Search Jobs
Manager, Global Regulatory Sciences
45 Sidney Street, 001 Cambridge, MA 02139 US
Job Description
Responsibilities:
- 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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Cambridge, MA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.