Thermo Fisher Scientific Regulatory Specialist, Clinical Ancillary Materials in Remote / Field, Pennsylvania
When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. http://www.fisherclinicalservices.com/
How will you make an impact?
The role of Regulatory Specialist, Clinical Ancillary Materials has a primary responsibility to ensure proper compliance of sourcing and distribution plans for ancillary products for global clinical trials. The Regulatory Specialist will collaborate with Sales, Solutions, Clinical Supply Chain Managers, Sourcing, and Quotations teams to thoroughly understand product and country requirements for effective strategic planning. This role will ensure seamless, on-time delivery of ancillary supplies to all clinical sites for the life of each clinical trial.
What will you do?
Apply knowledge of regulatory requirements for successful project planning and execution in alignment with client request and company policy, procedure, etc.
Ensure regulatory compliance of procurement/distribution plans for all products and countries by project
Meet all regulatory milestones per agreed timeline and strategy
Define documentation requirements for inventory receipt and import/export (Certificate of Compliance, BSE/TSE statements, MSDS, etc.)
Identify areas of risk to project plans by product, region (or both) and recommend remediation or alternate plans for successful global delivery
Act as primary contact for all regulatory queries
Coordinate the collection and determination of Harmonized Tariff Schedule codes, Country of Origin, Export Control Classification Numbers, and regulatory information from suppliers and clients
Create a regulatory audit program and assistance with Global Trade Compliance (GTC) audits
Manage activity, planning, and requests as needed with GTC, disseminate updates to matrix teams accordingly
Participate in internal or external project audits as required
Gain comprehensive understanding of global and local regulations to allow creation of comprehensive/seamless procurement and distribution plans
Manage communication with regulatory agencies and other relevant entities for query handling, escalation, etc.
Manage regular cadence with matrix teams to ensure proper alignment of plans (sales, Solutions, Clinical Supply Chain Managers, etc.)
Prepare training materials and share best practices in the regulatory arena
Apply Good Manufacturing Principles (GMP) in all areas of responsibility
Demonstrate and promote the company vision
How will you get here?
- BS/BA in business or the sciences
5-7 years of experience in a regulatory role, ideally in the pharmaceutical industry
Experience leading complex projects across organizations
Ability to work with a sense of urgency in a fast-paced environment
Superior analytical, problem solving and decision-making skills
Experience working with remote teams spanning the globe
Proficiency in personal computer applications: SharePoint, Microsoft Word, Excel, PowerPoint, Outlook).
Ability to travel at least 15% of the time
Any specialized education with a regulatory focus such as a degree or certification in Regulatory Affairs, accredited member of professional group, etc.
Knowledge of global regulatory requirements for clinical trials
Experience with regulations which govern use of commercial products in clinical trials
Knowledge of Pharmaceutical and/or medical device products and services
Ability to effectively navigate regulatory landscape, including identifying proper contacts and agencies for consultation/feedback
Excellent written and oral communication skills
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.
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.