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Regulatory Affairs Manager

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Regulatory Affairs Jobs in Ahmedabad

Regulatory Affairs Manager Job Vacancy in Ahmedabad

Hiring for Pharma Regulatory Affairs Executive in Ahmedabad

Position Name - Regulatory Affairs Manager

Total Openings – 2 Male/Female

Location – Thaltej, Ahmedabad

Company info - Healthcare/Medical Pharmaceuticals Company

Salary - up to 45K Monthly

Experience – Min 2 to 3 Years experienced as Regulatory Affairs Officer

Skills & Job Descriptions

- Dossier creation, compilation, review and submission.

- Develop and communicate regulatory strategy for global markets and manage deliverables.

- Responding to deficiency letter and technical queries from regulatory agencies.

- Maintain working knowledge of relevant guidelines to ensure regulatory compliance of major Global markets ie US, Europe, GCC, SEA etc.

- Coordinate with internal departments and timely reminder for arranging documents pertaining to CDSCO applications

- Filling data and submission of proforma of CDEC for form 12 A under Named Patient Drug Supplies.

- To coordinate and maintain record of day to day requirement of technical documents.

- To work on arrangement of Registration samples in accordance with the production and QA departments for Exports Division.

- To coordinate with Clients, Drug Registration Agencies etc for product registration related compliance need &legalization of product registration documents

- Working closely with cross functional teams within the organization and third party teams.

- Maintain good collaboration with all parties for the ongoing projects

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