Regulatory Affairs Manager

Role & responsibilities: :

• Manage regulatory affairs for parenteral dosage forms (preferably contrast media), ensuring compliance with all relevant regulations.
• Prepare and submit regulatory dossiers/documents for the targeted markets
• Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals)
• Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines
• Act as liaison between multiple project teams to obtain significant information as well as answer queries that may arise
• Stay up to date with the latest rules and regulations.
• Assist in preparing response to regulatory authority's questions within assigned timelines.
• Stay abreast of regulatory procedures and changes in regulatory climate.
• Coordinate and document internal regulatory processes, including inspections, internal audits, license renewals, and registrations.
• Support cross-functional teams in product development and commercialization efforts.
• Ensure compilation of a quality dossier or responses to regulatory authorities in coordination with research and development team and manufacturing plants
• Build and maintain strong relationships with health agencies and regulatory bodies.
• Manage the product lifecycle for global markets, ensuring timely submissions and updates.
• Coordinate with local country partners/distributors to ensure a quality submission.

Preferred candidate profile: :

• Experience in enabling approvals in shortest possible time, post-marketing surveillance and product lifecycle management.
• Familiarity with global regulatory trends and updates.
• Strong organizational skills and attention to detail.

Perks and benefits