Biocon Limited is an Indian biopharmaceutical company based in Bangalore, India.[2] The Company manufactures generic active pharmaceutical ingredients (APIs) that are sold in the developed markets of the United States and Europe. It also manufactures biosimilar insulins, which are sold in India as branded formulations and in both bulk and formulation forms. In research services, Syngene International Limited (Syngene) is engaged in the business of custom research in drug discovery
Job Title :Â Asst. Manager/ Dy. Manager Regulatory Affairs Generic Formulations
Experience : 4-8 years
Location : Bangalore
Job Description:
- Write high quality deficiency response to various regulatory authorities including the USA, Europe and Health Canada for Solid oral and Injectable products.
- Compilation (eCTD format) & review of dossier (ANDA, MAA, ANDS) including technical data package.
- Review of Batch records, specification, art work, and packaging material, analytical method validation documents, development documents, PDR and labeling.
- Coordination with R&D in evaluating and finalizing the QbD elements at different stages of product development.
- Knowledge of commercial regulatory requirements for all the regulated markets.
- Compilation (eCTD format) & review of dossier (ANDA, MAA, ANDS) including technical data package for Solid oral and Injectable products.
- Review of Batch records, specification, art work, and packaging material, analytical method validation documents, development documents, PDR and labeling.
- Coordination with R&D in evaluating and finalizing the QbD elements at different stages of product development.
- Write high quality deficiency response to various regulatory authorities.
- Knowledge of commercial regulatory requirements for all the regulated markets.
- In depth knowledge of QbD requirements.
- In depth knowledge of USFDA, EU, Health Canada & ICH guidelines, and the regulatory requirements of various International Regulatory Agencies.
- In depth knowledge of post approval and commercial regulatory activities.
- Effective team management skills.
Desired Profile:
- UG: B.Sc – Any Specialization, B.Pharma – Pharmacy
- PG:MS/M.Sc(Science) – Any Specialization, M.Pharma – Pharmacy
