[Remote] Sr. Manager, Regulatory Affairs Cell and Gene Therapy

Note: The job is a remote job and is open to candidates in USA. Thermo 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.

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.

Skills

• 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.
• 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 Overview

• Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services. It was founded in 1956, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 10001+ employees. Its website is https://www.thermofisher.com.

Company H1B Sponsorship

• Thermo Fisher Scientific has a track record of offering H1B sponsorships, with 186 in 2025, 224 in 2024, 233 in 2023, 342 in 2022, 315 in 2021, 227 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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