International Regulatory Affairs Lead

4 days ago


Navi Mumbai, Maharashtra, India Domnic Lewis International Full time

We are seeking a highly skilled International Regulatory Affairs Lead to join our team at Domnic Lewis International. This role offers an excellent opportunity for a career-minded professional to take on new challenges and contribute to the success of our organization.

About the Role:

The International Regulatory Affairs Lead will be responsible for ensuring compliance with regulatory standards, preparing and reviewing CTD and ACTD dossiers, coordinating with plant and R&D teams, and managing renewals. This position requires strong analytical and communication skills, as well as experience with eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, and MCC South Africa for Biological and Biotech products.

Key Responsibilities:

  1. Prepare and review CTD and ACTD dossiers to ensure compliance with regulatory requirements.
  2. Coordinate with Plant and R&D teams to gather inputs necessary for regulatory submission.
  3. Ensure plant compliance with regulatory standards.
  4. Manage renewals and update Master data.
  5. Conduct regular follow-ups with the plant for documentation and review meetings.
  6. Track and review document requirements for upcoming new filings in ROW and Emerging markets.

Requirements:

  • 7+ years of experience in regulatory affairs, with a focus on biosimilars or biologic products.
  • M. Pharm or B. Pharm degree.
  • Excellent analytical and communication skills.
  • Experience with eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, and MCC South Africa for Biological and Biotech products.

What We Offer:

We offer a competitive salary of $120,000 - $150,000 per annum, depending on experience, plus a range of benefits including health insurance, retirement plan, and paid time off. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.



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