Regulatory affairs

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.

Ensure the on-time filing of high-quality regulatory submission, and to assist in the preparation, maintenance, and control of regulatory dossiers. Interact with Regulatory agency on regulatory submissions and follow up for drug product approvals.

Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market. Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action. Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions

Candidates with experience in Formulation QA RA, Analytical, Formulation R&D, and interested in advancing their career in RA ROW, are encouraged to apply.