Assistant/Deputy Manager-Regulatory Affairs(Europe Mkt-Formulations)

Aizant

7 - 10 years

0 Lacs

hyderabad

Posted:3 days ago| Platform:

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Skills Required

europe market cft ctd dossier preparation regulatory affairs dossier regulatory compliance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Dear All,

Regulatory Affairs Assistant Manager/Deputy Manager

Key Responsibilities:

Prepare, compile, and submit high-quality regulatory dossiers in compliance with EU and UK market requirements.
Collaborate with cross-functional teams (CFTs) to ensure alignment with regulatory standards and timely compliance
Maintain accurate and up-to-date regulatory documentation and manage regulatory databases effectively.
Demonstrate strong communication skills to engage with internal teams and external regulatory authorities.
Possess in-depth knowledge of EU regulatory guidance, procedures, and submission pathways
Understand and manage post-approval variation requirements specific to EU & UK markets.
Good knowledge on review of quality documents
Address regulatory queries promptly and ensure timely submission of required responses.
Monitor evolving regulatory requirements and communicate relevant updates to internal stakeholders

raghuveera.vutla@aizant.com

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