Senior/Executive Director, CMC Regulatory Affairs

Title:                                    Senior/ Executive Director, CMC Regulatory Affairs
Reports To:                        Senior Vice President, Regulatory Affairs
Location:                             Redwood City, CA
Classification:                    Exempt 
 
As the Senior/Executive Director, CMC Regulatory Affairs role, you will be accountable for all CMC-related aspects of one (or several) program(s), including submission planning, regulatory strategy and execution.

Job Responsibilities:

• Leads the development and implementation of CMC regulatory strategy to support global development program(s) and Biological License Applications.
• Responsible for ensuring the appropriate execution of CMC regulatory strategy.
• Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions.
• Manages CMC regulatory risks.
• Builds and manages relationships through active partnering with key internal and external stakeholders.
• Ensures CMC dossiers meet high quality standards.
• Stays current with regulatory requirements and initiates process improvements as appropriate.
• Analyzes and exercises judgment on complex issues, guided by a thorough understanding of CMC.

Skills and Requirements:

• Minimum 8-10 years of relevant Biologics experience in Regulatory Affairs CMC.
• Experience in Biologics drug development, market applications and commercial lifecycle.
• Bachelor's degree in a relevant scientific discipline, advanced degree preferred.
• Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA.
• 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.

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.