Specialist, Regulatory Affairs ( Fixed Term 6 months)

Job Description

Responsibilities

• Drive product registration plans and strategies and work cross-functionally to review and communicate the registration strategy with management oversight.

• Timely preparation, submission of post-market regulatory dossiers including but not limited to variations, renewal applications and supplemental marketing authorization in accordance with local regulations and global standards including support GAIA projects under responsible Phuchayhaa Therapeutic area.

• Coordinate with POHO team for archiving and maintenance of regulatory data and documentation in accordance with department and company policies and local requirements

• Coordinate with artwork team (Flyer) to develop artwork and responsible to check and comply as local HA approval.

• Work collaboration with supply to communicate and participant supply meeting (if ...