Senior Regulatory Compliance Specialist

2 weeks ago

Memphis, Tennessee, United States Thermo Fisher Scientific Full time
Position Overview:
Thermo Fisher Scientific is on the lookout for a dedicated and experienced Senior Regulatory Compliance Specialist to become an integral part of our esteemed team. This role is pivotal in ensuring adherence to regulatory standards and enhancing our operational excellence.

Key Responsibilities:
  • Oversee compliance with FDA, DEA, and TSA regulations, including the facilitation of inspections as necessary.
  • Develop and uphold site Standard Operating Procedures (SOPs) that align with regulatory requirements and company policies, while also enhancing local processes as required.
  • Serve as the Controlled Substances Coordinator for designated facilities, ensuring meticulous documentation and management of controlled substance transactions.
  • Maintain and prepare essential documentation such as DEA 106 Forms and inspection readiness materials.
  • Manage applications and upkeep of necessary licenses and registrations for FDA, DEA, State Licensure, VAWD, and TSA.
  • Compile and submit mandatory reports to DEA, State, FDA, and TSA.
  • Foster a culture of security and compliance regarding controlled substances through training and awareness initiatives.
  • Support internal audits related to controlled substances processes.
  • Generate compliance metrics for leadership review.
  • Manage state licensure for assigned facilities, ensuring all regulatory requirements are met and licenses are renewed timely.
  • Collaborate with vendors to streamline regulatory processes.
  • Facilitate regulatory assessments as the organization expands its service offerings.
  • Ensure operations adhere to GxP principles and global company policies.
  • Lead change management initiatives related to regulatory compliance.

Qualifications:
Applicants should possess a Bachelor’s degree in a scientific or related discipline, with a minimum of three years of experience in Regulatory Affairs within the pharmaceutical or biotech sectors. Familiarity with FDA, DEA, and EU regulations is essential, and experience with international regulatory bodies is advantageous.

Skills and Competencies:
  • In-depth knowledge of FDA, DEA, TSA, and state licensing regulations.
  • Proficient in project planning and familiar with Microsoft Office applications and quality management software.
  • Exceptional interpersonal skills to foster relationships with stakeholders.
  • Demonstrated leadership capabilities in driving change and achieving results.
  • Strong communication skills, both written and verbal.

Additional Requirements:
Candidates must meet all criteria for handling controlled substances, including successful background checks. A commitment to accuracy and detail is crucial, along with the ability to work independently and solve problems effectively.

At Thermo Fisher Scientific, we celebrate diverse experiences and perspectives, fostering an inclusive and collaborative workplace.

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