Associate Director, Regulatory CMC
About The Position
The Associate Director, Regulatory CMC will report to the Senior Director, Regulatory CMC and assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage preparation of dossiers in eCTD format. The Associate Director will have one or more direct reports, will work closely with cross-functional teams on CMC regulatory strategy and regional regulatory requirements, and will consult with CMC subject matter experts (SMEs). Key responsibilities will include the development of Health Authority submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc.
Requirements
- Bachelor’s Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required; or Master’s Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required.
- Experience in the management and preparation of the submission of CMC modules in eCTD format required
- Experience with organizing responses to Health Authority requests required
- Strong knowledge of Health Authority CMC guidance documents and requirements
- Good leadership skills with the ability to direct and develop professional staff
- Expert knowledge of Chemistry, Manufacturing and Controls of a medical product and related regulatory requirements and guidelines
- Ability to manage work and staff with firm deadlines and adapt quickly to changing requirements and priorities
- Excellent organizational skills, written and oral communication skills, and attention to detail
Nice To Haves
- Experience with regulatory submissions outside of the US preferred
- Experience managing staff preferred
- Expert knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred
Responsibilities
- Provide expert opinion on CMC topics planned or performed
- Manage the preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance and company standards
- Assist with the development of global CMC regulatory strategies
- Prepare or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation
- Provide expert opinion on CMC topics planned or performed
- Assist with the design of CMC protocols
- Collaborate with other groups when needed to address CMC related matters
- Prepare responses to Health Authority comments and questions pertaining to CMC issues
- Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications
- Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance
- Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities
Benefits
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
- We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
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What This Job Offers
Job Type
Full-time
Career Level
Director
