordance with international regulatory requirements.

**Why Join Us?**
- Competitive salary and Benefits package
- Hybrid working model (2 days per week at G&L’s office locations)
- Wide variety of projects, new challenges, and experience
- Start date Q3 & Q4 2025

**The Role**:
**Key Responsibilities**:

- Preparing and reviewing product labels, leaflets, and packaging for compliance with global regulations
- Collaborating with cross-functional teams, including regulatory, medical, and commercial
- Supporting product submissions, updates, and lifecycle management activities
- Maintaining labeling documentation and change control records
- Safety signal assessments, creating and maintaining CCDS
- Experience in providing labelling support across study phases
- Supporting/leading Labeling Working Committee groups/ Labeling Review Committee
- Performing detailed gap analysis of Product Information against regulatory reference products, to determine the highest level of safety information
- Authoring updates using all relevant HA guidelines and the latest templates
- Preparing variation packages
- Undertaking literature reviews
- Post-approval activities

**Requirements**:
**Skills & Competencies**:

- Strong background in regulatory affairs, with specific experience in labeling
- Knowledge of EU, US, and/or global regulatory requirements
- Experience with Document Management Systems
- Working knowledge of Veeva
- Excellent attention to detail and communication skills
- Life sciences degree or equivalent experience
- Strong organizational skills with the ability to manage multiple projects
- Proactive and team-oriented mindset with a commitment to continuous learning
- Excellent working knowledge of MS Office
- Troubleshooting skills
- Flexible and adaptable, with innovative problem-solving abilities
- Expertise in interpreting regulatory requirements and determining compliance strategies

**How to Apply**:
G&L is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.

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