Associate Director, Regulatory Affairs, CMC

Asklepios BioPharmaceutical, Inc. (AskBio)

2d

About The Position

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through. Position Summary The Associate Director, Regulatory Affairs, CMC is responsible for managing the regulatory CMC strategy and coordinating regulatory activities and logistics for all assigned projects. This role will ensure appropriate development and timely registration of gene therapy product candidates. Reporting to the Vice President, Regulatory Affairs CMC, the role will be responsible for the progression and submission of regulatory filings for gene therapy projects in the US and internationally. The individual will drive the preparation and submission of high‑quality CMC sections of briefing documents, IMPDs, GMOs, INDs, CTAs, and original marketing applications (BLAs/MAAs), in close collaboration with CMC, Quality, contract manufacturing organizations, and external consultants and collaborators. This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range disciplines with diverse regulatory requirements from novel gene therapy platforms in an evolving regulatory landscape. This position will report to the VP, Regulatory Affairs, CMC.

Requirements

• Bachelor’s degree in a scientific or engineering discipline and 8+ years of experience in CMC drug development (may include experience in Regulatory Affairs CMC, process/analytical development, GMP Quality Assurance, or MSAT)
• At least 3 years in a Regulatory Affairs CMC role
• Proven record of contributions to successful IND/CTA and NDA/BLA/MAA submissions and approvals
• Possess extensive experience compiling investigational submissions such as but not limited to US INDs, US IND amendments, Canadian CTA’s, IMPDs and other international submissions

Nice To Haves

• An advanced degree (MS, MD, PhD, PharmD) in a scientific or engineering discipline
• Excellent negotiation skills and demonstrated experience modeling positive communications, interpersonal, and relationship-building skills
• Experience in advanced therapeutic technologies (e.g., gene therapy, cell therapy) is strongly preferred
• Experience with Electronic Document Management Systems (e.g. Veeva)
• Deep and broad CMC knowledge of FDA, EMA, MHRA, PMDA, HC, etc. laws, regulations, directives, guidance and practices; preferred biologics or gene/cell therapy experience
• Enthusiasm and drive to lead special assignments that enhance AskBio’s excellence in gene therapy product development, registration, and commercialization
• Proficiency with MS Office products and applications commonly used in Regulatory Affairs

Responsibilities

• Support innovative, comprehensive regulatory CMC strategies and associated timelines for assigned projects to ensure timely global registration of Company’s product candidates in gene therapy
• Manage and implement planning, authoring and submission of high-quality CMC‑related sections of briefing documents and clinical trial applications in the US, EU and ROW
• Provide general operational support to RA CMC team across all programs, including submission management, regulatory project management, and Veeva technical support
• Prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections
• Drive adherence to CMC regulatory guidelines relevant for the development of gene therapy products; author, review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
• Support the development of regulatory processes and standards
• Ensure operational alignment and on-time completion of all registration-directed activities through close collaboration with Project Management colleagues and senior management.
• Partner with Quality Assurance colleagues to ensure regulatory compliance with applicable local and international laws and regulations, as well as industry standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees