Regulatory Affairs (Operations Specialist)

$70,720 - $75,130/Yr

Cynet Systems - Athens, GA

Full-time - Mid Level

Athens, GA

Professional, Scientific, and Technical Services

About the position

The Regulatory Affairs Operations Specialist will play a crucial role in supporting the maintenance, archival, and retrieval of regulatory documentation within computerized systems. This position requires independent work to assist in preparing high-quality regulatory submissions that are necessary for compliance with local and federal agencies regarding various products. The specialist will ensure that all submissions are meticulously prepared according to established requirements and submitted within the designated timelines. A strong understanding of regulations, policies, and guidelines from relevant agencies is essential, as the specialist will contribute to the development and implementation of applicable work processes and instructions, ensuring they are current and effectively executed. In this role, the specialist will maintain an advanced and up-to-date knowledge of relevant regulations and act as a Subject Matter Expert (SME) in assigned areas of Regulatory Affairs. This includes monitoring regulatory trends and implementing necessary regulations and guidance. The specialist will interface with various stakeholder groups to ensure compliance and provide training to team members in their areas of responsibility. Additionally, the specialist will offer guidance and direction within the regulatory department and among stakeholder groups concerning the compliance of products and processes. With minimal supervision, the specialist will support systems for product compliance and maintenance, fulfilling key user responsibilities as applicable. The ideal candidate will possess a strong background in Regulatory Affairs or equivalent industry experience, demonstrating an intrapreneurial spirit while adhering rigorously to compliance requirements. The ability to collaborate effectively within a global organization and manage a full workload is essential. Strong communication, negotiation, and interpersonal skills are necessary to form productive working relationships across various disciplines and nationalities. Attention to detail, good judgment, and problem-solving abilities are critical, as is the capacity to meet stringent time and quality demands. The specialist should be self-motivated, exhibit a high degree of initiative, and possess well-developed organizational capabilities, all while being a strong team player committed to driving change within the organization.

Responsibilities

• Support data maintenance and archival and retrieval of regulatory documentation in computerized systems.
• Assist with preparing high-quality US regulatory submissions required by local and federal agencies for products.
• Ensure all submissions are prepared per established requirements and submitted within established timelines.
• Maintain working knowledge of regulations, policies, and guidelines with appropriate agencies.
• Contribute to the development and implementation of applicable work processes and instructions.
• Act as Regulatory Affairs Subject Matter Expert in assigned areas.
• Understand and monitor regulatory trends; implement regulations and guidance as necessary.
• Interface with relevant stakeholder groups to ensure compliance.
• Provide training for team members in assigned areas of responsibility.
• Provide guidance and direction within the regulatory department and stakeholder groups regarding regulatory compliance of products and processes.
• Support systems for product compliance and maintenance with minimal guidance and supervision.

Requirements

• Bachelor's degree, preferably in science, and 3 years of relevant industry experience.
• Associate's degree and 5 years of relevant industry experience.
• In lieu of a degree, 8 years of relevant industry experience including 3 years related regulatory experience.
• Knowledge in relevant Regulatory Affairs areas.
• Ability to understand and anticipate regulatory trends.
• Established understanding of regulatory legislation and requirements for the maintenance of veterinary products.
• Strong proficiency in supporting data maintenance and archival and retrieval of regulatory documentation in computerized systems.
• Experience creating detailed work instructions that align with Regulatory Authority and Corporate Regulations for streamlined processes.
• Demonstrated ability to successfully collaborate in a global organization and manage a full workload.
• Effective communicator with good negotiation and interpersonal skills.
• Strong attention to detail and good judgment.

Nice-to-haves

• Experience in Regulatory Affairs submission.
• Familiarity with veterinary product regulations.