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 Regulato
...regulatory affairs consultant.
- posted 10 june 2022
- closes 8 august 2022
qualifications
- 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
- CMC experience is a real asset
key 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 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.
key benefits
As an answer to your high performance & flexibility, Randstad Professionals offers you an interesting salary package, with some interesting extras like:
- Meal vouchers of €7
- Net representation cost of €80
- Hospitalization insurance
- Car + unlimited fuel card OR home-work compensation
- 32 holidays
- End-of-year bonus
- Pension plan
- ECO vouchers
- Opportunities to follow trainings
- And on top of this you'll improve your skills and become an even bigger expert!
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JH
jef huybrechts
