Senior Manager - Regulatory Affairs - New Pharma Products

Industry - Pharma / Biotech / Clinical Research

Category - Operations

Skills - Regulatory Affairs

Job Type - Permanent

Description:

 - RA management- registration and delivery for new product pipeline

- Regulatory strategy planning, analysis of risk, procedure management, reporting and delivery of projects

Client Details : A global pharma MNC

Job Description : 

- Provision of support for new product evaluation to BD&L Team

- Preparation of Regulatory submission strategy

- Submitting regulatory applications for new products

- Communicating with the authorities for facilitating the new product submissions

- Responding to regulatory queries, proposing improvement strategies for new products

Profile :

- Candidate must have at least 8 years of RA experience with specific focus on New Product Launches

- Europe market exposure is a must

- Degree in a scientific discipline

- Familiarity with NCE Filing, Hybrid submissions required. Centralised procedure experience is a must

- Strong communication skills and presentation skills are a must

Job Offer:

- Opportunity to work with growth oriented Pharma MNC

- Manage Regulatory Affairs for new products

- Be a part of a lean team that gives direct exposure to working with the Executive level

- Agile working policy

To apply online please click the 'Apply' button below.

For a confidential discussion about this role please contact Srividya Mukunthan on +91 22 4236 3304.

Contact - Srividya Mukunthan - +91 22 4236 3304

The Apply Button will redirect you to website. Please apply there as well.