Director, CMC Regulatory Affairs

COMPASS Pathways Remote
director cmc cmc regulatory affairs regulatory cmc regulatory management compass strategy ra health manufacturing mental
November 5, 2022
COMPASS Pathways
New York, NY
FULL_TIME

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.

Company overview:

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 Vice-President, 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

Profile:

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)

Equal opportunities:

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.

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.


Report this job

Similar regulatory cmc jobs in manhattan ny