Manager, CMC Regulatory

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MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. More information about the organization is available at mapspublicbenefit.com.

MAPS PBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other. We value transparency, autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing.

MAPS PBC advances equity and inclusion in the workplace by providing equal employment opportunity to support a work environment free from discrimination on the basis of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, military and veteran status, arrest or conviction record, and any other basis prohibited by law. The organization also provides reasonable accommodations for qualified applicants and employees with disabilities. This equal employment opportunity policy applies to all aspects of employment, including recruitment, selection, advancement, training, problem resolution, and separation from employment. Through this policy, MAPS PBC strives to establish and maintain an equitable and accessible work environment that is supportive and free from discrimination.

Position Summary

Reporting to the Director of CMC and Project Management, the Manger, CMC Regulatory will be responsible for chemistry, manufacturing and controls (CMC) regulatory writing for all MAPS PBC programs and/or studies including investigator-initiated trials (IITs). This will include at a minimum, submissions for FDA, Health Canada and seven EU regulatory authorities (RAs).

They will work with the Director to define both IND and NDA CMC writing and submissions strategy. They will track and maintain all CMC regulatory related supporting documents and data. They will also work cross-functionally within the department and across MAPS PBC and MAPS Europe B.V. to plan and maintain CMC and submission timelines according to internal and regulatory requirements.

This position requires CMC technical writing and project management skills along with experience of FDA and rest of word (ROW) CMC regulatory submission formats and requirements, including CFR 21 and ICH M4Q(R1).

 

Location

This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required. This position requires frequent phone and internet meetings. Certain home office expenses may be reimbursed. A work computer will be provided.

 

Hours

Full time 40 hours per week. Applicants must be available 40 hours a week, during normal business hours (9:00 AM – 6:00 PM Monday-Friday). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.

 

Position Duties

• CMC regulatory writing for all program/study level submissions in US and ROW including support and/or writing for third-party IITs.
• CMC regulatory writing for Annual Reports and DMF updates.
• CMC regulatory writing for eventual NDA submission for DS/DP.
• Support Director with defining IND and NDA writing and submission strategy including RA meeting requests and briefing packets.
• Coordinate with contract manufacturing organizations (CMOs) meeting submissions requirements and questions.
• Coordinate timely receipt and tracking of all CMC related documentation including but not limited to DS/DP: analytical protocols, reports and monographs; GMP development and campaign reports and associated documents, stability protocols and CoAs, QP declarations and batch releases, batch records, validation protocols and reports.
• Support Director with vendor(s) searches and qualifications as needed.
• Ensure timely updates to COAs via third-party contract manufacturing organizations (CMOs) and provision to other vendors as needed.
• Write and track re-test update memos for DP and ensure timely provision to Clinical Operations department as needed.
• Write overall stability summaries for internal guidance around shelf life and storage requirements, ensuring timely updates as needed according to new or revised stability information on both DS/DP.
• Write and review CMC regulatory SOPs and associated documents.
• Maintain overall CMC IND and NDA regulatory and submission timelines using Smartsheet Gantt charts.
• CMC planning for regulatory filings and create tracker to track status of CMC-related modules.
• Stay abreast of CMC regulatory requirements in US and relevant ROW countries.
• Support planning and eventual CMC writing of ROW licensure submissions following NDA submission, including at a minimum EU marketing authorization application.
• Support third-party investigators outside of IITs for CMC regulatory as needed.
• Other tasks related to CMC as required.

 

General Responsibilities

• Communicate and collaborate with key players, internal and external staff
• Check in regularly with supervisor and complete assignments by agreed deadline
• Document processes and provide regular updates
• Proactively seek methods of improvement, streamlining workflows and building efficiencies in individual work and project outcomes

 

Minimum Requirements

• Bachelor’s degree in biology or chemistry; advanced degree in the life sciences desirable.
• 3+ years small molecule DS/DP IND CMC and NDA writing.
• 3+ years project and lifecycle management experience in the Biotech industry.
• Experience in pharmaceutical development, including broad knowledge of the drug development process including industry best practices and FDA stage goals for stage I/II/III validation.
• Strong project management skills with experience utilizing PM tools.
• Strong, analytical, quantitative and creative problem-solving skills.

 

Additional Competencies

• Experience using Microsoft Office Applications (Word, Excel, Outlook)
• Comfortable using internet applications
• Comfortable navigating PC operating systems
• Excellent communication skills (oral and written)
• Ability to ask clear, goal-oriented questions
• Excellent attention to detail and problem-solving skills
• Self-motivated to complete tasks within agreed-upon deadline, ability to communicate clearly about deadlines and expectations
• Able to manage time well and ask for support when needed
• Quick learner, excited about learning to use systems in new contexts
• Able to support the following tools in multiple, pre-specified contexts. Prior experience a plus, some training will be provided: Smartsheet, Zoom, Asana

 

FLSA Status

Exempt (i.e. not eligible for overtime)

 

Compensation

Salary range disclosed upon request. Includes full benefits package.

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MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a 501(c)(3) non-profit research and educational organization.