Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAs 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.DescriptionJoin our Regulatory Affairs team at Thermo Fisher Scientific, where you'll make a significant impact on global healthcare through cutting-edge solutions. As Director of Regulatory Affairs, you'll lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions. This key leadership role involves developing and implementing regulatory strategies, mentoring teams, and managing critical relationships with regulatory agencies worldwide.You'll oversee regulatory compliance activities, provide expert guidance on regulatory requirements, and ensure successful product submissions across various jurisdictions. Working closely with cross‐functional teams, you'll shape regulatory strategy for product development, manufacturing, and commercialization while maintaining the highest standards of compliance.



This role offers the opportunity to influence global regulatory policy and drive innovation in our regulatory approaches.RequirementsAdvanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical/medical device regulatory affairs with emphasis on manufacturing operationsPreferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or related fieldComprehensive knowledge of global regulatory requirements, particularly FDA, EMA, and ICH guidelinesSuccessful track record of regulatory submissions and agency interactionsLeadership experience managing and mentoring multi‐site teamsExperience in regulatory strategy development and implementationDemonstrated expertise in regulatory compliance and quality management systemsAdvanced project management and organizational skillsExcellent verbal and written communication abilitiesEffective negotiation and influencing skillsAbility to work effectively in a matrix organizationBusiness acumen and strategic thinking capabilitiesProficiency in standard office technology and regulatory systemsFluency in English required; additional language skills advantageousAbility to travel 25-50% of time, primarily internationalExperience with CDMO/pharmaceutical services preferredKnowledge of current industry trends and participation in professional associations (e.G., TOPRA, PDA)CompensationThe salary range estimated for this position based in Ohio is $150,000.00–$218,000.00.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.#J-18808-Ljbffr

📌 Director Ra Osd/Api - $150,000 - $218,000 A Year (Toronto)
🏢 Thermo Fisher Scientific
📍 Toronto