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R&D Regulatory Specialist

Remote, CA 00000

Posted: 09/23/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 614877 Is job remote?: No Country: United States

Job Description


Summary:
  • Develops and implements worldwide regulatory programs for marketed products and those in development.
  • Interacts with regulatory authorities to expedite approvals.
  • Participates in the development and leads/executed regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products.
  • Serves as a regulatory representative on cross-functional project teams, applying advanced knowledge of regulations and interpreting technical guidelines to ensure execution of regulatory strategies and requirements.

Job Duties:
  • Develops and implements worldwide regulatory strategies for projects affecting the development of new products, medical devices, or new indications for existing products.
  • Provides regulatory expertise to Research and Development to support project design and analysis.
  • Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.
  • Utilizes scientific training to guide the scope of experimentation and data selection needed for regulatory submissions.
  • Interacts with regulatory authorities regarding impactful programs and initiatives.
  • Advises Management on regulatory aspects of product development and lifecycle management.
  • Identifies risk areas and develops alternative courses of action, including anticipating regulators’ responses through scenario planning and contingency plans.
  • Ensures technical documentation for regulatory submissions meets standards and content requirements, including planning for emerging/changing regulations.
  • Writes documents containing complex scientific information for regulatory submissions.
Job Requirements:
  • Bachelor's Degree in a related scientific discipline with at least 4+ years of experience in Regulatory Affairs or a related field within the Biologics, Biotech, or Pharmaceutical industry.
  • Knowledge of FDA and EU regulations for biotechnology and pharmaceuticals; understanding of global regulatory regulations.
  • Excellent oral and written communication skills; critical thinking and problem-solving skills.
  • Demonstrated project management skills.
  • Ability to interact with regulatory officials.
  • Ability to evaluate complex issues and meet deadlines for compliance and business objectives.
  • Ability to work within a global team framework and multicultural environment.
  • Ability to write comprehensive scientific information for regulatory submissions to the FDA and EU.
  • Ability to manage multiple complex projects and timelines in a matrix team environment.
  • Demonstrated interpersonal skills, including negotiation.
  • Ability to execute regulatory strategies through commercialization/lifecycle.
  • Prior experience bridging several scientific disciplines.
  • Leadership skills within a matrix-driven organization.








Pay Rate Range: $25-40/hr depending on experience 

The staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. 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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Although this hasn't been an issue at Planet Pharma, the staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.