Site Regulatory Strategist
il y a 3 semaines
Location:
**PUURS**
- Type:
**Contracting**
**#20948**
Will you be our new ambassador?
**Jefferson Wells Life Sciences** specializes in supporting **pharma & biotech companies** in their daily challenges. Hence our interest in **experts** like you to join our team.
Let's look together at your first challenge with us
**Site Regulatory Strategist**
**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 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.
**Profile**
- 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
**What can Jefferson Wells do for you?**
As an ambassador you have the opportunity to grow within international companies where you can build a **strong network**. Through a personal **follow-up**, you receive **quality support** in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal **training** and **education**.
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