Regulatory Affairs Consultant

le contenu du travail

• 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.

• Uitdagende projecten in lijn met jouw interesses en talenten
• Persoonlijke opvolging en open communicatie zowel voor als na indiensttreding
• Mogelijkheid tot het volgen van extra opleidingen
• Inspirerende netwerkevents en legendarische afterwork drinks
• Sterk netwerk van toonaangevende klanten
• Expertise binnen IT, Engineering en Life Sciences
• Een vliegende start voor elke junior, verdere groei en kennisdeling voor onze seniors
• Challenging projects based on your interests and skills
• Personal follow-up and clear, transparent communication both before and after commencement of employment
• Possibility to follow extra training
• Inspiring network events and legendary after work drinks
• Strong network of industry leading clients
• Expertise within IT, Engineering and Life Sciences
• A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
  

• Master 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