Senior Regulatory Affairs Manager / Regulatory Affairs Lead – 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 an experienced Senior Regulatory Affairs Manager / Regulatory Affairs Lead to join our Global Regulatory Affairs team. This is a highly visible strategic role responsible for leading global regulatory activities across product acquisitions, divestments, marketing authorisation applications (MAAs), marketing authorisation transfers (MATs), lifecycle management programmes and new product development initiatives. You will act as a key regulatory leader across cross-functional project teams, partnering closely with Commercial, Quality, Supply Chain, Medical Affairs, Pharmacovigilance, Technical Operations, CMOs and external partners to drive successful global regulatory outcomes. The successful candidate will combine deep regulatory expertise with strong leadership, project management and stakeholder engagement skills, helping shape regulatory strategy and support Pharmanovia’s continued global growth.
Responsibilities
- Leading the development and execution of global regulatory strategies for new product acquisitions, divestments, licensing opportunities, marketing authorisation applications (MAAs), marketing authorisation transfers (MATs) and lifecycle management activities.
- Driving global MAA rollout programmes, ensuring regulatory strategies support commercial objectives and timely market access across international territories.
- Leading and coordinating global Marketing Authorisation Transfer (MAT) activities across multiple regions and health authorities.
- Acting as the regulatory lead for strategic projects involving technical transfers, product acquisitions, divestments, CMOs, supply chain changes and quality-related initiatives.
- Providing strategic regulatory guidance to senior leadership and cross-functional project teams throughout the product lifecycle.
- Developing, reviewing and approving regulatory dossiers, including Module 3 documentation, Product Information, scientific justifications and supporting regulatory documentation.
- Defining global submission strategies and regulatory pathways for both established and newly acquired products.
- Leading interactions with global health authorities, distributors, regulatory consultancies and business partners to support regulatory approvals and compliance.
- Representing Regulatory Affairs in due diligence activities, business development projects and portfolio expansion initiatives.
- Interpreting evolving global regulatory requirements and translating them into practical business strategies and risk mitigation plans.
- Coordinating and managing complex regulatory submissions across multiple international markets and territories.
- Monitoring submission progress, regulatory milestones and project timelines to ensure successful delivery against business objectives.
- Serving as the primary regulatory contact for internal stakeholders, external partners and regulatory agencies.
- Leading regulatory agency meetings, health authority interactions and regulatory negotiations where required.
- Providing strategic regulatory intelligence on emerging regulations, market developments and changing regulatory landscapes.
- Maintaining oversight of regulatory compliance activities and ensuring adherence to applicable global regulatory requirements.
- Managing regulatory lifecycle activities including variations, renewals, product information updates and post-approval commitments.
- Ensuring accurate maintenance of regulatory information within RIMS and document management systems.
Qualifications
- Bachelor’s degree in Pharmacy, Life Sciences, Pharmaceutical Sciences, Chemistry, Biology, Medicine or a related scientific discipline.
- 10+ years of broad Regulatory Affairs experience within a pharmaceutical company, biotechnology organisation, CRO, CMO or related healthcare environment.
Required Skills
- Strong experience acting as a regulatory generalist across multiple regulatory disciplines and product lifecycle activities.
- Extensive experience leading global Marketing Authorisation Applications (MAAs), Marketing Authorisation Transfers (MATs) and lifecycle management programmes.
- Deep understanding of EU regulatory frameworks, procedures and pharmaceutical legislation.
- Strong experience supporting global regulatory rollout strategies across multiple international markets.
- Demonstrated expertise in regulatory submission structure, content development and dossier management.
- Experience leading regulatory strategy for product acquisitions, divestments, licensing transactions and technical transfer projects.
- Proven ability to independently develop, communicate and defend complex global regulatory strategies.
- Experience engaging directly with regulatory authorities and successfully managing health authority interactions.
- Strong knowledge of regulatory compliance requirements, lifecycle management processes and regulatory governance.
- Experience working with Regulatory Information Management Systems (RIMS) and electronic document management systems.
- Expertise in scientific writing, technical documentation and regulatory dossier preparation.
Pay range and compensation Package
We offer a competitive salary plus a bonus and rewards package, including holidays, employee recognition awards, social events, a pension scheme, and hybrid Working
Equal Opportunity Statement
Pharmanovia is an equal-opportunity employer. Pharmanovia does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Pharmanovia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
