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 ulviprubart (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) and TLGLL, into clinical studies.
POSITION SUMMARY
Abcuro, Inc. is seeking a highly skilled Senior Director of Regulatory Chemistry Manufacturing & Controls (CMC) who is eager to be part of a growing company and a collaborative team with a goal to provide Regulatory CMC leadership. Reporting to the Vice President of Regulatory, this individual will play a pivotal role in CMC-focused Agency interactions, submission writing, and innovative CMC strategies that support Abcuro’s programs as we move from clinical to commercial stage. The position requires an individual who can provide global Regulatory CMC strategic guidance and tactical support to CMC teams with regard to regulatory requirements, regulatory interactions, and submissions for CMC activities for drug development, registration, and lifecycle management.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Actively represent Regulatory CMC and provide regulatory expertise as a member of multidisciplinary teams and with business partners such as CDMOs and consultants.
- Collaborate with cross-functional teams to generate and refine the product development strategy.
- Lead preparation of high-quality global clinical trial applications (INDs/CTAs) specific to CMC content, responses to agency questions, maintenance activities, and effective regulatory tracking.
- Lead preparation of high-quality license applications (BLA/MAA) specific to CMC content, responses to agency questions, and maintenance activities.
- Lead and coordinate regulatory CMC submissions, including assembling necessary cross functional teams and timelines relevant to assigned projects and programs.
- Actively contribute to the preparation and execution of global agency meetings, queries and inspections
- Work closely and creatively with technical teams to support the implementation of manufacturing and analytical development strategies that comply with applicable regulatory requirements and guidelines.
- Stay up to date with changes in global regulatory requirements and provide guidance on their impact on the organization
- Identify and clearly communicate regulatory CMC risks and mitigation to both the technical team and Regulatory teams.
- Develop and implement global strategies that maximize the probability of commercial launch success.
- Develop relevant policies and procedures for internal regulatory organization.
- Actively monitor regulatory policy and intelligence and disseminate information to inform the team and program strategy including the development of new requirements, guidelines and trends.
- Ensure compliance with company policies, industry laws and regulations, and ethical business practices.
EDUCATION AND WORK EXPERIENCE
- Advanced degree (Ph.D., Pharm.D., M.S., or equivalent) in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related discipline.
- At least 12 years of relevant experience in CMC Regulatory Affairs for biologics including experience with global filings and required maintenance. Experience with license applications (BLA, MAA) desired.
- Strong knowledge of current Good Manufacturing Practices (c(GMP), US, EU, and UK regulations/guidelines and ICH guidelines.
- Effective organization and prioritization skills to create and achieve established timelines.
- Proven ability to manage multiple projects and priorities in a fast-paced environment.
- Ability to work independently and with project teams, committees, to achieve group/corporate goals.
- Excellent communication and interpersonal skills for effective collaboration and regulatory authority interactions.
- Creative problem solving and strategizing abilities.
- Active participant in biotech/pharma trade groups a plus.
- Authorized to work in the U.S.
- Able to travel approximately 15%.
- In office or remote working environment offered.
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.
**Please direct all inquiries and/or CV submissions to careers@abcuro.com