Regulatory Specialist

Regulatory Project Coordinator/Manager

Key Responsibilities:

I. Documentation & Legal Coordination

• Central Document Management:

  Coordinate the preparation, notarization, and Apostillization of essential legal and administrative documents, including Power of Attorneys (POAs), Letters of Authorization (LOAs), Good Manufacturing Practice (GMP) Certificates, Certificates of Pharmaceutical Product (CoPP), and Free Sale Certificates (FSC).

• Technical Documentation:

  Collaborate with the Regulatory Affairs (RA) team to compile, organize, and get technical documents (e.g., Qualitative & Quantitative (Q&Q) data) apostilled.

• Dispatch Management:

  Manage the timely preparation and dispatch of all hard-copy documents and samples to country-based regulatory teams.

II. Cross-Functional Project Management

• HO & Country Team Liaison:

  Serve as the primary liaison between the HO functional teams (Legal, SCM, IT, IP, Portfolio, R&D) and country regulatory teams to facilitate support and resolve queries efficiently.

• Supply Chain & Sample Coordination:

  Coordinate with Plant QC/QA to arrange Finished Product (FP) samples and Analytical Pre-Requisites for dossier submissions. Prepare Proforma Invoices and necessary declarations for sample shipments.

• IP & Portfolio Support:

  Coordinate with IP teams on patent-related aspects and with Portfolio teams on Product Evaluation Form (PEF) and Product Information File (PIF) requirements.

• R&D Collaboration:

  Coordinate with the R&D Project Management team on DPDM (Drug Product Development Management) and CDP (Clinical Development Plan) analysis.

III. Compliance, Due Diligence & Market Support

• Communication:

  Conduct regular weekly and monthly calls with country and Indian RA teams to review progress, track dossier deliveries, and address regulatory issues.

• Due Diligence:

  Perform due diligence with QC labs and R&D teams to ensure compliance with country Ministry of Health (MOH) requirements, specifically ensuring working standard qualification and stability data maintenance.

• Market Support:

  Arrange back-end regulatory support for Business Development (BD) and Marketing teams, including securing supportive documents for tender participation in Emerging Markets.

• Logistics:

  Coordinate with logistics teams for the effective dispatch of all regulatory shipments.

• Planning:

  Actively participate in the New Dossier Planning process with Regulatory teams.

• Experience:

  Proven experience 5-6 years in Regulatory Affairs, Regulatory Operations, or Project Management within the Pharmaceutical industry, preferably with exposure to Emerging Markets.

• Regulatory Knowledge:

  Strong understanding of the documentation and submission process for
  international product registration/dossiers.