(Senior) Regulatory Affairs Manager

(Senior) Regulatory Affairs Manager

Why Patients Need You

Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Interested to join our dynamic Pfizer’s Regulatory Affairs Belux Team that is dedicated to bring Breakthrough’s that change patient’s lives to the Belgium and Luxembourg market? Then check this job opening within our team

You will represent Pfizer as a (Senior) Regulatory Affairs Manager in the Regulatory Affairs Belux team. The purpose of this position is to allow Pfizer to legally study, manufacture, market and supply medicines by obtaining, managing and maintaining product Marketing Authorisations and Clinical Trial Authorisations in line with business goals and legal requirements.

The Position
- To conduct associated regulatory activities for the Belux markets and to contribute to the implementation and leading of national/regional/global projects within regulatory, as well as cross-functionally and cross-divisionally and building of expertise within the Regulatory Department, Global Regulatory Affairs-International (GRA-I) and Global Product Development (GPD), striving for continuous improvement of regulatory processes.
- To provide regulatory advice and liaise with key customers and relevant stakeholders, contribute to the strategic regulatory input into cross-functional product teams for licensed and development products.
- To build effective relationships with the local Regulatory Authority and represent the company at the regulatory committee(s) of the national Trade/Professional Association(s), when needed.
- To support Cluster Lead/HRA and/or Team Leaders in building expertise within team and ensuring compliance with Company and statutory responsibilities.
- Oversee any assigned contractors to achieve agreed objectives, with high quality outputs, and to identify and address training and development needs.
- To support the Cluster Lead/Head of Regulatory Affairs and/or Team Leaders to make decisions that require developing innovative options to resolve complex problems.
- Build personal expertise through management of specified products within one or more therapy areas.
- Ensure timely communication about regulatory approvals and implementation dates and liaise with responsible for Artwork coordination and/or Supply/Demand and other logistics functions to plan for component updates and to ensure their introduction within required regulatory compliance timelines.
- This is an individual contributor role.
- Possible location : Brussels, Avenue de la Plaine. For this position we do not offer relocation. Please note this is not a remote role.

Your skills
- Pharmacy, Life sciences or Chemistry graduate to honours level or equivalent through work experience.
- Master’s Degree, Post Graduate Diploma or PhD preferred.
- A minimum of 8 years’ experience and proven track record in Regulatory Affairs (Human Medicinal Products).
- Strong knowledge of the Belux and European environment, rules, regulations and procedures, and how this impacts regulatory strategy and implementation.
- Insight and understanding of internal and external shareholders needs and requirements. Previous experience in bringing new products to the market and working cross functionally to achieve this, is an asset.
- Computer literacy: good knowledge on use of MS Word, Excel, PowerPoint, Outlook. Experience in using electronic document management systems and other electronic tools.
- Ability to work under mínimal supervision and in a team.
- Accurate, organised and problem solving; stress resistant, able to meet concurring deadlines.
- Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
- Analytical thinking; quality and compliance oriented.
- Able to coach or mentor other colleagues and share information and knowledge.
- Previous experience or demonstrated capability of coaching and mentoring.
- Leadership capabilities.
- Languages: Fluent in written and spoken Dutch, French and English. German knowledge is an asset.

What we can offer

At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Pfizer's open-door policy is an integrated part of our culture across all levels of seniority.
- Permanent contract
- Flexibility: homeworking up to 3 days per week and flexible work