Regulatory Affairs Specialist - French West African Countries
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
As a Regulatory Affairs Specialist you will be covering the French West Africa markets - Morocco, Algeria, Tunisia, Benin, Burkina Faso, Burundi, Cameroon, Central African Republic, Congo (DR), Congo, Djibouti, Gabon, Guinea, Ivory Coast, Mali, Mauritania, Niger, Senegal, Tchad, Togo, other Expanding new French Speaking markets.
In this role, a typical day will include:
- Ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to the local authorities.
- Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
- stays updated on relevant local regulations and guidelines and to develop and maintain positive relationship with key stakeholders in the regulatory environment.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- Maintains a positive relationship with internal and external regulatory contacts.
WHAT YOU'LL BRING TO ALCON:
- Ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, packaging material and other applicable regulatory documents according to our company and local standards and relevant Artwork Management procedures.
- Ensures the correct and proper utilization of Artwork Management System to generate mock-up artwork and to implement revisions to artwork.
- Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
- Ensures that files and archives related to Regulatory are kept updated and complete.
- Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
HOW YOU CAN THRIVE AT ALCON:
- Must hold a degree in pharmacy or other life science or equivalent.
- A minimum of 3 -5 years' experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies.
- The Candidate must be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products & medical devices .
- Experience in French West Africa markets is important for this position.
- Ability to communicate well verbally and in writing in French is essential beside Arabic & English Languages.
- The Candidate should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties.
• Manage your own workload and schedule while hitting your set targets
• Collaborate with teammates to share best practices and learnings as work evolves
• See your career like never before with focused growth and development opportunitiesAlcon Careers
See your impact at alcon.com/careers