Regulatory Compliance Specialist III - United States
The Regulatory Compliance Specialist III effectively performs activities as directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. Assists with the development of SOPs or other quality documents as needed. At this level an employees may serve as the Lead Inspector for external audits and may consult with clients on routine regulatory issues.
Those who support the Regulatory group will also be required to file various regulatory submissions and may be required to interact with US and international regulatory authorities.
Key Job Responsibilities:
Performs quality review and approval of documents, data, protocols, and/or reports.
Performs internal and external quality audits and/or inspections.
May serve as a Lead Inspector for external audits.
May consult with clients on routine regulatory issues.
Hosts client audits and inspections.
Maintains quality databases.
Assists with the implementation and supports quality systems, including but not limited to vendor management, training, internal audit program, and overall regulatory inspectional readiness initiatives.
Assists with quality improvement initiatives as needed.
Assists with development of SOPs or other quality documents as needed.
Effectively performs duties, on schedule, with accuracy and competency.
Maintains accurate files and records.
Serves as an effective member of the Regulatory Compliance team and may serve as a mentor to other Regulatory Compliance employees in area of expertise.
Performs other duties as assigned.
Complies with company polices and SOPs.
Works the hours necessary to meet scheduling commitments, is punctual with minimal absenteeism.
Travel: Some domestic and international travel may be required.
Additional Key Responsibilities Specific to the Regulatory Group:
Submit minor and routine regulatory submissions and will be trained (or be able to be trained) in submitting major regulatory submissions.
Essential Job Requirements:
Bachelors degree in Chemistry, Biology, or related field with 6+ years GMP related experience or Masters degree in related field with 2+ years related experience, or equivalent educational and work experience.
Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
Good written and oral communication skills.
Good math skills.
Good computer skills and knowledge of Microsoft Office products.
Ability to be trained and to mentor.
Ability to act independently.
Ability to interact well with clients and regulatory agents.
Ability to interact well with employees at all levels.
Ability to act as a consultant.
Certifications - None required.
Supervision Received: Limited
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. May determine the methods and procedures on new assignments, but still accomplishes goals within defined procedures and practices. Seeks management direction for problems of diverse and/or complex scope.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms.
The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance.
The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.
Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, or manufacturing areas for inspections or work discussions. The noise level in these additional work areas may be louder. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.
LIMITATIONS AND DISCLAIMER
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.