Thermo Fisher Scientific · 1 day ago
Sr. Manager, Regulatory Affairs Cell and Gene Therapy
Cranbury, NJ
Full-time
Onsite
Senior Level, Lead/Staff
$130K/yr - $190K/yr
8+ years expThermo Fisher Scientific is an innovative organization dedicated to making a positive impact on a global scale. As a Sr. Manager in Regulatory Affairs, you will interpret and communicate global regulations and provide regulatory expertise to ensure compliance in pharmaceutical product development, specifically in cell and gene therapy.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Interpret and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area of cell and gene therapy
Lead maintenance and improvements to regulatory tools, including regulatory information systems to meet organizational objectives
Provide regulatory expertise and support to business leadership
Develop regulatory strategies accounting for global requirements and desired marketing claims
Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other regulatory bodies
Provide regulatory direction to product development teams
Lead all aspects of regulatory compliance of advertising and promotional materials
Supervise compliance with license registration, listing, and renewal requirements
Provide leadership and guidance for the reporting and communicating of product-associated complaints, recalls, market withdrawals, and vigilance reports as applicable
Direct the process for evaluating and processing product change requests including impact assessment
Propose innovative regulatory options for new products or claims
Manage departmental budget
Determine work priorities aligned with business, functional, and company goals
Lead a team of regulatory professionals
Communicate a clear plan and motivate the team to achieve goals and defined success metrics
Qualification
Required
Bachelor's degree in life sciences, pharmacy, or related field required
Minimum of 8 years related experience in the pharmaceutical or life sciences industry or an advanced degree with 6 years related experience
Extensive knowledge of regulatory requirements, including those from the FDA, Health Canada, and other regions, particularly concerning pharmaceutical raw materials and cell and gene therapies, and their influence on the product development process
Ability to evaluate and analyze potential regulatory impact on new and existing products and provide strategic recommendations to minimize risks and ensure compliance
Extensive experience in compiling and submitting regulatory filings with a track record of leading successful complex regulatory filings in relation to cell and gene therapies
Demonstrated ability to navigate regulatory authorities' requirements and effectively communicate with them to ensure timely and accurate submissions
Excellent communication skills to effectively interact with internal customers, regulatory authorities, and cross-functional teams
Advanced organizational and time management skills to efficiently prioritize and manage multiple complex projects simultaneously
Seasoned people leader who creates a positive workplace that promotes teamwork, collaboration, and innovation
Regular interaction with cross-functional teams, such as Research and Development, Product Management, Marketing, Quality Assurance, Manufacturing and with Regulatory authorities
Preferred
2-4 years of people management experience strongly preferred
Benefits
Competitive remuneration
Annual incentive plan bonus
Healthcare
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO)
10 paid holidays annually
Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
Accident and life insurance
Short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
EIN Presswire
2026-01-05
Crunchbase News
2025-12-31
2025-12-25
Company data provided by crunchbase