Regulatory affairs

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.

He, she participates in all activities relating to preparation, submission and follow up to obtain approvals, renewals for products and its variations and line extension indications and labeling approvals of medical devices of various business units of Medtronic. He, she will be responsible for providing technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures

Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions. Co-ordination with clients for the tracking and status update of project plans.

Author Safety Data Sheets for multiple geographies across the globe as per applicable hazard communication regulations. Derive hazard classifications for substances and mixtures using various classification regulations including but not limited to GHS, CLP, and OSHA Hazard Communication Standard.

HPLC, GC method development for OSD & API having exposure to regulated, Semi Regulated and India markets including Complex generic, F2F, Topical and Dermaceuticals, Peptides, Oncology.

Biochemical analysis such as protein content, sodium metabisulphite testing, HPLC, and sample management include receiving in-process samples, final bulk and final lot samples, distribution, and storage under appropriate storage conditions.

Regulatory Submissions Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations. API Equipment Handling.