Senior Regulatory Operations Specialist

Unclassified - Saint Joseph, MO

Full-time - Senior

Saint Joseph, MO

About the position

The Senior Regulatory Operations Specialist plays a crucial role in ensuring that regulatory documentation is maintained, archived, and retrieved efficiently within computerized systems. This position requires a high level of independence and expertise in preparing high-quality regulatory submissions that comply with the requirements set forth by local and federal agencies for the client's products. The specialist will be responsible for ensuring that all submissions are meticulously prepared according to established requirements and submitted within the designated timelines. In addition to submission preparation, the Senior Regulatory Operations Specialist must maintain a comprehensive working knowledge of relevant regulations, policies, and guidelines from appropriate agencies. This includes contributing to the development and implementation of applicable work processes and instructions that enhance the efficiency and effectiveness of regulatory operations. The specialist will also be expected to stay abreast of regulatory trends, understanding and implementing new regulations and guidance as they arise. The role involves interfacing with various stakeholder groups to ensure compliance and providing training for team members in assigned areas of responsibility. The specialist will provide guidance and direction within the regulatory department and among stakeholder groups regarding the regulatory compliance of the client's products and processes. With minimal guidance and supervision, the Senior Regulatory Operations Specialist will support systems for product compliance and maintenance, fulfilling key user responsibilities as applicable.

Responsibilities

• Independently 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 client's products.
• Ensure that 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.
• Maintain advanced and current knowledge of relevant regulations, policies, and guidelines and act as Regulatory Affairs Subject Matter Expert in assigned areas.
• Understand and monitor regulatory trends; understand and implement regulations and guidance.
• Interface with relevant stakeholder groups as needed to ensure compliance.
• Provide training for team members in assigned areas of responsibility.
• Provide guidance/direction within the regulatory department and stakeholder groups relative to regulatory compliance of client's products and processes.
• Support systems for product compliance and maintenance and support key user responsibilities as applicable.

Requirements

• Proven experience in regulatory operations or a related field.
• Strong understanding of US regulatory submission processes and requirements.
• Ability to work independently and manage multiple projects simultaneously.
• Excellent communication and interpersonal skills to interface with stakeholders.
• Detail-oriented with strong organizational skills.

Nice-to-haves

• Experience with computerized regulatory documentation systems.
• Knowledge of international regulatory requirements and submissions.
• Previous experience in training or mentoring team members.