FDA Licensing Manager

FDA Licensing Manager Job in Mahad, Raigad – Titan Laboratories Pvt. Ltd.

Titan Laboratories Pvt. Ltd., a reputed pharmaceutical manufacturing company, is hiring an FDA Licensing Manager for its Mahad, Raigad, Maharashtra facility. This opportunity is ideal for experienced regulatory affairs professionals with 10+ years of expertise in pharmaceutical licensing, regulatory compliance, dossier preparation, and authority coordination. Candidates with a B.Sc qualification can apply for this full-time position. The selected candidate will oversee regulatory submissions, manage licensing activities, ensure compliance with applicable regulations, and coordinate with regulatory agencies. This role offers an excellent opportunity to work in a highly regulated pharmaceutical environment while contributing to the company's compliance and business growth objectives.

Location

Mahad, Raigad, Maharashtra, India

Employment Type

Full-time

Experience Required

10+ Years

Educational Qualification

B.Sc.

Key Responsibilities

• Manage pharmaceutical licensing and regulatory activities.
• Prepare and review regulatory submissions.
• Coordinate with FDA and regulatory authorities.
• Ensure compliance with applicable regulations.
• Maintain licensing records and documentation.
• Support product registration activities.
• Monitor regulatory updates and requirements.
• Lead regulatory inspections and audits.
• Coordinate with cross-functional departments.
• Drive continuous compliance improvements.

Required Skills & Competencies

• Strong knowledge of pharmaceutical regulations.
• FDA licensing expertise.
• Regulatory documentation skills.
• Audit management experience.
• Leadership abilities.
• Excellent communication skills.
• Analytical thinking.
• Problem-solving capabilities.
• Attention to detail.
• Project management skills.

Why Join Titan Laboratories Pvt. Ltd.?

• Leadership opportunity in regulatory affairs.
• Exposure to complex licensing projects.
• Career growth in the pharmaceutical sector.
• Professional and compliance-focused environment.
• Long-term development opportunities.