Director/Senior Director, CMC Regulatory Affairs

Coherus BioSciences; Redwood City (CA); On-site; USD 185,000 - 250,000; Full time

Job summary

An established industry player is seeking a Director/Senior Director for CMC Regulatory Affairs to spearhead regulatory strategies for biologics development. This pivotal role involves leading the creation of submission packages, ensuring compliance with regulatory standards, and building strong relationships with stakeholders. The ideal candidate will bring over 8 years of experience in regulatory affairs, with a proven track record of successful submissions to health authorities. Join a dynamic team where your expertise will directly impact the advancement of innovative therapies in a fast-paced environment.

Qualifications

• 8+ years of experience in CMC Regulatory Affairs with a focus on biologics.
• Strong track record of successful submissions to FDA and other health authorities.

Responsibilities

• Lead CMC regulatory strategy development for early- to mid-stage programs.
• Ensure high-quality submission packages are delivered within timelines.

Skills

Regulatory Affairs

Biologics Drug Development

Submission Planning

Interpersonal Skills

Analytical Skills

Communication Skills

Education

Bachelor's Degree in a relevant scientific discipline

Advanced Degree (preferred)

Job description

Director/Senior Director, CMC Regulatory Affairs

Redwood City, CA

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 aligns 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.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

** We are currently not accepting any unsolicited resumes from recruiters or employment agencies. **

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