Regulatory Affairs Associate

About the company

Pharmanovia is an international pharmaceutical business that is expanding quickly and manages a portfolio of more than 20 brands in over 140 markets. The organisation focuses on improving patient outcomes by giving new life to established, niche medicines. Founded in 2013, the company has shown steady year-on-year growth by delivering quality branded prescription products to patients, prescribers, and healthcare professionals around the world. That growth has helped fund continued investment in its medicines, brands, people, and communities. Pharmanovia now has over 300 employees from 29 nationalities and operates across Europe, the Middle East, Asia-Pacific, and Latin America. Its main therapeutic areas include cardiovascular, oncology, endocrinology, and neurology. The company describes itself as agile, entrepreneurial, and innovative, with a strong focus on increasing the value and availability of established and specialty medicines worldwide.

Role overview

This position is for a Regulatory Affairs Associate to join the Global Regulatory Affairs team. The role is suited to a regulatory professional with hands-on exposure to product labelling, lifecycle management, and international regulatory procedures. The selected candidate will assist with global regulatory work, product information upkeep, labelling compliance, and submission activities, while coordinating with Regulatory Affairs, Pharmacovigilance, Artwork, Supply Chain, and outside partners across different regions. The role is important for keeping product information accurate, supporting worldwide labelling approaches, and helping regulatory changes go live on time across global markets. This is a hybrid position based in Mumbai or Vadodara, with three days in the office and two days working from home.

Responsibilities

• Help create, maintain, and roll out global product labelling strategies, covering CCDS, SmPCs, package inserts, and related patient information materials.
• Draft, check, and update global and regional product information so it remains aligned with the relevant regulatory rules.
• Handle labelling updates and ongoing lifecycle maintenance across several international markets.
• Review prescribing information, patient leaflets, and product labels for Europe, North America, Australia, and important emerging markets.
• Prepare and manage regulatory documents needed for product information variations, revisions, and submissions.
• Contribute actively to Labelling Committee work, including preparing, reviewing, and presenting supporting materials.
• Keep product information records accurate in RIMS and eDMS platforms.
• Make sure approved labelling changes are communicated and implemented on time with internal teams and external stakeholders.
• Support the preparation, review, and quality checks of regulatory submission packs and related documents.
• Review and approve artwork and packaging elements to ensure they match approved product information.
• Work with global affiliates, distributors, consultants, and health authorities on regulatory filings and product maintenance tasks.
• Track regulatory changes and share potential risks, requirements, and mitigation plans with project teams and stakeholders.

Requirements

• A bachelor’s degree in a scientific, pharmaceutical, healthcare, or life sciences subject.
• Professional experience in Regulatory Affairs, Regulatory Labelling, Medical Affairs, Pharmacovigilance, Clinical Research, or another related pharmaceutical area.
• Strong practical experience with global product labelling, including CCDS, SmPC updates, package inserts, and artwork approval workflows.
• Working knowledge of global labelling rules and product lifecycle management processes.
• Experience handling product information and regulatory records across multiple countries or regions.
• Understanding of regulatory submission formats and content, including MAA, NDA, and lifecycle maintenance filings.
• Familiarity with EU regulatory requirements, guidelines, and procedures.
• Experience using Regulatory Information Management Systems (RIMS) and electronic Document Management Systems (eDMS).
• Ability to examine detailed regulatory documents for accuracy, consistency, and compliance.
• Strong scientific and technical writing ability.
• Sharp attention to detail and the ability to spot inconsistencies and reduce compliance risk.
• Preferred: exposure to global labelling governance, product lifecycle management in international markets, additional language skills such as German, Italian, or French, and experience in specialty pharmaceuticals, branded medicines, or multinational pharma companies.

Perks and compensation

• Competitive salary with bonus and rewards package.
• Holiday entitlement.
• Employee recognition awards.
• Social events.
• Pension scheme.
• Hybrid working arrangement.

Equal opportunity

Pharmanovia states that it is an equal opportunity employer and does not unlawfully discriminate on the basis of race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, or any other legally protected status. This applies to all aspects of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Reasonable accommodations will be provided for qualified individuals with known disabilities in line with applicable law.