Senior Scientist, Regulatory CMC
About The Position
The Senior Scientist, Regulatory CMC will assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage the preparation of dossiers in eCTD format. The Principal Scientist will interact with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and interact with CMC subject matter experts (SMEs). This position will support the development of 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 6+ years’ relevant progressive experience required; or Master’s Degree in life sciences or technical discipline with 4+ years’ relevant progressive experience required; or Doctorate degree in life sciences or technical discipline with 2+ years’ relevant progressive experience required.
- Experience in the preparation of the submission of CMC modules in eCTD format required
- Familiarity with organizing responses to Health Authority requests required
- Knowledge of Health Authority procedures and guidance regarding document management and electronic submission
- Knowledge of Health Authority CMC guidance documents and requirements
- Proficient in Electronic Document Management Systems
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Strong organizational skills, written and oral communication skills, and attention to detail
Nice To Haves
- Familiarity with regulatory submissions outside of the US a bonus
- Knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins desired
Responsibilities
- Prepare and review Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards.
- Support the development of global CMC regulatory strategies.
- Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation.
- Provide input and recommendations on CMC topics planned or performed.
- Support the design of CMC protocols.
- Interact with other groups when needed to address CMC related matters.
- Assist with the preparation of responses to Health Authority comments and questions pertaining to CMC issues.
- May train others on Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications as appropriate.
- 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
Mid Level
