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Regulatory Affairs Manager III - Part Time

Oakbrook, MA 60523

Posted: 04/10/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 603098 Is job remote?: Yes Country: United States

Job Description

Pay is commiserate with experience and ranges between $100-120/hr

This role is responsible for participating in cross-functional teams responsible for the development and life cycle management of combination products/devices. The candidate utilizes expertise to provide Regulatory CMC global regulatory strategy, support development activities and execute combination product submission deliverables.

This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, Regulatory CMC knowledge and interpersonal skills are required.

• Provides strategic and operational Regulatory CMC expertise and support in cross-functional teams, working flexibly within and across regions to provide broad operational support to ensure the delivery of project and business objectives.
• Participates in cross-functional teams responsible for development of combination products / devices.
• Ensures global regulatory CMC combination product / device strategy for assigned combination products are consistent with the team and business goals and meet Health Authority requirements.
• Ensures effective communication of CMC regulatory strategy, risks, and overall plans.
• Identifies supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
• Prepares, authors and delivers applicable sections (IND/IMPD/CTAs/BLAs/MAAs) and full regulatory submissions (Notified Body Opinion). Responsible for submission from defining and agreeing content to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities.
• Authors and/or review of global CMC submission responses and supporting documentation to Health Authority questions in line with agreed global regulatory strategy and timelines.
• Provides input into Regulatory CMC risks assessment and mitigation plans and ensuring that it remains in line with the overall global Regulatory CMC strategy.
• Participates in cross functional workstreams and initiatives, as assigned by management.

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.