Description
One of our clients, a multinational company in the pharmaceutical industry currently requires a Regulatory Affairs Manager with at least 4 years experience in the pharmaceutical industry
Start: ASAP
Length: 6 months with a possible extension
Location: South of Brussels
FUNCTION DESCRIPTION:
Daily tasks will be related to the regulatory management of products.Role will be to project manage filing of variations worldwide including Europe and resolve supply related issues. It may involve both maintenance of dossiers as well as new dossier submissions. The person will be required to communicate both internally and externally, and maintain and update various databases and planning tools associated with the role.
KEY RESPONSIBILITIES:
The role has the following responsibilities:
- Be responsible for Vaccine Registration activities of one or several projects
- Coordinate, prioritize and plan all the registration activities forthe projects within area of responsibility
- Work to the agreed strategy and actively take steps to ensure thedeadlines are met.
- Identify key issues on registration activities that could preventachieving objectives and pro-actively propose solutions.
- Ensure the plans are updated and communicated appropriately
- Communicate with external regulators on specific enquiries
- Maintain close contacts with the LOC's to ensure shared objectives are achieved
- Exhibit a solid understanding of the global regulatory legislation, particularly relating to administrative and procedural aspects.
- Good understanding of Global Regulatory requirements and develop specialization in some areas of the RA regulations.
- Participate in (or lead) the development of the SOPs and guidelines,be trained, be a good relay to develop the awareness within the team, act sometimes as a trainer
and follow Company procedures appropriately.
- Participate in (or lead) the Regulatory Interface Team and gives feedback on their specific areas of expertise
PREREQUISITES:
Education: University degree (preferably biological/chemical)
Knowledge:
- Knowledge of Regulatory legislation in at least one geographic area
- Basic understanding of biologicals/vaccines
Experience:
- Ideally more than 4 years experience in the pharmaceutical industry
- At least 3 years RA experience
- Proven ability to manage typical regulatory activities, resolve problems and deliver results
Tags:
Regulatory, RA, Pharmaceutical, Vaccines, Global Regulatory, Affaires, Pharmaceutique, Réglementaires