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

2 weeks ago

Hyderabad, Telangana, India Aizant Full time ₹ 12,00,000 - ₹ 24,00,000 per year

Dear All,

We are looking for a Regulatory Affairs Assistant Manager/Deputy Manager with 7-10 years of experience in pharmaceutical formulations, specifically for the Europe market.

Key Responsibilities:

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

Interested candidates can share their resumes to