Abcuro, Inc. is a clinical-stage biotechnology company developing protein-based treatments for serious autoimmune and cancer indications modulated by cytotoxic T and NK cells that express the inhibitory immune checkpoint receptor KLRG1 (killer cell lectin-like receptor G1). The company is advancing ABC008, a first-in-class anti-KLRG1 antibody designed to deplete cytotoxic T cells that attack healthy muscle tissue in patients with inclusion body myositis (IBM), into clinical studies.
POSITION SUMMARY
Abcuro Inc. is seeking a Director, Regulatory Affairs. This position will report to the Vice President, Regulatory Affairs. The position oversees that appropriate regulatory strategies are provided for the molecules in development, interpreting complex regulations, manages regulatory submissions, and actively engages with regulatory authorities to successfully submit and gain approval for new products, while maintaining ongoing compliance across the product portfolio.
The Director, Regulatory Affairs provides regulatory expertise to development teams on clinical and nonclinical regulatory strategies to achieve business objectives and manage the process from development of regulatory strategies through to approval. He/she serves a lead role for assigned projects and a supportive role for all of Abcuro’s development-stage products. Additional responsibilities include planning and leading major submissions such as IND, CTA, and responses to regulatory authorities related to IND/BLA submissions or international equivalents. Work efficiently with the cross functional team and medical writers in the development of Annual Reports, DSURs, Investigator’s Brochures, IND amendments and coordinate timely submission with regulatory operations. Serve as thought partner and lead the development of health authority briefing documents, as assigned. The position also supports management with the development and implementation of departmental strategies and policies as well as interpreting regulatory intelligence for internal teams.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Work with Regulatory management to develop and manage regulatory strategy for assigned projects in all stages of development (IND through approval and life-cycle management)
- Act as a direct liaison with regulatory authorities, as assigned. Respond to requests from regulatory authorities.
- Manage the preparation, including writing as necessary, review, and timely submission of all components of regulatory submissions including INDs and amendments, BLAs and supplements, annual reports, safety reports, etc.
- Participate as an active team member in regulatory sub-teams and serve as the Regulatory lead on Clinical Study Teams
- Plan and implement regulatory activities to maintain active INDs/CTAs (amendments and annual reports)
- Participate in the review of critical documents such as: protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA).
- Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation.
- Remain current on Regulatory Intelligence, new guidance documents and competitor information and provide fully informed information to teams and development programs
- Provide regulatory guidance and support to project teams including regulatory filing strategies, and support RA staff in filing process.
- Develop regulatory processes and procedures as needed.
EDUCATION AND WORK EXPERIENCE
- Bachelor’s degree in science of Life Science or equivalent.
- 6-8 years Regulatory Affairs experience planning and preparing submissions for drugs and biologics with IND, CTA, NDA and/or BLA.
- Proficiency in writing and editing technical regulatory documents including briefing documents for Health Authorities.
- Proven leadership skills with ability to manage projects and teams. Must be able to work independently and multitask in a timeline driven start-up environment.
- Strong knowledge of US and European regulatory processes and relevant knowledge of regulatory frameworks (e.g., FDA, EMA, ICH) and relevant regulations
- Excellent communication and negotiation skills to interact with regulatory authorities and internal stakeholders. Must be able to communicate clearly, succinctly and effectively with the cross-functional team and Regulatory Agencies. Strong interpersonal skills.
- Remote or hybrid working environment offer
- Travel as needed based on business requirements
If interested in this role, please email your resume to careers@abcuro.com.
Abcuro believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of any legally protected status. Abcuro will provide reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.