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Regulatory Affairs Specialist

2 months ago

Athens, United States Compunnel Inc. Full time

Job Tittle: Senior Specialist, US Regulatory Affairs Operations

Duration: 18 Months (Possible Extension)

Location: Athens, GA (Onsite work)


Job Description:

Responsibilities:

  • Independently support data maintenance, archival, and retrieval of regulatory documentation in computerized systems.
  • Assist with preparing high-quality US regulatory submissions required by local and federal agencies for client products. Ensure all submissions are prepared per established requirements and submitted within set timelines.
  • Maintain a working knowledge of regulations, policies, and guidelines with appropriate agencies.
  • Contribute to the development and implementation of applicable work processes and instructions, ensuring they are kept up to date and implemented.
  • Maintain advanced and current knowledge of relevant regulations, policies, and guidelines and act as a Regulatory Affairs Subject Matter Expert (SME) in assigned areas.
  • Understand and monitor regulatory trends; implement relevant regulations and guidance.
  • Interface with relevant stakeholder groups as needed to ensure compliance.
  • Provide training for team members in assigned areas of responsibility.
  • Offer guidance and direction within the regulatory department and to stakeholder groups regarding regulatory compliance of client products and processes.
  • With minimal supervision, support systems for product compliance and maintenance and perform key user responsibilities as applicable.


Knowledge and Experience:

  • Proficient in relevant Regulatory Affairs areas.
  • Ability to understand and anticipate regulatory trends.
  • Strong knowledge and understanding of regulatory legislation and requirements for the maintenance of veterinary products.
  • Proven ability in supporting data maintenance, archival, and retrieval of regulatory documentation in computerized systems.
  • Strong experience in creating detailed work instructions aligned with Regulatory Authority and client Corporate Regulations for streamlined processes.


Experience:

  • Regulatory Affairs or equivalent industry experience required.


Competencies:

  • Intrapreneurial spirit while maintaining rigorous and disciplined compliance.
  • Ability to successfully collaborate in a global organization and manage a full workload.
  • Effective communicator with strong negotiation and interpersonal skills, capable of forming productive working relationships across disciplines and nationalities.
  • Strong attention to detail.
  • Exhibits good judgment and problem-solving capabilities in daily work.
  • Ability to meet stringent time and quality demands.
  • Self-motivated with a high degree of initiative, commitment, and persistence.
  • Well-developed organizational skills.
  • Collaborative team player with a commitment to the mission of client, while also capable of driving change.
  • AAI Competencies


Education:

Bachelor's degree, preferably in science, and 3 years relevant industry experience OR Associate's degree and 5 years of relevant industry experience OR In lieu of degree, 8 years of relevant industry experience including 3 years related regulatory experience.