Regulatory Affairs Specialist III

at  Thermo Fisher Scientific

Regulatory Affairs Specialist III
Thermo Fisher Scientific Inc. is seeking a highly motivated and experienced Regulatory Affairs Specialist III to join our world-class team in Memphis. This role will be a key contributor to the BioServices & Speciality Logistics (BSL) quality team, to support the DEA compliance profile for BSL North America and consult on regulatory framework and compliance initiatives. Under the direction of the Senior Manager, Quality, the Regulatory Specialist III is primarily responsible for development of processes relating to FDA, DEA, TSA, and individual state regulatory compliance, state licensure management and oversight of the regulatory affairs function within the business unit. They will ensure that these multifaceted service lines are implemented, managed, and maintained in a compliant fashion. As a global leader in serving science, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. Join us and play a crucial role in driving innovation and supporting patients in need.

Responsibilities:

• Management of FDA, DEA and TSA regulatory requirements including hosting inspections as needed.
• Implement and maintain site SOPs that adhere to applicable regulatory requirements and Thermo Fisher policies as well as, developing/improving appropriate local processes, where needed. This will include working with relevant team members to align on requirements.
• Act as the Controlled Substances Coordinator for assigned BSL facilities.
• Responsible for the oversight of documentation and execution of all controlled substance transactions (e.g. cage checkout/in, inventory reconciliation, record keeping, etc).
• Complete and maintain DEA 106 Forms and other official documentation such as inspection readiness packs
• Apply for and maintain current licensure and registrations for FDA, DEA, State Licensure, VAWD and TSA, as applicable
• Prepare and submit regularly required DEA, State, FDA and TSA reporting (e.g. ARCOS reporting).
• Assist in the development and growth of a DEA security culture at the site for colleagues and contractors to ensure DEA compliance, including developing and delivering training to employees.
• Support the internal audit process by coordinating the relevant audits of the controlled substances processes, as required.
• Generate and report metrics to the leadership team regarding licensure compliance
• Provide assistance and support to the overall quality management system as it pertains to regulatory inputs.
• Manage state licensure for assigned facilities including, but not limited to, ensuring all state requirements are met, maintaining active licensure and handling the license expiry/renewal process.
• Maintain the relationship with any and all vendors employed to assist with regulatory processes (e.g. licensure management).
• Facilitate regulatory reviews and work with global quality as the business expands into new service lines.
• Ensure operation under GxP principles and standards as well as compliance with global Thermo Fisher policies and procedures.
• Ownership of change management including specific quality action items associated with regulatory compliance.

Requirements:

• Bachelor’s degree in a scientific or related field preferred. Equivalent combinations of education and experience will be considered.
• Minimum of 3 years of experience in Regulatory Affairs within the pharmaceutical or biotech industries
• Experience interpreting and working under the regulations governing the expectations and processes employed by the FDA, DEA and EU regulatory agencies.
• Additional experience with similar ex-US regulators (e.g. Japan PMDA, Australian TGA, Health Canada etc.) is desirable.
• Solid understanding of GMP/GDP principles pertaining to a pharmaceutical distribution environment
• Experience in participating in and/or hosting inspections
• Proven track record of successfully implementing regulatory strategies
• Flawless attention to detail and strong analytical skills

KNOWLEDGE, SKILLS, ABILITIES:

• Proficient in FDA, DEA, TSA and state licensing regulations and requirements.
• Project planning and working knowledge of Excel, Word, Access, and quality management software
• Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment
• Leadership skills: Proven skills in influencing others, leading significant change and discuss outcomes
• Work demeanor that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making
• Strong communication skills both written and verbal

• Management of FDA, DEA and TSA regulatory requirements including hosting inspections as needed.
• Implement and maintain site SOPs that adhere to applicable regulatory requirements and Thermo Fisher policies as well as, developing/improving appropriate local processes, where needed. This will include working with relevant team members to align on requirements.
• Act as the Controlled Substances Coordinator for assigned BSL facilities.
• Responsible for the oversight of documentation and execution of all controlled substance transactions (e.g. cage checkout/in, inventory reconciliation, record keeping, etc).
• Complete and maintain DEA 106 Forms and other official documentation such as inspection readiness packs
• Apply for and maintain current licensure and registrations for FDA, DEA, State Licensure, VAWD and TSA, as applicable
• Prepare and submit regularly required DEA, State, FDA and TSA reporting (e.g. ARCOS reporting).
• Assist in the development and growth of a DEA security culture at the site for colleagues and contractors to ensure DEA compliance, including developing and delivering training to employees.
• Support the internal audit process by coordinating the relevant audits of the controlled substances processes, as required.
• Generate and report metrics to the leadership team regarding licensure compliance
• Provide assistance and support to the overall quality management system as it pertains to regulatory inputs.
• Manage state licensure for assigned facilities including, but not limited to, ensuring all state requirements are met, maintaining active licensure and handling the license expiry/renewal process.
• Maintain the relationship with any and all vendors employed to assist with regulatory processes (e.g. licensure management).
• Facilitate regulatory reviews and work with global quality as the business expands into new service lines.
• Ensure operation under GxP principles and standards as well as compliance with global Thermo Fisher policies and procedures.
• Ownership of change management including specific quality action items associated with regulatory compliance