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Novumgen looking for Regulatory Affairs Associate Executive, Sr. Executive


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Novumgen looking for Regulatory Affairs Associate Executive

Novumgen was founded by a group of experienced pharmaceutical professionals with the goal of developing and producing innovative, high quality medicines. The company quickly established itself as a leader in the UK market, and soon began licensing its products in other countries around the world.

Post : Executive / Sr. Executive - RA

Work Location : Vadodara

Job Description
• Regulatory expert responsible for the submissions, RFIs and compliance activities for pharma development and commercial products supporting Business Unit.
• Leads the preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops mitigation plans.
• Provide regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities, for regional products registered specifically for EU/AU/CA/UK markets.
• Acts as the global regulatory representative within cross-functional teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic regulatory decisions.
• Accountable for interactions with regulatory agencies and external partners either directly or in conjunction with other stake holders.
• Operate independently to resolve issues and manage regulatory risks and ambiguous situations within project teams.
• Investigates opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems. May take appropriate risk to achieve desired results.

Interested candidates can share their CV on

Last Date : 30th April 2024

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