Repare Therapeutics, Inc.
Director, Regulatory Affairs
Repare Therapeutics, Inc., Cambridge, Massachusetts, us, 02140
Repare Therapeutics - Cambridge, MA, 101 Main St, Cambridge, Massachusetts, United States of AmericaThursday, October 24, 2024Repare Therapeutics (Nasdaq: RPTX) is a leading clinical-stage precision oncology company enabled by our proprietary synthetic lethality approach to discovering and developing novel therapeutics. We use our genome-wide, CRISPR-enabled SNIPRx platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair.Our company was founded in 2016 by field-leading academics to systematically employ synthetic lethality insights and platforms and develop new precision oncology medicines.Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.About the Role:
The
Director of Regulatory Affairs
will work with the
Head of Regulatory Affairs
and senior leadership, to manage regulatory affairs deliverables across the company, including support and implementation of global regulatory strategy for development and preclinical pipeline. This individual will work closely with internal and external team members, serving as a point of contact for health authorities and providing regulatory guidance and partnership across all functions. This person will be expected to independently execute critical tasks and provide regulatory expertise and leadership within the organization.Responsibilities:
Serve as the regulatory lead for Repare’s development and preclinical pipeline including the development and implementation of innovative, science-based regulatory strategies highlighting key risks and mitigation measures while staying abreast of regulatory requirements and policies.Collaborate cross-functionally with Repare departments, operating as the regulatory subject matter expert within team meetings, preparing and submitting regulatory filings, leading regulatory agency meetings, developing policies and procedures, and building appropriate-sized internal resources / managing external resources to achieve broader corporate objectives.Lead regulatory dossier submissions to global and/or FDA utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions.Author regulatory documents (e.g., INDs, briefing book content, etc.) and develop effective working relationships with health authorities related to the company’s programs.Anticipate and interpret key regulatory trends and changes in the global/US regulatory environment and provide strategic guidance regarding development plans to drive successful advancement of programs safely and effectively through the clinic and development.Operate as an active and critical member in development and CMC team meetings representing the regulatory function and expertise.Identify and implement regulatory initiatives (i.e. Orphan Drug Designation, Fast Track Designation, Breakthrough Designation, etc.) to facilitate and expedite patient access to products.Perform other functions and duties as directed by the
Head of Regulatory Affairs .Requirements:
Bachelor’s degree in life sciences or health-related field; advanced scientific degree preferred (MS, PharmD, PhD, etc.).Experience in oncology drug development essential.8+ years global regulatory affairs experience with track record of advancing early-phase development programs, interacting with global health authorities to successful pre-IND, IND, CTA, and NDA/MAA submission, and demonstrated innovation and flexibility within a rapidly changing environment.Strong knowledge of current regulatory requirements and ability to develop integrated global regulatory strategies to support nonclinical and clinical development programs, as well as managing relevant timelines.Effective collaborator who can bring together multiple stakeholders and able to build positive relationships, with both internal and external partners.Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams.Demonstrated ability to navigate, problem-solve, execute, and lead in a dynamic environment.Demonstrated leadership experience in regulatory affairs.All-rounder profile with specific experience in managing submissions encompassing all areas of regulatory affairs (CMC, Clinical, Non Clinical).Repare Therapeutics is an equal opportunity employer committed to non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, gender identity, pregnancy, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Accommodations are available on request for candidates taking part in all aspects of the selection process. We appreciate your interest in working for Repare Therapeutics and look forward to connecting with you.
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The
Director of Regulatory Affairs
will work with the
Head of Regulatory Affairs
and senior leadership, to manage regulatory affairs deliverables across the company, including support and implementation of global regulatory strategy for development and preclinical pipeline. This individual will work closely with internal and external team members, serving as a point of contact for health authorities and providing regulatory guidance and partnership across all functions. This person will be expected to independently execute critical tasks and provide regulatory expertise and leadership within the organization.Responsibilities:
Serve as the regulatory lead for Repare’s development and preclinical pipeline including the development and implementation of innovative, science-based regulatory strategies highlighting key risks and mitigation measures while staying abreast of regulatory requirements and policies.Collaborate cross-functionally with Repare departments, operating as the regulatory subject matter expert within team meetings, preparing and submitting regulatory filings, leading regulatory agency meetings, developing policies and procedures, and building appropriate-sized internal resources / managing external resources to achieve broader corporate objectives.Lead regulatory dossier submissions to global and/or FDA utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions.Author regulatory documents (e.g., INDs, briefing book content, etc.) and develop effective working relationships with health authorities related to the company’s programs.Anticipate and interpret key regulatory trends and changes in the global/US regulatory environment and provide strategic guidance regarding development plans to drive successful advancement of programs safely and effectively through the clinic and development.Operate as an active and critical member in development and CMC team meetings representing the regulatory function and expertise.Identify and implement regulatory initiatives (i.e. Orphan Drug Designation, Fast Track Designation, Breakthrough Designation, etc.) to facilitate and expedite patient access to products.Perform other functions and duties as directed by the
Head of Regulatory Affairs .Requirements:
Bachelor’s degree in life sciences or health-related field; advanced scientific degree preferred (MS, PharmD, PhD, etc.).Experience in oncology drug development essential.8+ years global regulatory affairs experience with track record of advancing early-phase development programs, interacting with global health authorities to successful pre-IND, IND, CTA, and NDA/MAA submission, and demonstrated innovation and flexibility within a rapidly changing environment.Strong knowledge of current regulatory requirements and ability to develop integrated global regulatory strategies to support nonclinical and clinical development programs, as well as managing relevant timelines.Effective collaborator who can bring together multiple stakeholders and able to build positive relationships, with both internal and external partners.Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams.Demonstrated ability to navigate, problem-solve, execute, and lead in a dynamic environment.Demonstrated leadership experience in regulatory affairs.All-rounder profile with specific experience in managing submissions encompassing all areas of regulatory affairs (CMC, Clinical, Non Clinical).Repare Therapeutics is an equal opportunity employer committed to non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, gender identity, pregnancy, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Accommodations are available on request for candidates taking part in all aspects of the selection process. We appreciate your interest in working for Repare Therapeutics and look forward to connecting with you.
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