(Archived) Regulatory Affairs Manager

This position ideally will be based in Fort Worth, Texas but remote options, with travel required to meet business needs, can be considered based on candidate.

Description

Reporting directly to the Vetoquinol USA Inc. Business Area Director for Scientific Affairs, the Vetoquinol USA Inc. Regulatory Affairs Manager, will be accountable for post-approval regulatory affairs, associated reporting, and submissions to relevant authorities in support of a dynamic and diverse range of commercialized products. As part of the US Regulatory Affairs team, this position will serve as an animal health regulatory affairs generalist and a source of expertise for supplemental, feed, and non-prescription products for the affiliate including responsibility for select non-drug products in development.

Essential Functions

US Regulatory Affairs

• For any non-prescription products which Vetoquinol USA Inc. is the product owner, the US Regulatory Affairs Manager will be accountable for:
  • The system and processes for review of all marketing or promotional materials and any associated submissions to regulatory or concerned authorities
  • Regulatory review of labels and label changes and associated submissions for commercial products
  • Maintenance of non-pharmaceutical, drug-listed, and EPA registered commercial products
  • Post-approval reporting and submissions as required
  • Internal training programs for employees related to the regulatory and legal landscape
  • Development and execution of comprehensive regulatory strategies to accelerate and ensure successful US launch for new non-prescription products or product offerings
• This position will be accountable for all authority submissions and support for documentation related to Imports and Exports for all non-commercial and commercial products
• This position will functionally report to the Global Director of Regulatory Affairs as part of the Vetoquinol GROUP Regulatory Affairs network and will comply with all GROUP level reporting and training as per Corporate SOPs and Policies
• This position will not be accountable for Pharmacovigilance

Subject Matter Expert

• For the US Regulatory Affairs team for all EPA, nutritional, drug-listed, and non-drug products; will work in collaboration with other US Regulatory Affairs Managers for pharmaceutical drugs
• Will maintain current knowledge of relevant regulations, ensuring that Vetoquinol products comply with those of the US and/or global regulatory agencies
• Will keep abreast of US and international legislation, guidelines, and customer practices

Lobbying

• Develops and fosters working relationships with US regulatory agencies and with industry associations
• Provides technical leadership and recommendations to R&D project teams and functions through interpretation of new and emerging US regulatory trends pertinent to the business needs
• Implements strategies and/or processes to optimize regulatory performance considering those trends

General/Administrative

• Supports the company vision and mission, and demonstrates the corporate core values in all professional activities
• Complies with all OSHA safety requirements, work rules, and regulations
• Compiles and maintains all required paperwork, records, documents, etc.
• Follows systems and procedures outlined in company manuals
• Maintains departmental housekeeping standards

• All other duties as requested by management

Qualifications

Competencies

• Adaptability
• Cultivating Networks and Partnerships
• Planning and Organizing
• Strategic Planning
• Technical/Professional Knowledge and Skills

Education

• MS, JD, or Ph.D. degree in Food Science, Regulatory Affairs, Legal Studies, Chemistry, Biology, Engineering, Pharmaceutical or Animal Sciences, or related field

Experience

• A minimum of 10 years experience in the animal health industry
• Direct interactions with, or experience with, industry associations such as NASC or AAFCO is required
• Experience in cGMP regulated pharmaceutical or food industry is required
• Intimate knowledge of regulations as well as guidance documents and the ability to conduct registrations is expected
• Direct experience in animal health product development is desirable
• EPA and USDA (import/export) experience are highly desirable
• Experience in working on dispersed project teams and/or with contract research organizations (CROs) is highly desirable

Personal Attributes

• Strong technical and scientific writing skills
• Emotional intelligence with a strong risk-based decision-making background
• Exceptional organizational and time management skills
• Highly developed interpersonal skills, possessing an ability to work with a diverse population
• Ability to function independently in a multi-task environment, as well as part of a team
• Ability to work with international internal and external partners from diverse cultural backgrounds in a matrixed environment
• A desire to serve

Please apply via https://www.vetoquinolusa.com/careers