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Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description The Sr. Manager, Regulatory Affairs - Drug Support Strategy is a new role responsible for providing strategic regulatory leadership for pharmaceutical ancillary materials and excipients. This position will effectively collaborate with and lead all aspects of professionals in regulatory affairs to develop detailed drug support strategies, ensuring the safe and compliant handling of ancillary materials used in pharmaceutical applications. This Regulatory leader will work closely with cross-functional teams to execute company priorities and partner with the Leadership Team to drive initiatives that are closely aligned with global strategies, as well as customer and employee needs. The Sr. Manager will develop and pursue world-class regulatory support and assure compliance in the pharmaceutical space. Location: This is a remote position available for hire in the USA or Scotland. Residency in the US or Scotland required. No relocation assistance will be provided. Job Responsibilities A day in the Life: Interpret and communicate impact of relevant global regulations, guidelines and evolving regulatory trends. Assessment of product changes and impact for on-market products as well as ensure ex-US registrations are planned and completed in accordance with business need. Develop and implement comprehensive drug support strategies for ancillary materials and off-label excipients used in pharmaceutical applications Lead regulatory affairs talent passionate about supporting customer drug filings and CMC documentation Support customer due diligence processes and handle regulatory documentation requests Serve as the special point of contact for marketing, sales, and training teams in the drug space Establish and maintain regulatory demands related to pharmaceutical ancillary materials, ensuring compliance with internal policies, customer expectations, and regulatory standards Provide strategic mentorship on applicable CMC regulatory submissions and support for customers using our materials in their drug products Ensure that regulatory solutions implemented are scalable, flexible, and consistent in all regions whenever possible Coordinate with global counterparts and communicate global impact of proposed changes Develop training programs for internal teams on pharmaceutical regulatory requirements and customer needs Lead cross-functional initiatives to harmonize processes and systems for supporting pharmaceutical customers Keys to Success: Experience Bachelor's Degree in Pharmaceutical Sciences, Chemistry, or related field; advanced degree preferred 7 years of experience in CMC regulatory affairs within the pharmaceutical industry 1+ year of prior experience leading a successful team of direct reports. Strong background in pharmaceutical regulatory operations, with the ability to lead improvements in policies and procedures Experience in Operations a plus Experience in Excipient Manufacturing a plus Knowledge, Skills, Abilities Industry-related knowledge – Guidelines and policies for pharmaceutical excipients and ancillary materials within Regulatory Affairs Extensive knowledge of ICH guidelines, particularly those related to pharmaceutical development, manufacturing, and quality Understanding of business processes – Regulatory Affairs systems Physical Requirements / Work Environment Regular interaction with cross-functional teams, such as Research and Development, Product Management, Marketing, Quality Assurance, and Manufacturing. Interaction with Regulatory authorities. 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 New York is $118,000.00–$157,000.00. 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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.