- Ensure timely preparation, submission and appropriate follow-up of variations and renewal applications. Act as contact person with local authorities.
- Respond to questions from regulatory authorities in agreement with the Global Regulatory Lead.
- Ensure high quality labeling translation and artwork management
- Review promotional materials for compliance with local regulations
- Maintain good relationships with internal (Global Regulatory Leads, Pharmacovigilance, Business partners, Market Planners, ...) and external regulatory contacts (local regulatory authorities)
- Monitor applicable EU and local regulations, perform impact analysis where needed and keep internal partners appropriately informed.
- Provide regulatory guidance to business, tenders and project teams
- Support Corporate Quality Systems implementation including local requirements to CQA and distribution
- Coordinate Field Actions implementation
- Handle non conformities, CAPA and change controls
- Provide support in case of inspections
- Bachelor's degree or country equivalent in a relevant scientific field
- Preferable prior work experience in regulatory or equivalent experience within a pharmaceutical/medical device company, CRO or similar organization
- Native fluency in Dutch or French, with proficiency in English and in the second national language (Written and spoken)
- Office basic knowledge required
- Good interpersonal and communication skills: ability to collaborate closely with different functions involved and with multicultural teams
- Organizational and project management skills, self-motivation and commitments
- Certified RIP from Belgian FAMHP is a plus
- IT functional knowledge in Veeva Vault RIM & PromoMat, TrackWise is an asset
- Proficiency in German is appreciated
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Regulatory Affairs Specialist - Braine-l'Alleud, België - Baxter
Beschrijving
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Your Role at Baxter
This is where your motivation addresses challenges
Your Team at Baxter
The Specialist (f/m/d) RA belongs to the Benelux CQA and RA department, reports to the CQA/RA Manager Benelux and is responsible to ensure that the product registration lifecycle and related processes are ensured in Belgium, Luxembourg, and the Netherlands
The Regulatory function values both working together as a team and independently. We draw energy from working in collaboration with internal and external stakeholders. As the company evolves, so does the way our team approaches work as it strives to create new development opportunities and new ways of working.
What you will be doing:
RA Role
For Renal and Acute Therapy products:
QA Support
What you will bring:
