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Regulatory Affairs Manager III - Part Time
1 Lincoln Center Oakbrook, MA 60523 US
Job Description
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.
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.
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