Manager Regulatory Affairs API

Manager Regulatory Affairs API Job in Hyderabad – Biophore India

Biophore India is hiring a Manager Regulatory Affairs API for its Hyderabad, Telangana facility. This pharmaceutical industry opportunity is suitable for professionals with 10 to 15 years of experience in API regulatory affairs, global dossier submissions, DMF preparation, regulatory compliance, and lifecycle management activities. Candidates with an M.Pharm qualification can apply for this full-time position. The selected candidate will lead regulatory strategies, manage submissions across global markets, and ensure compliance with international regulatory requirements while supporting business growth and product registrations.

Location

Hyderabad, Telangana, India

Employment Type

Full-time

Experience Required

10 to 15 Years

Educational Qualification

M.Pharm

Key Responsibilities

• Lead API regulatory affairs activities for global markets.
• Prepare and review DMFs, CEPs, and regulatory dossiers.
• Coordinate submissions with international regulatory agencies.
• Manage regulatory lifecycle activities and variations.
• Review technical and quality documentation.
• Track changing regulatory requirements.
• Support customer regulatory queries.
• Coordinate with R&D, QA, QC, and manufacturing teams.
• Lead regulatory audits and inspections.
• Ensure timely submission and approval of regulatory filings.

Required Skills & Competencies

• Strong API regulatory affairs expertise.
• Knowledge of global regulatory guidelines.
• DMF and CEP preparation experience.
• Regulatory submission management skills.
• Leadership and team management abilities.
• Excellent communication skills.
• Analytical and problem-solving capabilities.
• Project management expertise.
• Attention to detail.
• Cross-functional coordination skills.

Why Join Biophore India?

• Leadership opportunity in global regulatory affairs.
• Exposure to international pharmaceutical markets.
• Career advancement opportunities.
• Innovative and growth-oriented environment.
• Professional development and learning culture.