Executive - Regulatory Affairs

Novumgen; Ahmedabad District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Novumgen is seeking an Executive in Regulatory and Scientific Affairs in India (Ahmedabad region). The role covers submissions, RFIs, and regulatory compliance for pharma development and commercial products across EU/AU/CA/UK markets.

You will lead CMC information preparation, assess risks, and drive regulatory strategies while collaborating with global teams to ensure compliant CTD/eCTD dossiers.

Responsibilities

• Regulatory expert responsible for submissions, RFIs and compliance activities for pharma development and commercial products.
• 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 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.
• 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.

Job description

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.