Assistant Regulatory Affairs Manager

2 weeks ago

Ahmedabad, Gujarat, India Octavius Pharma Full time ₹ 4,20,000 - ₹ 8,40,000 per year

Role & responsibilities

  • To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all LATAM, MENA, CIS and ROW Countries and other country as per company requirements.
  • Responsible for final review of dossier before submission.
  • To coordinate with technical team for documents required for dossier.
  • Responsible to gather data related for dossier through online sources, laboratories, manufactures, etc.
  • Reviewing artwork for products as per relevant regulatory authority requirements.
  • To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements;
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness.
  • Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives.

Preferred candidate profile

Qualification: B. Pharm and M. Pharm

Experience: Minimum 5 years in ROW market for Formulation Dossier preparation and submission

Perks and benefits

Salary: 40,000 to 70,000 per month

Mediclaim

Bonus

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