Regulatory Affairs Specialist Iii

Job Description
Job Title: Regulatory Affairs Specialist 3
How will you make an impact?
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!
Location/Division
Memphis, TN / BioServices & Speciality Logistics
How will you make an impact?

• Management of FDA, DEA and TSA regulatory requirements for BSL North America facilities including hosting inspections, as needed.
• Implement and maintain SOPs that adhere to applicable regulatory requirements and Thermo Fisher policies for the BSL business unit, as well as, developing/improving appropriate local processes, where needed. This will include working with relevant partners to align on requirements.
• 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 regular DEA, State, FDA and TSA reporting, as required (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. This includes, but is not limited to, developing and delivering training to employees.
• Support the internal audit process by coordinating the relevant audits of the controlled substances processes.
• Generate and report metrics to the leadership team regarding FDA, DEA, TSA and state licensure compliance
• Work within the quality team and provide assistance and support to the overall quality management system as it pertains to regulatory inputs.
• Lead state licensure activities 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 organizational and process changes including specific quality action items associated with regulatory compliance.

How will you get here?
Education
Bachelor's Degree in Science or equivalent experience including DEA
Experience

• Proven experience in Regulatory Affairs within the pharmaceutical or biotech industries
• Proven proficiency 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.
• Proven proficiency in GMP/GDP principles pertaining to a pharmaceutical distribution environment
• Proven experience in participating in and/or hosting inspections
• Meet all requirements for handling of controlled substances including passing relevant background checks
• Digital literacy with an understanding of Microsoft Windows applications
• Ability to maintain a high level of accuracy and attention to detail.
• Ability to work independently and possess problem solving ability

Knowledge, Skills, Abilities:

• Proficient in FDA, EU, DEA, TSA and state licensing regulations and requirements.
• Project planning and proven understanding 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, sophisticated business environment
• Consistent record in partnering to influence others and lead significant change
• Strong interpersonal skills both written and verbal

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
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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