The CMC Regulatory Affairs Director will be responsible for leading the development and implementation of CMC regulatory strategies for products throughout development and commercial lifecycles.
COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving 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 therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support.
COMP360 has been designated a Breakthrough Therapy by 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). We have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com.
Location: Remote in the United States & United Kingdom or hybrid in our New York (USA) or London (UK) office.
Reports to: Senior VP, Global Regulatory Affairs
Roles and responsibilities:
As the anchor for Global Regulatory Affairs CMC, you will interface with outside regulatory agencies and CMO providers and act as an advisor/liaison between senior management and third parties and on behalf of COMPASS for planning, evaluating, and executing of regulatory CMC strategy that supports the Compass mission and business proposition.
- Develop global Regulatory CMC strategies and updates based on regulatory and business changes
- Act as CMC regulatory expert for global project teams/task forces and is accountable for recommending global CMC regulatory strategy. Build and manages relationships through active partnering with key internal and external stakeholders
- Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others
- Will also impact global strategy directly by participating in CMC strategic planning in therapeutic area with global stakeholders for CMC
Act as the CMC Regulatory representative for all CMC RA Compliance initiatives as well as governing teams in charge of manufacturing activities or initiatives:
- Provide leadership of global GRA CMC strategists plus manage global temporary resources to both set strategy and execute against the various strategy
- Reviews, evaluates and approves CMC strategies associated with all initiatives
- Ensure team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions (e.g. Emerging Markets RA) to ensure effective strategies are developed and project execution is on target. Represent as required CMC viewpoint/analysis in the evaluation of new product opportunities internally and externally
- Demonstrated track record for successful CMC interactions with FDA and other global health authorities related to CMC/Quality submissions, including relationship management and constructive partnering with international Health Authorities (such as FDA, EMA, etc.)
- Responsible for managing budgetary resources as required
- Provides leadership of global GRA CMC business units consisting of geographically dispersed RA CMC professionals, including staff management and development
- Represents Global CMC Regulatory on providing guidance to Supply Chain (PSC/GIO) , Quality Assurance, 3rd Party Contract Management, Commercial and wider GRA on both global project and key strategic business initiatives
- Has written and verbal proficiencies to explain, outline, and articulate CMC concepts and processes in regulatory documents, at Regulatory Authority interactions, and in situations that require RA CMC support of Quality and CMC Technical staff when called upon and/or during risk mitigation and inspection-related activities
- Identifies key risks to the business associated with submission CMC /Product Quality strategy for information packages, meeting background packages and provides clear communication to senior management with well defined risk mitigation strategies
- Likely to have management and educative responsibilities. Coaches and mentors staff across RA on lifecycle management in CMC
- Leads influences and motivates staff within and across departments
- Commercially astute and organisationally aware and able to deal with sensitive and confidential issues
- May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects
- Delivers CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (LICs/PIRCs). Is knowledgeable in product lifecycle management
- Has CMC RA authorship and accountability responsibilities for submission content of all regulatory science documents for dossiers and filing that relay CMC information/data
- Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications in alignment with regional requirements
- Responsible for reviewing and signing off on all COMPASS relevant CMC change controls and working with Quality Control to ensure COMPASS proprietary manufacturing processes are optimally and compliantly being provided with suitable tracking, control, and accountability of process changes and/or improvements
- Supports license maintenance and change control requests including transfer of supply within the company or with a 3rd party are delivered to agreed timelines
- Operates with independence. Directs and communicates complex regulatory issues independently at senior levels across the company and with external agencies and third parties as necessary
- Responsible for team compliance with COMPASS policies and procedures, staff development and training to deliver roles
- Advanced Degree ( MS/Ph.D or equiv.) - life sciences or related scientific discipline
- Able to demonstrate the following key high performance behaviors: customer driven, flexible thinking, and continuous improvement
- Excellent writing skills and the ability to collaborate on writing assignments with technical CMC colleagues
- Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise
- Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
- Considerable experience in managing and enforcing quality maintenance with CMOs partners
- Can handle complex global CMC issues through continuous change and improvement
- Experience in leading major post-approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management)