Manager, Global Regulatory Sciences - Contract - Cambridge, MA
We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.
Proclinical is seeking a Manager for the Global Regulatory Sciences team.
Primary Responsibilities:
The successful candidate will support and implement global regulatory strategies to advance our client's mast cell disease portfolio. In this role, you will work closely with the Global Regulatory Lead(s) and cross-functional teams to develop, register, and maintain compounds in mast cell disease indications. Effective communication and collaboration with external partners and regulatory authorities are key aspects of this position.
Skills & Requirements:
- Bachelor's degree in a scientific discipline; advanced degree preferred.
- Experience in drug development; direct regulatory experience beneficial.
- Familiarity with oncology/rare diseases drug development is advantageous.
- Experience with IND filings and management with the FDA.
- Knowledge of US regulatory requirements; EU, Canada, ROW knowledge a plus.
- Strong interpersonal and communication skills.
- Detail-oriented and capable of managing multiple tasks.
- Collaborative and open communicator.
- Proficient in Microsoft WORD, Excel, PowerPoint, SmartSheet, and Adobe Acrobat.
The Manager, Global Regulatory Sciences' responsibilities will be:
- Assist in managing regulatory aspects of clinical development programs.
- Handle relevant submissions for assigned programs.
- Represent the Global Regulatory Sciences function on cross-functional teams.
- Support in developing and implementing product regulatory strategies and plans.
- Lead preparation efforts for health authority meetings.
- Provide guidance to external vendors and consultants.
- Monitor new regulatory requirements and advise teams on their impact.
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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