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, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments.  

We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area.

We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - 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.

Duration: 18-month fixed-term contract.

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.

Data Privacy:

All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.