Regulatory Specialist and Senior Specialist
il y a 2 semaines
Regulatory Affairs Specialist
Antwerpen – contracting
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 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?
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, CMC) 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.
Fluent in Dutch & English (written and spoken)
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply.
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