Regulatory Affairs Manager/Senior Manager Regulatory Affairs CMC South San Francisco, California

Client is seeking a highly motivated and experienced Manager/Senior Manager, CMC Regulatory Affairs to join the Regulatory team. The successful candidate will be responsible for developing and executing global regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for small molecules and biologics. This role requires a strong scientific background to effectively support product development and registration activities while ensuring compliance with global regulatory requirements.

• Develop and implement CMC regulatory strategies for investigational and marketed products to ensure successful regulatory submissions and approvals.
• Author or review CMC sections of regulatory submissions (INDs/CTAs, BLAs/ NDAs/MAAs, IND amendment/IMPD modification, supplements/variations, annual reports, etc.) to ensure that all submissions are complete, accurate and meet relevant requirements.
• Collaborate cross-functionally with CMC SMEs (drug substance team lead [DSTL], drug product team lead [DPTL]), analytical science team lead [ASTL] to align CMC regulatory strategies with business objectives.
• Manage the timelines and deliverables to ensure submissions are aligned with program milestones.
• Provide scientific and CMC regulatory expertise for change assessments of proposed manufacturing changes and strategic regulatory guidance for optimal implementation to cross-functional stakeholders.
• Lead and manage CMC-related interactions with health authorities, including preparing responses to regulatory inquiries and participating in agency meetings (FDA, EMA, HC, etc.).
• Stay up to date on global regulatory requirements and guidance from agencies such as FDA, EMA, HC and ICH to ensure compliance and implement best practices.
• Contribute to the development and maintenance of Regulatory Intelligence to anticipate regulatory trends and requirements impacting CMC strategies.
• Work in regulatory and quality databased via Veeva platform.

Compensation Details:

• We provide a reasonable range of compensation for this position. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $80-$90 per hour. It is possible that this position can be hired outside of this salary range based on experience.

EEO and Reasonable Accommodation Statement:

Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.

We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.