Manager, CMC Regulatory (Fixed-Term Contract)

Company introduction:

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, and has offices in New York City and San Francisco in the US.  We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments. 

We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways.

Job overview:  

Step into a pivotal role as our CMC Regulatory Manager, where you will support the development and execution of the CMC regulatory strategy, authoring and reviewing the critical submissions that will shape the pathway for our first-in-class investigational product.

Location: Hybrid in our New York City office or remote on the East Coast, USA.

Reports to: Associate Director, Regulatory Affairs CMC.

Roles and responsibilities 
(Include but are not limited to): 

• This role is pivotal in liaising with cross-functional teams to prepare and maintain CMC sections of submissions, as well as responding to Health Authority queries throughout the product lifecycle
• Participate in the development of the CMC regulatory strategy
• Author and review CMC regulatory submission documents including: IND updates, NDA filings, and responses to health authorities through collaborations with relevant line functions
• Review technical documentation, as necessary
• Develop CMC strategies, assess risks, and develop contingency plans
• Develop and maintain knowledge of regulatory environment, regulations, and procedures
• Prepare and review CMC regulatory documentation and identify any potential risks including content, quality, or timeline issues as early as possible
• Collaboration with cross-functional teams to gather input and provide feedback and guidance

Candidate Profile:

• Bachelor's Degree in life sciences or engineering, or other technical discipline
• Considerable industry experience, with 3+ years in CMC regulatory specifically
• Experience with CMC regulatory documents (IND/CTAs, NDAs, MAAs, responses, etc)
• Knowledge and understanding of FDA, EMA and/or ICH guidelines and CMC regulations
• Experience in drug development processes and post-approval requirements
• Experience in developing CMC regulatory strategy
• Excellent communication skills, both written and oral

Benefits & Compensation:

For an overview of our benefits package and compensation information, please visit  "Working at Compass".  

Equal opportunities: 

Reasonable accommodation

We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. 

UK applicants

We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.

US applicants

Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.

Sponsorship:

Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.

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