Chemist-Regulatory Affairs Lead

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Job description

When you join Thermo Fisher Scientific, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and unique contributions. Our commitment to you and our 90,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building a fulfilling career with us.

How will you make an impact?

The Regulatory Affairs Lead (RAL) role will serve as Controlled Substance Program (CSP) and Regulatory Affairs specialist for the Ward Hill site. In this role, the RAL 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 DEA registrations to manufacture and distribute associated chemical products. Also, lead a small team in conducting customer screening, coordinating of import and export controls, and product releases according to governing site procedures, DEA, and TSCA regulatory requirements

What will you do?

• 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.
• Evaluating and approving/rejection of new chemical product introductions based on site's current regulatory registrations and restrictions.
• 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 enviornment,

Experience

• Strong Chemistry background enabling evaluation and approval of new product introductions against the site's applicable regulatory standards and registrations.
• Experience with Oracle, SAP, AS/400 ERP systems desirable

Knowledge, Skills, Abilities

• Ability to lead a small team of performing daily transactional work in support of regulatory requirements and ensure work is performed accurately and in a timely manner.
• 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 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.

Apply today!

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.

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