Regulatory Affairs Associate

Regulatory Affairs Associate
- Full Time
- Hybrid
- Based in Mumbai or Vadodara - (3 days in the office and two days working from home)

About the Company
Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets. Our mission is to improve patient health globally by revitalising niche, tried-and-trusted medicines. Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers worldwide. Our growth has enabled the company to reinvest in its products, brands, people, and communities.

Today, Pharmanovia employs more than 300 colleagues representing 29 nationalities and operates across Europe, the Middle East, Asia-Pacific, and Latin America. Our core therapeutic areas include Cardiovascular, Oncology, Endocrinology, and Neurology. We are an agile, entrepreneurial, and innovative speciality pharmaceutical company committed to maximising the value of established and speciality medicines while improving patient access worldwide.

About the Role
We are seeking a Regulatory Affairs Associate to join our growing Global Regulatory Affairs team. This is an excellent opportunity for a regulatory professional with experience in product labelling, lifecycle management and global regulatory processes to contribute to a diverse international portfolio. You will support global regulatory activities, product information maintenance, labelling compliance, and regulatory submissions, while collaborating closely with Regulatory Affairs, Pharmacovigilance, Artwork, Supply Chain, and external partners worldwide.

The successful candidate will play a key role in ensuring regulatory compliance, maintaining accurate product information, supporting global labelling strategies and driving timely implementation of regulatory changes across international markets.

Responsibilities
Supporting the development, maintenance and implementation of global product labelling strategies, including CCDS, SmPCs, package inserts and associated patient information documents.
Preparing, reviewing and maintaining global and regional product information documentation to ensure compliance with applicable regulatory requirements.
Managing global labelling updates and lifecycle maintenance activities across multiple international markets.
Reviewing prescribing information, patient information leaflets and product labelling for Europe, North America, Australia and key emerging markets.
Preparing and managing regulatory documentation to support product information variations, updates and submissions.
Acting as a key contributor to Labelling Committee activities, including preparation, review and presentation of supporting documentation.
Maintaining accurate product information records within regulatory information management systems (RIMS) and electronic document management systems (eDMS).
Ensuring timely implementation and communication of approved labelling changes to internal and external stakeholders.
Supporting the preparation, review and quality control of regulatory submission packages and associated documentation.
Reviewing and approving artwork and packaging components to ensure alignment with approved product information.
Working closely with global affiliates, distributors, consultants and health authorities to support regulatory submissions and product maintenance activities.
Monitoring regulatory developments and communicating regulatory risks, requirements and mitigation strategies to project teams and stakeholders.

Qualifications
Bachelor's degree in a scientific, pharmaceutical, healthcare or life sciences discipline.

Required Skills

Experience with in Regulatory Affairs, Regulatory Labelling, Medical Affairs, Pharmacovigilance, Clinical Research or a related pharmaceutical function.
Strong experience supporting global product labelling activities, including CCDS, SmPC updates, package inserts and artwork approval processes.
Good understanding of global regulatory labelling requirements and lifecycle management processes.
Experience maintaining product information and regulatory documentation across international markets.
Knowledge of regulatory submission structures and content, including MAA, NDA and lifecycle maintenance submissions.
Familiarity with EU regulatory requirements, guidelines and regulatory procedures.
Experience working with Regulatory Information Management Systems (RIMS) and electronic document management systems (eDMS).
Ability to review complex regulatory documents for accuracy, consistency and compliance.
Strong scientific and technical writing skills.
Excellent attention to detail with proven ability to identify inconsistencies and mitigate compliance risks.

Preferred Skills
Experience supporting global labelling governance processes.

Experience with product lifecycle management in international markets.
Additional language skills, particularly…