Senior Manager – CMC Regulatory

Location: San Rafael, CA. Hybrid (PST)

12-month Assignment (Potential to convert)

Pay Rate: $80/hr.

As a Senior Manager in the Regulatory CMC department, you will play a pivotal role in ensuring regulatory compliance and contributing to the successful development and commercialization of pharmaceutical products. You will be responsible for planning, preparing, and managing the submission of global regulatory CMC-related content while providing strategic guidance to internal stakeholders.

Key Responsibilities

• Plan, prepare, and submit global regulatory CMC-related content for clinical trial applications, marketing applications, and periodic reports for both US and international markets.
• Ensure all sections are complete, well-written, and compliant with applicable regulatory requirements and strategy.
• Collaborate with Regulatory CMC Product Leads to evaluate proposed manufacturing changes and provide regulatory strategies for efficient implementation.
• Offer expert regulatory advice to technical teams based on current Quality (CMC) requirements.
• Develop, review, and ensure the accuracy and completeness of regulatory documents for submission.
• Maintain alignment with program milestones by managing timelines and deliverables.
• Manage communications with global regulatory authorities (e.g., FDA, EMA, Health Canada) for assigned projects and respond to queries.
• Build and maintain strong relationships with cross-functional teams, including Regulatory Affairs, Manufacturing, Technical Development, and Quality.
• Support submission preparation by managing documentation requests and ensuring timely delivery.
• Proactively identify potential regulatory issues and escalate them for resolution as needed.

Education and Qualifications:

• Bachelor’s degree in life sciences, chemistry, molecular biology, or a related field, and 6+ years with a strong background in Regulatory Affairs with a focus on CMC operations.
• Demonstrated ability to manage complex regulatory submissions and timelines.
• Proficient in addressing global regulatory requirements for both US and ex-US markets.
• Expertise in managing health authority interactions.
• Familiarity with regulatory operations and technical documentation.

Please submit a copy of your resume in Word or PDF format to be considered.