Sr. Manager, Regulatory Affairs Cell and Gene Therapy

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Discover Impactful Work As a Sr. Manager, Regulatory Affairs, you will play a crucial role in interpreting and disseminating global regulations, guidelines, and emerging industry developments that directly influence our business in pharmaceutical product development. Applying your expertise, you will actively contribute to continuously developing and aligning our regulatory tools, including information systems, with our strategic objectives. You will manage regulatory professionals, providing guidance and support to our development teams, ensuring that our products meet all necessary requirements. A Day in the Life: • 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. Keys to Success: Education: • Bachelor’s degree in life sciences, pharmacy, or related field required. Experience: • 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. Knowledge, Skills, Abilities: • 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. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Compensation and Benefits The salary range estimated for this position based in California is $130,000.00–$190,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: • 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, and 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 For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards Apply tot his job Apply To this Job