Senior Manager - Regulatory Affairs

Lusynco · India

Brookes Pharma is seeking an experienced and dynamic Senior Manager – Regulatory Affairs to lead regulatory strategies and ensure compliance with local and international regulatory requirements.

Qualifications & Experience

• Education: Pharm-D from a recognized institution
• Experience: 10–12 years of relevant regulatory affairs experience in the pharmaceutical industry
• Strategy & Compliance: Expertise in developing and implementing regulatory strategies for local and export markets
• Dossier Preparation: Hands‑on experience preparing and submitting regulatory dossiers to local and international authorities
• Global Standards: Strong knowledge of global regulatory requirements and market‑specific compliance
• Audits & Inspections: Proven experience in regulatory inspections, audits, and compliance management
• Leadership & Skills: Ability to provide guidance to cross‑functional teams, monitor evolving requirements, and demonstrate excellent communication and stakeholder management skills