Carry out Regulatory submission processes and Pharmacovigilance case processing within agreed timelines.
Responsible for dossier preparation, review and compilation of documents required for submission of MA application in India.
Responsible for dossiers compilation, preparation of briefing package for scientific advisory meetings and submission of BE NOC application, CDSCO NOCs, import permission, registration of products and/or sites in India.
Responsible for applying Test license, Manufacturing license, Additional Product Licenses and Loan licenses, GMP, GLP, COPP, FSCs, Non-convection certificate, EU WC, WHO GMP etc.
Gap analysis and risk assessment for the submission based on the available data/documents and appraise team on change in regulatory guidance.
Preparation of application and Co-ordinate with CROs and CMOs for on time submission of application.
Support new product development with special attention to fit- for-purpose regulatory requirements.
Review and approve protocols, reports, validation plans, development report, DMFs, art works and other CMC documents etc.
Ensure handling, compiling and responding queries to regulatory authorities.
Ensure preparation of quality dossier and co-ordinate with internal stake holder for submission of application.
Ensure regulatory compliance as per regulatory requirement and global policy.
Required Education/Qualifications/Skills M. Pharm with at least 5 years of industrial experience, in the field of regulatory affairs for India and other markets.
Ferring India FHPDC R&D
Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine and maternal health, and in areas of gastroenterology and urology. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which markets its medicines in over 100 countries.
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