[Hiring] Associate Director, Regulatory Affairs, CMC @Asklepios BioPharmaceutical, Inc. (AskBio)

Role Description 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. This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of disciplines with diverse regulatory requirements from novel gene therapy platforms in an evolving regulatory landscape.

• 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.

Qualifications

• 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.

Requirements

• 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.

Company Description

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at [email protected]. Apply tot his job Apply To this Job