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Manager, Global Regulatory Sciences
45 Sidney Street, 001 Cambridge, MA 02139 US
Job Description
- Support line manager with the day-to-day management of regulatory aspects of at least one clinical development program
- Responsible for relevant submissions for assigned program(s).
- Represent the Global Regulatory Sciences function on cross functional teams
- Support line manager in developing and implementing long?and short-term product regulatory strategies/plans
- Plan for and lead preparation efforts for health authority meetings
- Provide guidance to external vendors and consultants as needed
- Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs
- Bachelor’s degree in scientific discipline; advanced scientific related degree a plus
- 4 years or more in drug development; direct Regulatory experience is a plus
- Experience in oncology/rare diseases drug development a plus
- Ideally experienced in filing and managing INDs to FDA
- Working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plus
- Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships
- Well organized, with an attention to details and capable of managing multiple deliverables
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
- At home in a results-driven, highly accountable environment where you can make a clear impact
- A team player, who listens effectively and invites response and discussion
- Flexible and adaptable in ambiguous situations
- Must be proficient in Microsoft WORD, Excel, PowerPoint as well as SmartSheet and Adobe Acrobat
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Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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