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Director, CMC Regulatory

Acumen Pharmaceuticals

Acumen Pharmaceuticals

Legal
Newton, MA, USA
Posted on Wednesday, July 3, 2024

Location

Greater Boston area

Role Description

Acumen Pharmaceuticals is seeking a Director, CMC Regulatory, reporting to the Vice President, Regulatory Affairs, to lead the development, implementation, and execution of CMC regulatory strategy, including global submission strategy for investigational applications, clinical trial support, compliance, marketing application strategy, and CMC change management, ensuring compliance with global regulations (e.g., FDA, EMA, MHRA, HC, PMDA, CFDA, ANVISA). This includes overseeing and coordinating product submissions for regulatory agency clearance and approval, providing input into clinical studies used to support product submissions, and contributing to regulatory agency inspections.

Responsibilities

  • Partners with regulatory colleagues to oversee the planning, preparation, and submission and contributes to the authoring of high-quality CMC regulatory documents, including INDs, amendments, clinical trial applications, BLAs, NDAs, MAAs, and variations/supplements, while meeting strict timelines and regulatory requirements.
  • Proactively identifies potential CMC program regulatory and/or submission risks and implements appropriate regulatory mitigation strategies to support the development plan, submissions, and lifecycle management.
  • Stays updated on evolving CMC regulatory guidelines and provides guidance and interpretation of CMC regulatory requirements, regulatory intelligence and benchmark information to Acumen teams and senior management, ensuring integration of CMC regulatory considerations into product development plans.
  • Collaborates cross-functionally with Quality, CMC, broader program teams and CMC vendors to ensure product development processes align with regulatory requirements.
  • Contributes to interactions with regulatory authorities and participates in meetings and negotiations regarding CMC.
  • Manages technical assessments of CMC source documentation and responses to technical questions on document content.
  • Provides CMC regulatory support and review for new and ongoing clinical trials (e.g., clinical trial applications and import licenses, clinical protocols, investigator brochures, labels, and other study-related materials) and for cGMP activities as they relate to regulatory affairs (e.g., inspections).
  • Provides regulatory oversight and guidance for primary and secondary packaging and labeling as it relates to clinical trial material and commercial products, as applicable.
  • Assists in the development and implementation of regulatory policies, procedures, and best practices to ensure consistent and compliant approaches.
  • Participates in due diligence audits and document reviews.

Qualifications

  • B.S./B.A required; advanced degree preferred (M.S., Ph.D., or equivalent) in a relevant scientific discipline.
  • Extensive experience (15+ years) in regulatory affairs within the biopharmaceutical industry. Biologics (large molecule) and drug-device combination experience is preferable.
  • Expert knowledge of global registration requirements, ICH regulations, safety requirements, regulations for drug products including experience with IND, NDA, CTA, and MAA submissions.
  • Demonstrated track record of successful regulatory submissions and interactions with regulatory agencies.

Compensation and Benefits

Competitive base salary, eligibility for an annual incentive bonus and eligibility to participate in company stock option plan. Competitive benefits package including health, dental, vision, life insurance, short and long-term disability, 401(k) and paid time off.

About Acumen Pharmaceuticals

Acumen, headquartered in Newton, MA, with offices in Indianapolis, IN and Charlottesville, VA, is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs. Acumen is currently conducting the ALTITUDE-AD study, a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial currently enrolling at sites in the United States and Canada, with plans for additional study centers in Europe and the UK, following positive results in INTERCEPT-AD, a Phase 1 clinical trial involving early Alzheimer’s disease patients.

Equal Employment Opportunity

Acumen Pharmaceuticals provides equal employment opportunities to all employees and applicants without regard to race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, childbirth, (or related medical conditions, including, but not limited to lactation), physical disability, mental and/or intellectual disability, age, military status or status as a Vietnam-era or special disabled veteran, marital status, registered domestic partner or civil union status, gender (including sex stereotyping and gender identity or expression), medical condition (including, but not limited to, cancer related or HIV/AIDS related), genetic information, sexual orientation or any other characteristic protected by applicable federal, state and local law.

Accommodation Of Disabilities

Acumen Pharmaceuticals is committed to providing reasonable accommodation for qualified applicants and employees with a disability (including veterans with a disability), unless such accommodation would cause an undue hardship.