General Manager/Senior General Manager - Regulatory Affairs - Pharma

- The requirement is for a global contract research and manufacturing pharmaceutical organisation (Finished Dosage, Formulations), a leader in its space.

Key Responsibilities :

- To lead and manage the Regulatory Affairs department and ensure Dossiers are delivered to customers as per the agreed requirements.

- To take a lead role in handling different regulatory requirements like EU, Australia, Africa, ROW, Japan, Latin America and Domestic markets and ensure smooth response processing, support services.

- To Develop New markets/Customers and ensure entire dossier process cycle is smoothly handled in coordination with Business Development department.

- Ensure planned Dossier submission is completed as per the Agreed plans

- Ensure Post Approval variation is handled as per EU regulatory Requirements and guidelines.

- To Coordinate with Marketing Services, Manufacturing, QA, QC and Business Development to ensure timely delivery of the dossiers and query responses of the respective markets.

- To play pivotal role of being an Interface between customers and internal departments and guide Individual members of the team to handle respective markets.

- To act as Single window for all customer Regulatory needs, queries, feedback, complaints

- Ensure the regulatory team is given required training on time to time basis with respect to latest updates, regulatory requirement.

Expertise Expected :

- Should have detailed working knowledge of complex worldwide regulatory requirements and demonstrated ability to handle the global internal/external regulatory environment.

- This Position is identified as a Regulatory expert and will mentor teams on the latest developments in this field.

- This position also should possess detailed knowledge of drug development and manufacturing and supply processes.

- Should have demonstrated effective strategies to meet various regulatory/ industry bodies requirements.

- Regulatory Know how - MHRA, TGA, MCC, PMDA, African Countries, ANVISA