Senior Specialist, CMC Regulatory Affairs

Overview

Prepare and submit CMC sections for regulatory filings; coordinate data, ensure compliance.

Key Responsibilities

• submission plans
• regulatory tracking
• change review
• authority interaction
• database maintenance
• cmc submissions

Tasks

-Assist in developing and maintaining submission plans for assigned programs. -Contribute to continuous improvement initiatives within the Regulatory Affairs CMC function. -Track and interpret evolving regulatory requirements and guidance relevant to cell and gene therapy manufacturing, testing, and control. -Review change controls and manufacturing documentation to assess regulatory impact. -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. -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.

Requirements

• mba
• msc
• regulatory
• gene therapy
• fda
• project management

What You Bring

-Ability to work independently and collaboratively among cross-functional teams. -3 years of experience supporting Regulatory Affairs and/or CMC functions in the Biotechnology industry. -MBA or MSc with a minimum of 2 years’ experience -Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities. -Excellent attention to detail and demonstrated project management skills. -BA/BSc in a scientific field with a minimum of 5 years’ experience; or -Relevant experience with lentiviral vectors, cell and gene therapy process development and/or analytical method development. -Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills. -Understanding of FDA regulations, and ICH GCP guidelines.

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Benefits

-Employee Assistance Program -Short and long-term disability -Time Off/Leave (PTO, Vacation or Sick Leave) -Medical, dental & vision -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Critical Illness, Accident, and Hospital -Health Spending Account (HSA) -Transportation benefits -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms