Regulatory Affairs Director
1 week ago
This position is responsible for providing leadership in regulatory affairs, overseeing teams responsible for regulatory submissions worldwide. The successful candidate will provide strategic support and guidance to clients and team members in the area of clinical development of human medicinal products.
Key Responsibilities- Establish operational objectives and assignments for assigned team members.
- Track and report regulatory function metrics and key performance indicators.
- Oversee, review and provide strategic input on applications to Regulatory Authorities.
The ideal candidate will have a strong understanding of regulatory milestones, extensive knowledge of all aspects of the drug development process, and be able to communicate complex information to senior management.
Required Skills and Qualifications- Post Graduate Degree, Bachelors degree, or equivalent experience in a scientific or healthcare discipline.
- 10+ years or more relevant regulatory affairs experience in CRO, Pharma, Biotech or related industry.
- Extensive and broad knowledge and experience of all aspects of drug development process.
- A dynamic and growing organization with a passion for oncology and rare diseases.
- A collaborative and respectful work environment.
- Ongoing training and professional development opportunities.
- Foster a culture of mutual respect and collaboration.
- Ability to prioritize and delegate tasks.
- Results oriented, accountable, motivated and flexible.
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