Regulatory Manager

Location

Brookings, SD | United States

Job description

COMPANY DESCRIPTION

Medgene Labs helps veterinarians and producers protect livestock with precisely constructed immunological products and services. Applying a strategy of continual diagnostic surveillance and data analytics to the practice of immunology, creating vaccines for the disease at hand quicker and more precisely than previously possible. Medgene Labs has a single mission: To be a world-class Immunological Services Provider™ for leading livestock producers and their veterinarians.

POSITION SUMMARY

Medgene Labs seeks a Regulatory Manager, who is responsible for assisting to ensure all USDA/CVB government regulations are met. The successful candidate will support Medgene's compliance with internal and external regulations, prioritization, and providing regulatory oversight for the research and development department and manufacturing facility. This position will report to the Quality Assurance and Regulatory Director. Professional and experienced in handling a wide range of Regulatory responsibilities. Able to work independently and in a team environment to meet company objectives.

JOB DUTIES

The Regulatory Manager, leading the Regulatory Team, is responsible for ensuring compliance with governing bodies through processes and procedures.

• Operations
  • Regulatory
    • Oversee all U.S. regulatory support and submissions, including pre-licensure and post-licensure activities
    • Liaise with regulatory authorities via written/verbal communication and lead meetings
    • Management and oversight of creation, of product submission to U.S. agencies
    • Participate in communication with regulatory agencies, including face to face and remote meetings, participating in regulatory inspections, and representing the company as required
    • Interact with regulatory authorities during the development and review process to ensure submission approval
    • Support review and approval of Labeling (product, advertising and promotional)
    • Maintain regulatory files as required by procedures
  • Organization
    • Lead team of Regulatory professionals
    • Ensure proper release and distribution of products
    • Monitor Regulatory System and identify Gaps
    • Manage timelines, due dates, and reporting
  • Training and Support
    • Conduct a review of the adequacy and effectiveness of the Management System
    • Support and encourage a Quality Culture and help ensure a safe working environment.
    • Analyze, monitor, and train internal processes.

MINIMUM QUALIFICATIONS:

Knowledge of:

• Advanced Knowledge of USDA Regulatory practices and procedures.
• Excellent time management skills and ability to prioritize work.
• Attention to detail and problem-solving skills.
• Strong written and verbal communication skills.
• Strong organizational and planning skills.
• Proficient in MS Office
• Computer skills and knowledge of office software packages

Ability to:

• Communicate information clearly and concisely.
• Establish and maintain effective relationships with coworkers.
• Think strategically and critically.
• Work within fast-complex, fast-paced work environment.
• Excellent interpersonal skills, flexibility, and adaptability.

Job tags

Salary