Director of Regulatory Chemistry Manufacturing and Controls

1 month ago

Waltham, Massachusetts, United States Mythic Therapeutics Full time
Job Summary

Mythic Therapeutics is seeking a highly experienced Director/Senior Director of Regulatory Chemistry Manufacturing and Controls (CMC) to join our growing Regulatory Affairs team. This role will report to the Vice President Regulatory Affairs and will closely collaborate with Technical Operations, Quality, Clinical Operations, and other functions to provide direction on the application and interpretation of global CMC regulations to support the overall project goals.

Key Responsibilities
  • Develop and implement robust CMC regulatory strategies for all development programs, anticipating phase-appropriate and future commercial requirements in close collaboration with Technical Operations and Quality colleagues.
  • Oversee the planning, preparation, and submission of high-quality regulatory CMC dossiers based on prior knowledge and current environment of the GTx landscape.
  • Provide CMC guidance to internal teams and lead cross-functional teams to prepare Module 3 and 2.3 sections for INDs and equivalent IMPD sections for CTAs.
  • Keep abreast of global CMC regulatory requirements and ensure that management, project team colleagues, and partners are informed of current regulations, regulatory guidance, and guidelines, and development risks and opportunities that may impact regulatory success for Mythic pipeline products.
  • Serve as a Regulatory CMC Lead on relevant cross-functional or functional teams that require experienced interpretation of applicable FDA/EMA/ICH/WHO/Global regulations to ensure CMC compliance.
  • Lead team members to establish CMC content (data and documentation) requirements for regulatory submissions and lead reviews of content for conformance with established requirements.
  • Assess the regulatory impact of proposed manufacturing process changes.
  • Track regulatory CMC commitments; manage ongoing regulatory submissions and future reporting requirements, including annual reports.
  • Accountable for the management and delivery of all CMC regulatory milestones, such as those related to global investigational drug filings (e.g., IND CTA) registrational filings (e.g., BLA NDS MAA) and responses to health authority questions/requests.
  • Support Quality and CMC team during GMP inspections.
  • Lead CMC-related interactions with the health authorities, including planning for related activities, managing preparation of meeting requests and briefing documents, and contingency plans, and preparing responses to preliminary comments.
  • Review and approve technical documentation, including technology transfer protocols, validation protocols, technical reports, manufacturing, and labeling information, to assure conformance with regulations and regulatory guidelines.
  • Represent Regulatory Affairs on CMC due diligence teams as required.
Qualifications and Experience
  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred, with a minimum of 8-10 years of demonstrated track record of exceptional regulatory product development experience.
  • Experience in the development of Antibody Drug Conjugates.
  • This position requires a thorough knowledge of CMC-related global regulatory guidance and guidelines, GMP requirements, and an understanding of clinical ICH Good Clinical Practice Guidelines.
  • Proven experience in critically reviewing detailed CMC-related scientific data, analyses, information, study reports, and documents, and providing assessment of technical arguments and conclusions based on the data and analyses.
  • Demonstrated ability to generate innovative solutions to complex regulatory problems and explain complex information in a concise and clear manner.
  • Demonstrated track record for successful interactions with FDA and other global health authorities on CMC topics. Ability to collaborate and communicate in an open, clear, complete, timely, and consistent manner.
  • Skilled in planning, organizing, prioritizing, and leading assigned regulatory activities in an efficient and high-quality manner.
  • Must have demonstrated experience in preparing and leading CMC documentation for regulatory filings (INDs, CTAs, etc.).
  • Able to view issues from multiple functional perspectives. Ability to work collaboratively and cross-functionally with research and development, technical operations, and clinical is critical to success in this role.
Personal Characteristics and Cultural Fit
  • Good judgement: Strong problem-solving, critical thinking, and analytical skills required to make evidence-based decisions. Good judgment, level-headed, neutral, and objective.
  • Builds Relationships and Culture: Reputation for creating strong team cultures of quality, trust, and collaboration. Skilled at building and managing relationships cross-functionally and with external collaborators/partners, consultants, and vendors.
  • Influences: Highly credible with various stakeholder groups (internal employees up-down and across the organization, external collaborators, partners, and vendors, and with site teams and investigators). Skilled at building and cultivating stakeholder confidence.
  • Execution mindset: Self-starter with a can-do mindset and do what is needed to advance the company's programs and initiatives. Drives self, individual, and team accountability, develops and implements goals, objectives, measurable targets, and processes to achieve results.
  • Demonstrated ability to work in a fast-paced, innovative biotech environment.

Mythic Therapeutics offers a fast-paced, entrepreneurial team-focused work environment. We also offer a top-notch benefits package and work/life integration. Being part of the Mythic team allows you to become part of a small team that supports professional development while working together to meet the company goals.

Mythic Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status, or any other basis protected by applicable law. Mythic does not accept unsolicited resumes from any source other than directly from candidates.

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