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 Affairs Consultant
As a Regulatory Affairs Consultant, 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) to support the introduction of new products at Pfizer 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.
Scope of work:
- 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 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.
- Master’s degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer…)
- 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
- CMC experience is a real asset
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.