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Senior Manager - CMC Regulatory
770 Lindaro Street San Rafael, CA 94901 US
Job Description
As a Senior Manager in the Regulatory CMC department this individual will be responsible/accountable for:
RESPONSIBILITIES
Planning, preparation and submission of global regulatory CMC-related content pertaining to clinical trial applications, marketing Application(s) and periodic reports for US and Ex-US markets in accordance with the developed regulatory strategy. Ensure that the sections are complete, well-written, and meet all relevant requirements.
Collaborating and staying aligned with Reg CMC Product Lead to assess change records of proposed manufacturing changes and provide strategic regulatory guidance for optimal implementation of changes.
Developing and reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.
Manage the timelines and deliverables to ensure submissions are aligned with program milestones.
Proactively identify issues and escalate.
Develop relationships with Regulatory Affairs, Manufacturing, Technical Development, Sites, and Quality to support submission preparation.
Provide regulatory advice to technical subject matter experts based on knowledge of current Quality (CMC) requirements.
Process documentation requests to support key application activities
Manage interactions with country regulatory authorities (FDA, EMA, HC, etc) for assigned projects relating to health authority queries.
Requirements:
- BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable. Advanced degree is a plus.
- COMMUNICATIONS OPERATIONS
- REGULATORY AFFAIRS
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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