Regulatory Affairs Specialist III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

As 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.

Description

Join Thermo Fisher Scientific as a Regulatory Affairs Specialist III and contribute to ensuring compliance with global regulations while enabling our mission to make the world healthier, cleaner, and safer. You'll provide strategic regulatory guidance and expertise for product development, registration, and lifecycle management across our diverse portfolio. Collaborate with cross-functional teams to develop and implement regulatory strategies that enhance time-to-market while maintaining the highest standards of compliance. Serve as a key liaison with regulatory authorities, internal stakeholders, and external partners to achieve successful outcomes.

The Regulatory Specialist III will ensure our Cincinnati site follows the Drug Enforcement Administration regulations 21 CFR Part 1300 to End, site policies, and Thermo Fisher Scientific Corporate policies in support of all controlled substance activities at the site. This position requires good communication, critical thinking, and problem solving skills. The Regulatory Specialist Ill works closely with manufacturing, development, lab personnel, and many other areas of the business that handle controlled substances.

Key Responsibilities Include:

• Responsible to ensure compliance with Title 21 Code of Federal Regulations (Part 1300 to End) and corporate standard operating procedures regarding the manufacture, storage, and distribution of controlled substances through the completion of records and reports including DEA-222 Forms, ARCOS, Biennial Inventories, Quota Submissions, Computation Charts, and Year End Reports.
• Acts as the site Controlled Substance Product Coordinator and SME for the site Controlled Substance Program. Responsible for implementation, maintenance, and ongoing compliance of group level policies and/or Corporate Controlled Substance Program policies.
• Maintains knowledge of DEA regulations; monitors the Federal Register for changes in the regulations.
• Assists management with DEA inspections, internal audits, client audits, investigations, inquiries and ensures coordination and follow-up of any identified CAPA's and actions.
• Coordinates the receipt, storage, dispensing, shipment, and record keeping of controlled substances as it relates to Title 21 Code of Federal Regulations (Part 1300 to End).
• Preparation, maintenance, shipping, and ordering of DEA 222 forms.
• Facilitates the completion and submission of required DEA records and reports for controlled substances: ARCOS Reports, Year End Reports, Quota Submissions, and Import/Export submissions.
• Conducts periodic internal audits of various departments for continuous improvement and to ensure regulatory compliance with 21 CFR (Part 1300 - End).
• Builds or updates Standard Operating Procedures to reflect compliance with all necessary regulations.
• Develops and leads training programs related to DEA Compliance.
• Able to prioritize duties and lead multiple projects, often cross-functional, from start to finish with minimal direction.
  
  

Requirements

• Bachelor's in Chemistry, Biology, Microbiology or related field is preferred
• 1 years experience in DEA Compliance, Regulatory Affairs, Pharmaceutical Manufacturing, Quality, and or Product Development is preferred
• Demonstrated success in regulatory strategy development and implementation
• Excellent project management skills with ability to manage multiple projects simultaneously
• Strong analytical and problem-solving capabilities
• Clear written and verbal communication skills
• Experience working effectively in cross-functional team environments
• Proficiency with regulatory submissions software and Microsoft Office suite
• Strong data analysis and reporting skills
• Strong attention to detail and organizational skills
• Ability to interpret and apply complex regulatory requirements
• Customer-focused mindset with business acumen
• Effective interpersonal skills and ability to build consensus