- The purpose of the Affiliate Regulatory Affairs role is to manage the operational and technical aspects of regulatory affairs for the marketing affiliate, including:
- Execute the Regulatory Plan to ensure the success of new product registration, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and
- quality system requirements.
- Foster an setting of operational excellence and collaborate with cross-functional teams to successfully achieve Affiliate regulatory objectives.
- Facilitate and cultivate relationships with the local regulatory agency/MoH.
Primary Responsibilities:
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional
responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Regulatory Plan Execution
Implement the Regulatory Plan in alignment with affiliate business plans as well as regulatory requirements.
Ensure submission and approval of high quality regulatory applications within planned timelines. Maintain or support maintenance of clear metrics for Regulatory deliverables.
- Preparation and support of new applications to obtain marketing authorisations.
- Voicing affiliate perspective and needs to global and regional regulatory contacts.
- Ensuring timely responses to requests from support groups and/or Regulatory Authorities.
- Maintaining marketing authorisations (timely submission of post approval maintenance activities like renewals, variations and periodic reports)
- Maintain Regulatory Tools in alignment with defined compliance metrics.
- Support Affiliate launch Teams anticipating potential regulatory constraints and delivering regulatory outcomes