GMP Regulatory Affairs Specialist

Requisition Id 11400 

Level: TP04

Overview: 

Oak Ridge National Laboratory (ORNL) is seeking an experienced regulatory affairs professional to join the Medical Isotope Active Pharmaceutical Ingredient (API) team. This individual will serve as the coordinator and subject matter expert (SME) for regulatory submissions in a small batch radionuclide manufacturing environment. ORNL is a leading scientific organization operating at the forefront of radionuclide production, developing innovative production and purification processes for radiochemical grade and cGMP grade radionuclides used for research, industry and pharmaceutical products. The ideal candidate will be a diligent and knowledgeable professional willing to adapt best practices to an evolving manufacturing environment. A self-starter with the experience and knowledge of the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other world regulatory body requirements for API manufacturing. They should have experience preparing and filing Drug Master Files (DMFs) and be knowledgeable and experienced in current Good Manufacturing Practice (cGMP) implementation.

Major Duties/Responsibilities: 

• Prepare and file new DMFs with the FDA.
• Provide regulatory oversight and life cycle management of DMFs, annual reports, and related regulatory submissions and updates.
• Generate, review, and approve various Chemistry, Manufacturing, and Controls (CMC) documents required for regulatory filings.
• Verify the review and approval of Change Controls, Technical Deviations, Methods, Specifications, Certificates of Analysis (COAs), Batch Records, Validation protocols/reports for regulatory impact and disposition accordingly.
• Collaborate with team leadership to strategically develop processes to facilitate effective management of a complex regulatory environment.
• Direct interaction with regulatory bodies (e.g., FDA), on ORNL DMF submission, and lead associated audits and assessments.
• Ensure all submissions and projects are accurate and completed within the expected timelines.
• Maintain full awareness of all regulatory activities on assigned projects and ensure that project deadlines and performance standards for these projects are established and met.
• Coordinate with various API manufacturing lines on regulatory compliance and cGMP implementation.
• Actively work with project management teams and other cross-functional departments to review CMC documents for all regulatory submissions of various product lines in a timely manner.
• Maintain the Regulatory documents and communication with regulatory agencies.
• Facilitate administrative and technical review of regulatory submissions (internal /external DMF) for completeness, adequacy and compliance with the current regulations and guidance to ensure timely actions.
• Manage electronic publishing (need based), establishment registrations, self-identifications, and other related compliance activities.
• Provide strategic regulatory support to development teams (R&D, quality, and production) related to the development  of new cGMP compliant radionuclide product lines.
• Review all pre-filing and preapproval submissions from internal teams in accordance with current regulations.
• Communicate significant and/or potential issues affecting the regulatory compliance to management and key stake holders.
• Keep up-to-date and advise the organization on new and existing regulations, regulatory guidance and compliance requirements that affect the products in development and review.

Basic Qualifications:

• Bachelor’s degree biology/chemistry/other technical field and/or relevant experience.
• Direct experience in writing, reviewing, and submission of DMFs and amendments for regulatory submissions.
• 10 years’ experience in a regulatory focused role with 5 years in a regulatory management role.
• Position requires attention to detail and the ability to work as a team player interacting with multiple internal and external sites and with a culturally diverse group.
• Demonstrated ability to identify and address potential regulatory issues in an R&D environment.
• Able to adapt and build processes to accommodate evolving product base in a dynamic environment.
• Thorough understanding of the regulations and guidance published by United States Food and Drug Administration (US FDA) and other world regulatory body requirements as applicable to DMF preparation, filing and maintenance.
• Experience in drafting new DMF submissions and amendments.
• Thorough understanding of the ICH and cGMP requirements regarding API manufacturing.
• Understanding the product development and manufacturing process of API eCTD requirements and life cycle management.

Preferred Qualifications:

• Knowledge of Nuclear Quality Assurance-1 (NQA-1) and experience with radiopharmaceuticals in a regulatory capacity.
• Familiarity with cleanroom environments and operations.
• Well-rounded experience in the writing and management of regulatory submissions.
• Strategic planning in the development of new processes.
• Strong oral and written communication skills.
• Strong organizational skills, attention to detail and adaptability.
• Proven ability to anticipate and negotiate challenges to achieve desired outcomes.
• Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.

Q clearance: This position requires the ability to obtain and maintain a security clearance from the Department of Energy. As such, this position is a Workplace Substance Abuse (WSAP) testing designated position. WSAP positions require passing a pre-placement drug test and participation in an ongoing random drug testing program.

This position will remain open for a minimum of 5 days after which it will close when a qualified candidate is identified and/or hired.

We accept Word (.doc, .docx), Adobe (unsecured .pdf), Rich Text Format (.rtf), and HTML (.htm, .html) up to 5MB in size. Resumes from third party vendors will not be accepted; these resumes will be deleted and the candidates submitted will not be considered for employment.

If you have trouble applying for a position, please email ORNLRecruiting@ornl.gov.

ORNL is an equal opportunity employer. All qualified applicants, including individuals with disabilities and protected veterans, are encouraged to apply.  UT-Battelle is an E-Verify employer.