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.
Abcuro Inc. is seeking a Senior Manager of Regulatory Affairs. Reporting to the Vice President, Head of Regulatory Affairs, the Senior Manager provides regulatory expertise to development teams on clinical and nonclinical regulatory strategies to achieve business objectives. He/she serves a supportive role for all of Abcuro’s development-stage products. Additional responsibilities include support of study management teams and contributing to major submissions and responses to regulatory authorities related to IND/BLA submissions or international equivalents, Annual Reports, DSURs, Clinical Protocols, Investigator’s Brochures, IND amendments and Meeting Information Documents as required. The Senior Manager also supports management with the development and implementation of departmental strategies and policies as well as interpreting regulatory intelligence for internal teams.
- Work with Regulatory management to develop and manage regulatory strategy for assigned projects in all stages of development (pre-IND/pre-CTA through approval and life-cycle management)
- Manage the preparation, including writing as necessary, assembly review, and timely submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs 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
- Review investigator packages and authorize drug shipments to clinical sites
- Independently prepare submission documents for IND submissions (cover letters, forms, IND annual reports, IB annual updates)
- 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 competitive information in order to provide fully informed information to teams and development programs
- Support or lead non-project activities, as needed (i.e. SOP/standards development, organizational initiatives) for regulatory compliance
Education & Experience:
- Bachelor’s degree in Life Sciences with RAC certification desired
- Minimum of 8 years’ experience working in the biotech or pharmaceutical industry with minimum 3-4 years of related experience in Regulatory Affairs
- Excellent written and verbal communication skills
- Excellent organizational and project management skills; demonstrated ability to think strategically, proactively identify issues & prioritize multiple projects
- Knowledge and experience in the preparation of major regulatory submissions e.g., INDs, CTAs, Annual Reports, Safety Reporting, etc.
- Strong interpersonal skills and the ability to deal effectively with a variety of colleagues from various technical functions, including clinical, scientific, technical operations, CROs & external consultants
- Understanding of current US and global regulations and experience in interpretation of guidelines with requisite technical system skills to support global submissions
- Able to handle changing priorities and multidisciplinary tasks
- Easily gains trust and support of peers; encourages collaboration
- Demonstrated success as a member of cross functional teams
- Remote or hybrid working environment offered
- Travel as needed based on business requirements
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 make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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