Regulatory affairs

Experience in regulatory strategy, dossier review, and submission for the US, EU, and Brazil markets. This role requires a deep understanding of CMC requirements and the ability to lead the regulatory strategy for various dosage forms, including complex injectables and ophthalmic products.

Preparation of regulatory monitor and market intelligence data. Analyse and share market intelligence data and preparation of regulatory monitor capturing key regulatory developments on monthly basis.

Preparation and submission of post approval variations and send proper communication for implementation of the change. Co-ordination with GRA, Country regulatory affiliates and COE for submission of dossier and supporting the required documentations.

Post graduate degree in Pharmacology or Regulatory science or a related field. Proven track record of collaborating with government bodies, academic institutions, and industry stakeholders

Sets up product development and registration objectives in aligment with RA Sub-Region Head, RA MOW Head New Product Planning, Regional Commercial team objectives and in close partnership with the local LT. Master in Life Sciences degree. PhD or Higher Degree or equivalent experience desirable

Customer Questionnaire filling and submission with supporting documentation set. Basic knowledge of Company and Product registration into international countries like Europe, Indonesia, Brazil, GCC countries etc.

direct recruitment of Faculty on a regular basis through open competition; Ph. D. with first class or equivalent grade at the preceding degree in the appropriate branch, a very good academic record throughout, and Teaching/ Research/ Industrial experience with published work of high quality. Well- recognized and established reputation for having made a conspicuous seminal contribution to knowledge in pharmaceutical and allied areas. 

interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. Lead submission for annual reports, facility registrations, facility renewals, and product renewals. Interact with authors, reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions.

Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.