Sr. Regulatory Affairs Associate

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

St. Louis, MO

Pharma Services Group

How will you make an impact?

This role is a primary contact for Site Regulatory Affairs for a biological drug substance manufacturing facility. This includes regulatory assessment of the Critical Change Control process, site regulatory filing management/oversight, regulatory review of master batch records, and a regulatory point of contact for clients. This role will author sections for client biological molecule dossiers and provide strategic regulatory support for site project teams in partnership with Global Regulatory Affairs. 

Responsibilities

• Provide oversight to client regulatory submission strategies and timelines.
• Authoring, reviewing, and commenting for Chemistry Manufacturing and Control (CMC) CTD documents for biologics products, including Investigational Applications (IND, CTX), Marketing Applications (NDA, NDS, MAA, BLA), and post-approval lifecycle dossiers, gap analyses and responses to review questions per the Regulatory Affairs Services Menu.
• Collaborate and coordinate with technical experts to support the authoring and review activities of CMC CTD documents and draft regulatory strategic advice for internal customers and clients.
• Support the site inspection readiness program and client Pre-License Inspection activities from a regulatory perspective.
• Participate as a member of the Change Review Board.
• Provide interpretation and mentorship to site personnel with respect to current regulations that apply directly or indirectly to approved drug products.
• Provide knowledge of current cGMP requirements and trends through execution of regulatory intelligence surveillance and communication to the network.
• Oversee local regulatory filings and site master file.
• Field client regulatory requests and assist with client regulatory filing reviews.
• Provide structure and oversight for regulatory services work statements and client invoicing.
• Responsible for generation of Annual Product Review program for clients.
• Other responsibilities as needed to ensure the site’s compliance with FDA, EMA and other cGMP regulations, including client requirements.

Education

Bachelor’s degree in a scientific field (Life Sciences, Biotechnology, or equivalent) is required.

Experience

• Minimum of 5 years in a Quality role in a cGMP environment, biologics manufacturing preferred
• Minimum of 5 years regulatory experience in the biopharmaceutical industry

Knowledge, Skills, Abilities

• Self-starter who can carry out roles and responsibilities autonomously
• Well organized, detailed oriented, and strong time management skills with ability to multi-task in a fast-paced environment.
• Strong communication and presentation skills
• Proven understanding of the global regulatory environment for biotechnology products including in-depth knowledge of Health Authorities submission requirements.
• Ability to evaluate and resolve complex regulatory and technical issues due to extensive knowledge of biopharmaceutical manufacturing and related regulatory requirements in this product sector. Ability to interact and collaborate with all levels of the organization, clients, and vendors
• Ability to identify and facilitate change
• Sound skills in typical office electronic platforms.

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.