Associate Director, CMC Regulatory Affairs

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

Position Summary

Neogene is searching for a highly experienced Associate Director, CMC Regulatory Affairs to be responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is based in Santa Monica, CA and reports to the Sr. Director, CMC Regulatory Affairs.

Responsibilities 

• Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams.
• Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g., CMC component(s) of IND / IMPD / Master Files, amendments, annual reports) and health authority interaction briefing documents. Manage and maintain regulatory dossiers as required throughout the product development lifecycle.
• Provide review and compilation and ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
• Represent CMC regulatory affairs on product teams and in health authority interactions.
• Provide regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises.
• Support the development and maintenance of regulatory templates, best practices, and procedures.
• Perform other duties as required.

Requirements

• BA/BS degree in life sciences required, advanced degree preferred (PhD, MS, PharmD).
• 8 or more years of experience in CMC Regulatory Affairs.
• Prior experience in cell/gene therapy.
• In depth knowledge of global CMC regulations and understanding of evolving challenges. and health authority expectations for cell therapies.
• Experience in IND, IMPD, BLA, MAA filings.
• Demonstrated ability to develop/maintain strong working relationships with the cross functional teams, participate on and/or lead multi-functional teams, handle, and prioritize multiple projects and work independently.
• Excellent communication and collaboration skills to work in a fast paced start up environment.
• Proficient leadership skills to successfully lead complex programs. Able to effectively build and lead high-functioning teams.
• Ability to deal with time demands, incomplete information or unexpected events.
• Attention to detail required.
• Outstanding organizational skills with the ability to multi-task and prioritize.

We offer the opportunity to join a highly dynamic biotech company. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

The anticipated salary range for candidates who will work remotely is $160,000 to $215,000 with a bonus target of 20%. In lieu of equity, candidates are eligible to receive a cash retention bonus provided that the candidate remains employed through the first and second work anniversaries. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc. Regular, full-time employees who regularly work an average of 30 hours or more a week, and their dependents, are eligible for to participate in our benefits program. Dependents include your spouse or domestic partner and dependent children up to the age of 26. Unless otherwise indicated, benefits begin on your first day or start date. Benefits include medical, dental, vision, along with financial programs such as a Flexible Spending Account (FSA), Health Savings Account (HSA), Basic Term Life and AD&D Insurance, 401(k) Retirement Savings Plan and optional employee paid benefits. Please see the job description below.

Job Title: Associate Director, CMC Regulatory Affairs  

FLSA Category: Exempt

Department: Clinical Development

Reports to Title:  Sr. Director, CMC Regulatory Affairs

Position Summary

The Associate Director CMC Regulatory Affairs is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is based in Santa Monica, CA and reports to the Sr. Director, CMC Regulatory Affairs.

Essential Functions and Responsibilities 

• Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams.
• Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / Master Files, amendments, annual reports) and health authority interaction briefing documents. Manage and maintain regulatory dossiers as required throughout the product development lifecycle.
• Provide review and compilation and ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
• Represent CMC regulatory affairs on product teams and in health authority interactions.
• Provide regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises.
• Support the development and maintenance of regulatory templates, best practices, and procedures.
• Perform other duties as required.

Supervisory Responsibilities  

• Support hiring, leading and managing workflow and development of staff.

Required Skills/Abilities  

• Demonstrated ability to develop/maintain strong working relationships with the cross functional teams, participate on and/or lead multi-functional teams, handle, and prioritize multiple projects and work independently.
• Excellent communication and collaboration skills to work in a fast paced start up environment.
• Proficient leadership skills to successfully lead complex programs. Able to effectively build and lead high-functioning teams.
• Ability to deal with time demands, incomplete information or unexpected events
• Attention to detail required.
• Outstanding organizational skills with the ability to multi-task and prioritize.

Education and Experience

• BA/BS degree in life sciences required, advanced degree preferred (PhD, MS, PharmD).
• 8 or more years of experience in CMC Regulatory Affairs.
• Prior experience in cell/gene therapy.
• In depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.
• Experience in IND, IMPD, BLA, MAA filings.

Physical Requirements  

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to:  

• Sit and talk or hear  
• The employee frequently is required to use hands to finger, handle, or feel 
• The employee is occasionally required to stand, walk, and reach with hands and arms 
• The employee must occasionally lift and/or move up to 10 pounds
• Specific vision abilities required by this job include close vision and ability to adjust focus in order to read
• The noise level in the work environment is usually moderate
• May be required to travel by plane or car 5% of the time