Specialist-Regulatory Affairs CMC

Clinchoice

4 - 8 years

3 - 7 Lacs

bengaluru

Posted:13 hours ago| Platform:

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Skills Required

emea regulatory affairs cmc life cycle management module 3 drug regulatory affairs regulatory compliance management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Primary Responsibilities:

Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval.
Responsible for writing CMC modules 2 & 3.
Exposure to EU & CIS region in Regulatory filings
Manage and coordinate product life cycle management.
Ensure regulatory compliance with local regulatory requirements.
Foster and maintain professional relationships with the health authorities.
Provide regulatory support including timely registration of new product and line extensions to support new product launches, tender application, and whenever necessary.
Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
Promote regulatory intelligence in both local and regional initiatives.
Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
Responsible for reviewing CMC modules.
Execution of regulatory strategies (local and regional) in line with business plan.
Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
Ensure to adherence to timelines and quality set parameters.
Review of Formulation, generation of ingredient list and Claims as per set standards.

Qualification

Minimum B.S. Chemistry, Pharmacy or related scientific field
Experience in CMC regulatory affairs for pharmaceutical products.
Experience in Module 3, Module 2.3 and relevant Module 1 e-CTD documentation

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