1+ months

Regulatory Strategist

+ **Why Patients Need You**

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

**What You Will Achieve** As a Regulatory Strategist, you will be part of a team that will guide Pfizer by interpreting federal, state and international regulations as they apply to products, processes, practices and procedures. In this role you will be responsible for product registration activities of the assigned products and will report to the Regulatory Strategy Sr Manager.

You will work in cross-functional teams with different Puurs departments (manufacturing, labs, QA, supply,...) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC) in order to support the introduction of new products in the site.

It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

**How You Will Achieve It**

+ Support regulatory submissions (CTD, BLA) of the products by informing site colleagues of regulatory requirements and by authoring the dossier.

+ Liaise with regulatory colleagues to communicate and resolve potential issues.

+ Collaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance of Pfizer portfolio.

+ Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility.

+ Assess Post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier.

+ Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals . **Qualifications**

+ Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..)

+ Minimum 2 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA) and quality.

+ Scientific knowledge, analytical skills associated with technical writing skills to issue RFT regulatory documentation

+ Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA)

+ Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.

+ Dynamic, flexible, enthusiastic and eager to learn

+ Ability to work under minimal supervision and in a team

+ Fluent in written and spoken English and Dutch


De Pfizer site in Puurs is n van de grootste productie- en verpakkingssites van Pfizer wereldwijd, gespecialiseerd in aseptische productie en verpakking. Jaarlijks worden in Puurs meer dan 400 miljoen doses injecteerbare vaccins en medicijnen geproduceerd. Deze zijn ter plaatse verpakt in ampullen, flacons, plastic flessen, spuiten en patronen voor pennen.

De medicijnen die in Puurs worden gemaakt, zijn bestemd voor patinten in meer dan 170 landen wereldwijd. 30% van de productie uit Puurs is bestemd voor ontwikkelingslanden, in samenwerking met UNICEF, WHO, GAVI en ngo's. In Puurs werken meer dan 2800 medewerkers.

Met het gebruik van twee windturbines, zonnepanelen en een warmtekrachtcentrale richten we ons op hernieuwbare energie.

Regulatory Affairs


Posted: 2021-02-04 Expires: 2021-05-09

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