- Oversee the preparation, submission, and management of regulatory dossiers, including eCTD submissions, for sterile formulations inclusive of drug-device combination products across international markets.
- Ensure continuous compliance with global regulatory requirements (ROW Market) throughout the product lifecycle.
- Conduct regulatory impact assessments and risk evaluations to anticipate and mitigate potential compliance issues.
- Work closely with R&D;, Quality Assurance, Manufacturing, and Marketing teams to support product development and commercialization strategies.
- Review and approve labelling, promotional materials, and other regulatory documents to ensure accuracy and compliance with regulatory standards.
- Stay updated on evolving global regulatory requirements and provide strategic guidance on regulatory changes that may impact products.
Prepare for and support regulatory inspections and audits, ensuring
readiness and compliance during regulatory authority reviews.
Required Experience, Qualification and Skills
- M.Sc. / M Pharma with 10+yrs of proven experience in regulatory affairs, with a focus on sterile formulations..
- Robust understanding of global regulatory requirements, particularly ROW markets
- Proficiency in eCTD submission platforms and electronic regulatory filing systems.
- Experience with regulatory submissions for medical devices, biologics, or pharmaceuticals.
- Excellent written and verbal communication abilities, with attention to detail.