Our client is seeking a highly skilled and motivated Senior Specialist in US Regulatory Affairs Operations. This position, based in either St. Joseph, MO or Athens, GA, offers a unique opportunity to be a vital part of a dynamic team, focusing on regulatory compliance and product maintenance for veterinary products.
Key Responsibilities:
- Independently manage data maintenance, archival, and retrieval of regulatory documentation in computerized systems.
- Assist in preparing high-quality US regulatory submissions, ensuring compliance with established regulations and timelines.
- Maintain up-to-date knowledge of relevant regulatory legislation and trends, acting as a Subject Matter Expert.
- Develop and implement work processes and instructions, providing training and guidance to team members.
- Collaborate effectively within a global organization, balancing a full workload with stringent time and quality demands.
Qualifications:
- Bachelor’s degree in science and 3+ years of relevant industry experience, OR an Associate's degree and 5+ years of relevant experience, OR 8+ years of industry experience including 3 years in a regulatory role.
- Strong experience in regulatory documentation management and creating detailed work instructions.
- Excellent communication, negotiation, and interpersonal skills, with a strong ability to form productive working relationships.
- Self-motivated, detail-oriented, and capable of problem-solving with minimal supervision.
- Demonstrated ability to meet tight deadlines while maintaining high standards of work.
Work Environment:
- Monday to Friday, 8 am to 5 pm, 40 hours per week.
- Hybrid work schedule with 2-3 days per week in the office.
This is a fantastic opportunity for a seasoned regulatory affairs professional to make a significant impact in a fast-paced environment. If you are driven, detail-oriented, and passionate about regulatory compliance, we encourage you to apply.
