Regulatory Strategist

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

 Regulatory Strategist

Our partners innovate to bring treatments to their patients that significantly improve their lives. Together with the government and other health partners, they are working towards qualitative, affordable and accessible healthcare.

As a Regulatory Strategist, you will be part of a team that will guide the company 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 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 the site.

What are your responsibilities?

• 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 the company's 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.

Who are you?

You have a master degree in life sciences (industrial pharmacist, biomedical sciences, bio-engineer,…). You have the knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA). You have minimum 2 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA) and quality. You have scientific knowledge, analytical skills associated with technical writing skills to issue RFT regulatory documentation. You are fluent (both written and spoken) in English and Dutch. You are dynamic, flexible, enthusiastic and eager to learn. You can work under minimal supervision and in a team.

What can Jefferson Wells do for you?

As an ambassador, you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Are you interested in this position? Don't hesitate to apply and/or contact our recruiter Ilska for more information: ilska.cremers@jeffersonwells.be.