Pharmanovia, a fast-growing global specialty pharmaceutical company, is hiring a Regulatory Affairs Associate for its Global Regulatory Affairs team. The position is available in Mumbai and Vadodara, India, with a hybrid work model requiring three days in the office and two days working from home.
This is an excellent opportunity for professionals with experience in regulatory affairs, regulatory labelling, pharmacovigilance, medical affairs, or clinical research to work on global pharmaceutical products across more than 140 international markets. The role focuses on product labelling, lifecycle management, regulatory submissions, and compliance activities.
About Pharmanovia
Pharmanovia is an international pharmaceutical company with a portfolio of more than 20 brands operating in over 140 countries. The company specializes in revitalizing niche and established medicines across therapeutic areas including:
- Cardiovascular
- Oncology
- Endocrinology
- Neurology
The organization employs over 300 professionals representing 29 nationalities and has operations across Europe, Asia-Pacific, the Middle East, and Latin America.
Job Details
- Position: Regulatory Affairs Associate
- Company: Pharmanovia
- Job Type: Full-Time
- Work Mode: Hybrid (3 days office, 2 days remote)
- Location: Mumbai, Maharashtra, India / Vadodara, Gujarat, India
- Industry: Pharmaceuticals and Regulatory Affairs
Key Responsibilities
The Regulatory Affairs Associate will be responsible for:
- Supporting global product labelling strategies including CCDS, SmPCs, package inserts, and patient information leaflets.
- Maintaining and updating global and regional product information documentation.
- Managing product lifecycle maintenance activities across international markets.
- Reviewing prescribing information and product labels for Europe, North America, Australia, and emerging markets.
- Preparing regulatory documentation for product variations and submissions.
- Supporting Labelling Committee activities and documentation reviews.
- Maintaining records in Regulatory Information Management Systems (RIMS) and electronic document management systems (eDMS).
- Communicating approved labelling changes to internal and external stakeholders.
- Supporting preparation and quality review of regulatory submission packages.
- Reviewing artwork and packaging components to ensure regulatory compliance.
- Collaborating with affiliates, distributors, consultants, and health authorities worldwide.
- Monitoring global regulatory developments and assessing regulatory risks.
Qualifications Required
Candidates should possess:
- Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Healthcare, Pharmacy, or a related scientific discipline.
Required Skills
- Experience in Regulatory Affairs, Regulatory Labelling, Medical Affairs, Pharmacovigilance, Clinical Research, or related pharmaceutical functions.
- Knowledge of global product labelling requirements and lifecycle management.
- Experience with CCDS, SmPC updates, package inserts, and artwork approval processes.
- Understanding of regulatory submissions, including MAA, NDA, and lifecycle maintenance submissions.
- Familiarity with EU regulatory procedures and guidelines.
- Experience using RIMS and eDMS platforms.
- Strong scientific writing and document review skills.
- Excellent attention to detail and compliance management capabilities.
Preferred Qualifications
- Experience supporting global labelling governance processes.
- Experience in international product lifecycle management.
- Additional language skills such as German, Italian, or French.
- Previous experience in multinational pharmaceutical organizations or specialty pharmaceutical companies.
Salary and Benefits
Estimated Salary Range: ₹8,00,000 – ₹14,00,000 per annum (depending on experience and qualifications).
Benefits include:
- Competitive salary package
- Annual performance bonus
- Hybrid working model
- Paid holidays and leave benefits
- Employee recognition programs
- Social and team engagement events
- Pension and retirement benefits
- Global career development opportunities
Why Consider This Regulatory Affairs Job?
This Pharmanovia Regulatory Affairs Associate position provides exposure to:
- Global regulatory affairs operations
- International product labelling projects
- Regulatory submissions across multiple regions
- Cross-functional collaboration with pharmacovigilance, artwork, and supply chain teams
- Career growth within a multinational pharmaceutical organization
How to Apply
