Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Position Overview
Under general supervision, performs environmental regulatory strategy and policy development job functions as assigned by management. Typical job responsibilities assist and support management in regulatory compliance specifically during regulatory document development and implementation. The specific work assignment may include duties or activities that assist and support management in one or more of the following functional areas, in addition to other duties as assigned:
Perform environmental regulatory compliance evaluations and strategy/policy development forcomplex regulatory issues for Four Rivers Nuclear Partnership (FRNP) especially related toComprehensive Environmental Response, Compensation, and Liability Act (CERCLA) removal andremedial actions and Resource Conservation and Recovery Act (RCRA) corrective actions at thePaducah Gaseous Diffusion Plant
Provide input and review all CERCLA removal and remedial action documents to incorporatestrategies and ensure regulatory requirements are met
Develop Applicable or Relevant and Appropriate Requirements (ARARs) for CERCLA documents
Serves as the CERCLA Subject Matter Expert for FRNP
Develop regulatory strategies to align FRNP objectives with the Site Management Plan (SMP), whichoutlines DOE's strategic approach for achieving cleanup under the Federal Facility Agreement
Interfaces with groups inside and outside the organization including senior management, DOE, andregulatory agencies
Develop or review/update various plans, policies or procedures, as needed
Complies with security and emergency action procedures
Provides assigned technical or functional support to team members
Other job related duties as assigned
Maintains knowledge of and demonstrates ability to perform work safely in accordance with allapproved safety policies, procedures and applicable regulations and performs assigned duties in asafe manner. If supervising others, has responsibility for the safety of those being supervised andensures they comply with established safety policies and procedures and practice safe work habits
Actively participates in Safety Work Groups
Minimum Requirements
BS degree in a related field and 9 years of related experience, or an equivalent combination of education and experience is required. Typical experience ranges from 9 - 12 years. Must possess a working knowledge of federal, state and local environmental regulations and DOE Orders and requirements. Experience at the DOE Paducah Gaseous Diffusion Plant is preferred but not required.Strong interpersonal and communication skills are required.Must possess a DOE "L" clearance or the ability to obtain a DOE "L" Clearance. Working Conditions Works in an office environment at a normal environmental remediation work-site with some field work while performing regulatory reviews of field work activities. Potential exposure to equipment movement hazards, dangerous chemicals/solvents or hazardous and radioactive materials if proper safety procedures are not followed. Ability to perform sedentary to light work, exerting up to 50 pounds of force occasionally (any exertion of force/lifting greater than 45 pounds requires usage of a two person "buddy system"), non-repetitive, up to 20 pounds of force frequently, and/or up to 10 pounds of force constantly, repetitive; performing such activities as lifting, lowering, carrying, pushing, pulling, standing, walking, grasping, kneeling, stooping, reaching.
Ability to perform primary office duties including heavy computer usage.
In some cases radiological training may be required.
The statements above are intended to describe the general nature and level of work being performed by the person assigned to this position. Principal duties and responsibilities are intended to describe the overall purpose of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform job-related duties as requested by management. All requirements are subject to modification to reasonably accommodate individuals with a disability.
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