Do you have experience in Regulatory and Registration (at least 3 years)? Are you fluent in English and Dutch? And ready to work in Puurs? Then we have a match.
As a Regulatory Strategist, you will be part of a team that will guide our client 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 at our client Puurs site. It is your hard work and dedication that will make our client ready to achieve new milestones and help patients across the globe.
- Support regulatory submissions (CTD, BLA, NDA,…) 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 Our client 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.
- Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..)
- Minimum 4 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
- A balanced salary package based on your capabilities and experience, including meal vouchers.
- Full time position
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacature nummer: 17934