Job Description
The Senior Specialist is responsible for all RA submission requirements and activities for their assigned product portfolio as applicable. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations and is also responsible for other activities delegated by their manager. Acts as a Poison License A Holder for the company.
Responsibilities
- Responsible for execution of local RA processes and activities in alignment with RA systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation.
- Assist in development of product registration plans & strategies and work cross-functionally to review & communicate the strategy with management oversight.
- Assist in timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, and maintenance of authorized products through timely submission of post‑marke...