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30/03 Neelam Dogra
Senior Consultant at Synergy Consultants

Views:149 Applications:15 Rec. Actions:Recruiter Actions:2

Manager/Senior Manager - Regulatory Affairs - Pharma (5-14 yrs)

Delhi NCR Job Code: 1071273

Purpose:

- The purpose of the Affiliate Regulatory Affairs role is to manage the operational and technical aspects of regulatory affairs for the marketing affiliate, including:

- Execute the Regulatory Plan to ensure the success of new product registration, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements.

- Foster an environment of operational excellence and collaborate with cross-functional teams to successfully achieve Affiliate regulatory objectives.

- Facilitate and cultivate relationships with the local regulatory agency/MoH

Education & Experience

i) B.Pharm, M. Pharm, BSc or Master's Degree in Chemistry or Biotechnology or related areas, or MD (licensed in the country, if applicable, according to local regulations).

ii) Minimum 5 years of regulatory affairs or related experience

iii) In-depth knowledge of local regulations pertaining to product registration requirements for pharmaceutical products and devices and understand its interpretation as well as Regulatory Corporate policies

iv) Have or acquire overall understanding of the local business decision-making process that impacts the regulatory strategy.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Women-friendly workplace:

Maternity and Paternity Benefits

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