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.
