Regulatory Affairs Associate
- Experience Level
- Experienced (non-manager)
An international pharmaceutical company is seeking to hire a Regulatory Affairs Associate to their office in Brussels. The organisation produces health, hygiene, and home products, along with other multinational consumer goods. This is an exciting opportunity to provide regulatory expertise, ensuring that all regulatory activities are carried out according to best process.
- Manage a complex and diverse set of registration/regulatory requirements across multiple markets and brands to enable the strategic delivery of a global pipeline.
- Contribute to the development of regulatory strategies to enable successful registration in global markets with a focus on New Product Development.
- Maintain and develop knowledge and intelligence across the Regulatory Function to build 'right first time' approach with respect to registrations globally.
- Collaborate with partner functions to agree market specific data requirements and delivery timelines.
- Develop excellent working relationships with local (regional) regulatory colleagues to facilitate aligned regulatory plans and shared learnings to ensure efficient speed to market.
- Create strong and proactive relationships with all partner functions.
- Work collaboratively with Snr Manager/Manager in order to define and implement the regulatory strategy.
- Assist in monitoring, collecting, interpreting and sharing with business partners, regulatory issues and trends that will impact RB products, policies and procedures. Assist in the development of strategies and plans of action to address them.
- Assist in the preparation of responses to address significant safety, regulatory and PR issues in the assigned Category.
Skills and Requirements:
- Educated in a scientific field or equivalent experience. Honours degree is a plus.
- Minimum 6 months regulatory experience and knowledge in dossier / technical file creation, variations and renewals.
- Ideally experience in medical products (preferably OTC) regulations. Other regulations would be a plus e.g. medical devices, cosmetics.
- Understanding of global product development practice, rules, regulations and guidelines.
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries.
- Fluent in English, Dutch, and a strong preference for French, or French language skills that can be developed.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at +44 203 761 5702 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.