We are seeking a highly skilled Senior Manager - CMC Regulatory to lead the planning, preparation, and submission of global regulatory CMC-related content for clinical trial applications, marketing applications, and periodic reports. This role involves ensuring compliance with US and international regulatory requirements, collaborating with cross-functional teams, and providing strategic guidance on manufacturing changes to optimize regulatory submissions. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, apply today!
Location: San Rafael, CA (Hybrid, must be based in PST - West Coast, California)
Position Type: Contract for 1 year (through January 2026)
location: San Rafael, California
job type: Contract
salary: $68.56 - 80.66 per hour
work hours: 9 to 5
education: Bachelors
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.
qualifications:
- Bachelor's degree (BA / BS) degree in Life Sciences in Chemistry, Molecular Biology, or similar is desirable.
- Advanced degree is a plus
- Strong expertise in regulatory affairs, communication operations, and CMC processes.
- Excellent communication skills, written and verbal
- Strong attention to detail
- COMMUNICATIONS OPERATIONS
- REGULATORY AFFAIRS
skills: CMC, Regulatory Affairs Operations, Submissions, Manufacturing Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
