Regulatory Affairs Strategist

**Omschrijving**:

- Location: Remote with at least 2 days on site._

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
- 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.

**Profiel**
- Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..)
- Minimum 3 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 mínimal supervision and in a team
- Fluent in written and spoken English

**Aanbod**

In exchange for your expertise and commitment, we offer you a permanent contract as a consultant. We also act as your career planner, seeking the best opportunities, training programs, and growth prospects for you. Together, we plan follow-up sessions every three months to assess the progress of your projects and identify areas where you may need further support.

In addition to an attractive gross salary, you will enjoy various fringe benefits:

- Numerous internal training and advancement opportunities with the client.
- Option for a company car with a fuel card (also available for personal use).
- Free health and group insurance coverage.
- Meal vouchers worth 8 euros each.
- Fixed monthly allowance based on your experience.
- Mobile phone subscription (with free calls and texts + 12GB data).
- 13th-month bonus, eco vouchers, sports, and cultural vouchers.

We place great importance on investing in our interim managers, consultants, and freelancers. This includes providing a range of training programs as well as organizing events and team-building activities.

**Bedrijfsinfo**

Onze klant is een van de grootste farmaceutische bedrijven ter wereld. De site in regio Antwerpen is de grootste productie
- en verpakkingssite in Europa.

Je komt in een cultuur terecht waarbij **ownership **een essentieel kenmerk is van elke collega en waar ze ook sterk geloven in teamwerk. Streven naar hoge **kwaliteit **is de rode draad in alles wat ze doen.