Repare Therapeutics is a 2017 “Fierce 15” drug discovery company backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com). Repare develops novel, precision oncology drugs that target specific vulnerabilities of tumor cells. This is accomplished by combining a proprietary, high throughput, CRISPR‐enabled drug target discovery platform with an experienced team of small molecule drug discovery scientists, structural and computational biologists. Founded by leading experts at the forefront of DNA damage and repair cancer biology and genome-scale synthetic lethal screening technologies, Repare has assembled a seasoned team of industry veterans and a world-class Advisory Board.
We are seeking a Director/Senior Director of Regulatory Affairs & QA at Repare that will oversee the global strategy and execution of the regulatory affairs objectives for the organization providing regulatory strategies for company’s regulatory applications at all stages of development. Ensuring that all activities within the organization are conducted according to the appropriate internal and external quality standards, and that there is adherence to all applicable regulatory requirements. Interfacing with Clinical to ensure studies are following global guidelines and establishing phase-appropriate RA/QA practices and procedures and overseeing their effective and efficient implementation.
Leading and promoting the organization’s philosophy in quality of development and services and in maintaining a work environment that fosters learning, open communication, collaboration, integration, and teamwork. This position will serve as lead for all aspects of Regulatory Affairs and Quality Assurance with emphasis on compliance with GMP, GLP and GCP requirements and standards. The Director/Senior Director will identify, recruit, and manage staff within Regulatory Affairs and external consultants as needed.
- Develops clinical and diagnostic regulatory strategies for all Repare programs in development.
- Coordinates, writes, compiles, as appropriate, document packages for regulatory submissions from development, manufacturing, preclinical and clinical areas per regulations/guidelines and company SOPs to support regulatory applications.
- Oversee the establishment, maintenance, and successful implementation of Regulatory & Quality processes and procedures.
- Develop, Lead, and manage a Regulatory function that complies with appropriate regulations and guidelines and demonstrates operational efficiency.
- Reviews and approves investigator site regulatory documents (i.e. investigator documents, Informed Consents, IRB/EC documents) according to US FDA requirements and/or country requirements for initiation of clinical sites and drug shipments.
- Ensure all interactions with Agency personnel (US/Ex-US) are conducted to the highest degree of professionalism.
- Establish credibility and confidence with key internal and external colleagues through regular communication and the highest degree of professionalism.
- Create effective team resource plans, structures and processes (including quality management) and institute appropriate SOPs.
- Lead and manage quality programs which instill personal accountability for accuracy, consistency, and completeness for all operations and departments.
- Manage key relationships and strategic discussion with large pharmaceutical partners, ensuring program advancement, quality discussions, and desirable outcomes.
- Ensure Company maintains audit-ready status and lead/support any investigations.
- Represent RA/QA, both staff and function, at the Repare Cross-functional Leadership Team (XLT) and R&D Leadership Team.
- Ensure that suppliers and external vendors meet all applicable requirements through the development, implementation, and execution of the Supplier Audit program.
- Develop and execute the RA/QA operating budget and manage department efforts to control costs.
- Minimum 10 years combined experience in Regulatory Affairs & Quality.
- Minimum 5 years of experience in regulatory oncology in a leadership capacity.
- Excellent working knowledge of US and EU regulations and guidelines.
- Successful regulatory filings associated with full life-cycle development: IND/NDA/MAA CTA, amendments, and experience with companion diagnostics are an absolute must.
- Minimum of a bachelor’s degree in a life science required. MS or PhD degree is preferred.
- Proven ability to find and create solutions for problems in an innovative way.
- Strong influencing skills and the ability to build strong interpersonal relationships.
- Superb oral and written communication skills with the proven ability to shape and frame to diverse audiences.
- Well-developed interpersonal and problem-solving skills with demonstrated leadership and organizational skills.