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Senior CMC Regulatory Affairs Specialist
2 weeks ago
Pride Health is seeking a
Senior CMC Regulatory Affairs Specialist
for a company developing next-generation T-cell reprogramming technologies.
Job Title: Senior CMC Regulatory Affairs Specialist
Location: Seattle and Bothell, WA (Hybrid, Mondays and Thursdays on-site)
Job Type: Contract
Length: 6-Months
Hours: 40 hours/week
Pay Rate: $ $48.73 per hour
Responsibilities:
- Support preparation, review, and submission of CMC sections for U.S. and global regulatory filings, including INDs/CTAs, amendments, and BLAs/MAAs.
- Coordinate with internal stakeholders to gather technical information and ensure accuracy and consistency across CMC documentation.
- Assist in developing and maintaining submission plans for assigned programs.
- Review change controls and manufacturing documentation to assess regulatory impact.
- Track and interpret evolving regulatory requirements and guidance relevant to cell and gene therapy manufacturing, testing, and control.
- Support interactions with domestic and global health authorities, including preparation of meeting materials, responses to information requests, and briefing documents.
- Maintain regulatory databases, document systems, and submission archives in compliance with internal procedures.
- Contribute to continuous improvement initiatives within the Regulatory Affairs CMC function.
Requirements:
- BA/BSc in a scientific field with a minimum of 5 years' experience; or MBA or MSc with a minimum of 2 years' experience
- 3 years of experience supporting Regulatory Affairs and/or CMC functions in the Biotechnology industry.
- Relevant experience with lentiviral vectors, cell and gene therapy process development and/or analytical method development.
- Understanding of FDA regulations, and ICH GCP guidelines.
- Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills.
- Excellent attention to detail and demonstrated project management skills.
- Ability to work independently and collaboratively among cross-functional teams.
- Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities.
Schedule Notes:
- Must be flexible to work from either the Seattle or Bothell site in WA. This is a hybrid position, candidates are required to be onsite Mondays and Thursdays at either one of those locations.
Benefits that Pride Health offers:
Pride Health offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.
Apply Today If you are interested in the position, please email your resume to for immediate consideration.
