Senior Regulatory Affairs Role

Key Responsibilities:

- Lead the development and preparation of product registration submissions, progress reports, supplements, amendments, and periodic experience reports.

- Act as the primary liaison with regulatory agencies to expedite approval of pending registrations and maintain compliance throughout the product lifecycle.

- Provide regulatory guidance during product planning and implementation, regulatory strategy development, risk management, and chemistry manufacturing control (CMC) activities.

- Ensure timely approval of new drugs, biologics, or medical devices, as well as continued approval of marketed products.

- Represent the regulatory function in cross-functional teams, including marketing, research, and technical groups.

- Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, and regulatory requirements.

- Interpret and apply regulatory guidelines to business and product decisions, ensuring alignment with organizational and compliance goals