Executive - Regulatory and Scientific Affairs:

Job Responsibilities:

- Regulatory expert responsible for the submissions, RFIs and compliance activities for pharma development and commercial products supporting Business Unit.

- Leads the preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops mitigation plans.

- Provide regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities, for regional products registered specifically for EU/AU/CA/UK markets.

- Acts as the global regulatory representative within cross-functional teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic regulatory decisions.

- Accountable for interactions with regulatory agencies and external partners either directly or in conjunction with other stake holders.//




- Operate independently to resolve issues and manage regulatory risks and ambiguous situations within project teams.

- Investigates opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems. May take appropriate risk to achieve desired results.

- Responsible for review of CMC documents (GMP docs) for drug product and active substance.

- Responsible for review of active substance master file

- Responsible for compilation of CMC dossier (module 2 and module 3) with accuracy for regulated market (EU/AU/CA/UK) product initial registrations.

- Compilation of dossier in CTD/eCTD format.

- Ensure proper dossier writing practice and adhere to global regulatory standards.

- Provide regulatory support to cross functional teams.

📌 Executive - Regulatory Affairs (Ahmedabad)
🏢 Novumgen
📍 Ahmedabad