Regulatory Affairs Manager
For one of our clients, a multinational pharmaceutical company, we are currently looking for a Regulatory Affairs Manager.
- Provide regulatory strategy for the MENA region;
- Works with some independence under limited supervision to provide strategic and operational regulatory direction;
- Lead and coordinate timely and high quality preparation of all necessary supporting documentation by internal or external experts for MENA license renewals, MENA variations (except CMC-related variations), PSUR submissions for assigned registered products;
- Interact with the MENA and other Rest of World Health Authorities to solve regulatory issues related to assigned registered products;
- Represent Regulatory Affairs (RA) in negotiations with HA in MENA;
- Provide prompt and complete responses to regulatory relevant queries from various stakeholders relating to assigned brands;
- Coordinate archiving of submitted registration dossiers and other relevant Health Authority communications;
- Evaluate and review regulatory parts of contracts and CRO quotations.
Qualifications and Experience:
- Degree in life science preferable and at least 6 years experience in regulatory affairs;
- Sound experience with MENA (Middle East and North Africa);
- Ability to work in multicultural environment;
- Excellent communication and interpersonal skills;
- Accuracy and good project management skills;
- Excellent command of spoken and written English;
- Relevant working/residency permit or Swiss/EU-Citizenship required.