Regulatory Affairs Lead
2 days ago
We are seeking an experienced Regulatory Affairs professional to join our team as a Regulatory Affairs Lead in Pharmaceutical Product Development.
About the Role:
- Provide strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
- Lead the preparation of core dossiers and submissions for global roll out, ensuring compliance with regulatory requirements.
- Autoring, reviewing and approving M3 dossier sections as necessary, justification documents and Product Information.
- In collaboration with global partners, consultancies and distributors, outline global regulatory intelligence and form a global regulatory strategy.
- Develop and review global cross-functional regulatory strategies, working closely with senior management and project strategy teams.
- Negotiate and make agreements on behalf of the department, ensuring timely and accurate submissions.
About You:
Candidates with at least 5 years of regulatory generalist experience within a pharmaceutical company, CRO, CMO, or similar organisation, are likely to have the skills required to be successful in this role. We are also looking for:
- Bachelor's degree in science/health discipline
- Expertise in regulatory submission structure and content
- Strong knowledge of EU regulatory framework and guidelines
- Experience in compliance and maintaining product life cycle databases
- Ability to effectively communicate with regulatory authorities
- Fluent English language (written and verbal)
What we offer:
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. Estimated salary: ₹1,200,000 - ₹1,800,000 per annum. Based on location and experience, this could vary accordingly.
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