Sr. Manager, Regulatory Affairs Cell and Gene Therapy

Overview

Thermo Fisher Scientific is an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule Standard (Mon-Fri)

Environmental Conditions Office

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. We enable our customers to make the world healthier, cleaner and safer by supporting global teams with the resources needed to achieve individual career goals and by developing solutions for the world’s toughest challenges, such as protecting the environment, ensuring food safety and helping to find cures for cancer.

Discover Impactful Work

As a Sr. Manager, Regulatory Affairs, you will interpret and disseminate global regulations, guidelines, and emerging industry developments that influence pharmaceutical product development. You will develop and align regulatory tools, including information systems, with strategic objectives, manage regulatory professionals, provide guidance to development teams, and ensure products meet all necessary requirements.

• Interpret and communicate the impact of 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.
• Provide regulatory expertise and support to business leadership.
• Develop regulatory strategies accounting for global requirements and 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 for reporting and communicating 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 and communicate a clear plan to motivate the team toward goals and defined success metrics.

Keys to Success:

• 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.
• 2-4 years of people management experience strongly preferred.

• Extensive knowledge of regulatory requirements, including FDA, Health Canada, and other regions, particularly concerning pharmaceutical raw materials and cell and gene therapies, and their impact on the product development process.
• Ability to evaluate 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 complex regulatory filings in relation to cell and gene therapies.
• Ability to navigate regulatory authorities’ requirements and effectively communicate to ensure timely and accurate submissions.
• Excellent communication skills for interactions with internal customers, regulatory authorities, and cross-functional teams.
• Advanced organizational and time management skills to prioritize and manage multiple complex projects.
• 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.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of…