Regulatory Affairs Professional: Improving Patient Health

3 days ago


Mumbai, Maharashtra, India Lifelancer Full time
About the Role

As a key member of our Regulatory Affairs team, you will provide strategic and operational support to project management on new divestment projects, technical transfer, CMOs, quality assurance, and commercial departments.

Your expertise in regulatory submission structure and content, artwork requirements, and review in line with regulations will be essential in preparing core dossiers and submissions for global rollouts. You will collaborate with global partners, consultancies, and distributors to outline global regulatory intelligence and form a global regulatory strategy.

We are looking for a highly skilled and experienced professional with a strong understanding of the EU regulatory framework and guidelines. Your ability to effectively communicate with regulatory authorities, present complex regulatory strategies, and maintain product life cycle databases and RIMs systems will be invaluable to our team.

About Us

Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT. Our dynamic team comprises over 300 employees from 29 nationalities, operating from offices worldwide.

We offer a competitive salary plus bonus and rewards package, including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme, and hybrid working.

This role presents an exciting opportunity to join our agile and innovative global specialty pharma business, instigating a paradigm shift in the life cycle management of iconic medicines. As a Regulatory Affairs Manager, you will contribute to delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world.

Responsibilities and Duties
  • Providing strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance, and commercial departments
  • Preparing core dossiers and submissions for global rollouts
  • Collaborating with global partners, consultancies, and distributors to outline global regulatory intelligence and form a global regulatory strategy
  • Maintaining product life cycle databases and RIMs systems
  • Effectively communicating with regulatory authorities
  • Presenting complex regulatory strategies
Requirements

We seek a candidate with at least 5 years of regulatory generalist experience within a pharmaceutical company, CRO, CMO, or similar organisation. Your qualifications should include:

  • Bachelor's degree in science/health discipline
  • Excellent IT skills, including MS Word, Excel, Project, PowerPoint, and Outlook
  • Strong knowledge of EU regulatory framework and guidelines
  • Experience in compliance and maintaining product life cycle databases and RIMs systems
  • Ability to effectively communicate with regulatory authorities
  • Awareness of emerging markets submission rollouts

Estimated Salary: ₹1200000 - ₹1800000 per annum



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