Head of Regulatory Affairs - Belgium
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Your tasks and responsibilities
- The overall responsibility for all Regulatory Affairs activities for our company in Belgium in order to achieve and maintain registrations in line with the short-term and long-term commercial objectives of the divisions and in compliance with all national and regional regulatory and legal obligations.
- Effectively manage the local Regulatory Compliance, Quality Management (QA) and the Regulatory Affairs Group in order to achieve the timely submission of high quality applications, using appropriate IT tools, in a resource efficient manner
- Representing our company as a competent reliable partner at the local Health Authorities in all regulatory matters.
- Contributing to the development of regional/local Regulatory Strategies for initial registration, life-cycle management and Regulatory Compliance from country/regional perspective.
- Act as a member of the local management team and the European Regulatory Managers team hereby balancing local versus regional needs.
- Playing a role within international regulatory affairs teams concerned with strategy and new applications and decide on local RA strategic and operational matters in coordination with local business management, ERMM (European Regulatory Managers Meeting) and Regional GRA management, including the preparation of local budgets and the hiring and training of staff.
Who you are
- A master degree in pharmacy, pharmacology, chemistry or biological sciences. An industrial pharmacist degree (and license number) is needed to be able to act as Local Quality Representative or deputy towards national Health Authorities
- 5 to 10 years’ experience in Drug Regulatory Affairs, with extensive experience in managing major projects and proven people management experience
- In-depth understanding of the regulatory obligations and guidelines in the country and region
- Experience in operating within a highly regulated environment that is constantly changing
- Leadership personality with team building abilities
- Able to communicate effectively, with proven, persuasive, assertive and negotiation skills
- Convincing presentation skills
- Strong at building relationships and maintaining a partnership with the Health Authorities as your key customers
- Analytical, structured, accurate and well organized to manage, prioritize and process information in an achievement oriented work environment
- Fluent in Dutch, French and English
Our company employees benefit from good employment conditions, such as:
- excellent salary including vacation allowance, smartphone and expense allowances;
- performance bonus and year end premium;
- 34 days off;
- group insurance which contains a defined contribution pension plan, life insurance and disability plan and hospitalization insurance;
- an inspiring working environment with professional and committed colleagues;
- a successful innovative organization;
- international career possibilities;
- challenges and possibilities to learn and to develop;
- personal comfort services.