Job Title

The Chemist-Regulatory Affairs role will serve as Controlled Substance Program (CSP) and Regulatory Affairs specialist for the Ward Hill site. In this role, the Chemist will play a meaningful role to ensure the site meets all requirements related to the Thermo Fisher Scientific Corporate CSP Policy and is always in a state of inspection readiness. Activities include maintaining required regulatory controls for the sale and distribution of regulated chemical products. Also, lead a small team in conducting customer screening for sales, coordinating of import and export controls, and product releases according to governing site procedures and regulatory agency requirements. What will you do?• Evaluating and approving/rejecting new chemical product introductions based on site's current regulatory registrations/licenses and restrictions.• Apply chemical knowledge to vet customer sales to ensure alignment with Research Use Only (RUO) intended use of regulated chemical products. • Maintaining a deep understanding of new and existing regulations that may impact the organization's products and processes including but not limited to DEA, DOT, TSCA, Health Canada, and California State Regulations.• Maintaining data and files for future reference, particularly in the event of an inspection by a regulatory agency or internal audit.• Lead a small team of QA/RA team performing daily transactional work. Including controlled substance import and export processes, supplier and customer vetting, and coordinating order hold and release activities.• Report suspicious order activities to the QA/RA leadership team and to the DEA if confirmed.• Approve and handle registered DEA List I/List II chemicals ensuring the ERP and support systems are maintained as current.• Provide expertise and training on governing regulatory procedures and regulatory transactional work for new QA/RA team hires.• Serve as lead for internal, corporate, and agency inspections in support of the Ward Hill team and the Controlled Substance Program.Essential Skills and Experience:How will you get here?• Bachelor's Degree in Chemistry and 3+ years in a Regulated GMP environment.Experience• Strong Chemistry background enabling evaluation and approval of new product introductions against the site's applicable regulatory restrictions and customer intended use (RUO).• Experience with Oracle, SAP, AS/400 ERP systems desirableKnowledge, Skills, Abilities• Ability to lead a small team performing daily transactional work in support of regulatory requirements and ensure work is performed accurately and in a timely manner.• Preferred knowledge of current DEA Controlled Substance and TSCA regulatory requirements for chemical compliance. Preferred but not required.• Must be computer savvy and skilled in Microsoft Office, including Excel and Teams software• Confident with handling smaller scope site project teams and improvement initiatives, ensuring clear communication, proper issue handling, and issue/solution-based approach• Strong understanding of GMP quality standards preferred.At Thermo Fisher Scientific, each one of our 90,000 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.Additional Sills: Skills: Category Name Required Importance Experience No items to display.