Director/Senior Director, CMC Regulatory Affairs

Futureshaper.com; Redwood City (CA); On-site; USD 185,000 - 250,000; Full time

Job summary

An established industry player is seeking a Director/Senior Director of CMC Regulatory Affairs to develop and implement regulatory strategies for biologics drug development. This pivotal role involves leading submission efforts, managing relationships with key stakeholders, and ensuring compliance with regulatory requirements. The ideal candidate will have a strong background in CMC regulatory affairs, with at least 8 years of experience, and a proven track record of successful submissions to health authorities. Join a fast-paced environment where your expertise can make a significant impact on the future of drug development.

Qualifications

• 8+ years of experience in CMC Regulatory Affairs with a strong track record.
• Ability to analyze data and draw valid conclusions on regulatory issues.

Responsibilities

• Lead development of CMC regulatory strategy for early/mid-development programs.
• Ensure compliance with regulatory requirements and manage stakeholder relationships.

Skills

Regulatory Knowledge

Interpersonal Skills

Communication Skills

Analytical Skills

Leadership Skills

Judgment on Complex Issues

Education

Bachelor's Degree in a relevant scientific discipline

Advanced degree preferred

Job description

Director/Senior Director, CMC Regulatory Affairs

Title: Director/Senior Director, CMC Regulatory Affairs
Reports To: Vice President, CMC Regulatory Affairs
Location: Redwood City, CA
Classification: Exempt

As the Director/Senior Director, you will develop and implement robust regulatory CMC strategy that align with Clinical, Technical Operations, and Quality functions. You will be responsible for high quality submission packages within target timelines.

Job Responsibilities:

• Leads the development and implementation of CMC regulatory strategy for programs in early-/mid- development stage, in preparation of licensure.
• Actively seeks out regulatory knowledge and incorporates this knowledge into submission planning and execution. Stays current with regulatory requirements.
• Proactively identifies regulatory risks and regulatory opportunities.
• Contributes to the appropriate execution of CMC regulatory strategy, including authoring regulatory documents (e.g. IND/BLA sections and meeting packages).
• Operates with effectiveness across functions.
• Builds and manages relationships through active partnering with key internal and external stakeholders.
• Ensures CMC dossiers meet format and content requirements, as well as specific local requirements of individual countries.
• Analyzes and exercises judgment on complex issues, guided by a thorough understanding of CMC.

Skills and Requirements:

• Bachelor's Degree in a relevant scientific discipline, advanced degree preferred.
• Minimum 8 years of relevant experience in CMC Regulatory Affairs.
• Experience in biologics drug development and license applications.
• Demonstrated track record of successful submissions to FDA and/or other health authorities.
• Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.
• Excellent interpersonal, verbal, and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

The Base Salary Range for this position is $185,000 to $250,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.