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Regulatory Affairs Manager in Fort Worth, TX at Vetoquinol USA

Date Posted: 4/19/2019

Job Snapshot

Job Description

The Regulatory Affairs Manager leads the regulatory development, strategies, and life cycles of R&D pre-approval projects.   The Regulatory Affairs Manager reports directly to the Regulatory Affairs Manager of North America and Europe and works closely with R&D Project Teams and the Global Regulatory Platform in the building and execution of regulatory submissions, serving as the primary contact/agent with US regulatory agencies in accordance with US and Group policies for the subsidiary.   

Essential Functions

Dossier Submissions

  • Develops, facilitates and executes comprehensive regulatory strategies to accelerate and ensure successful product registrations in the USA for new product launches and change management to commercialize veterinary product registrations.
  • Manages submissions and regulatory affairs support to facilitate the registration of new pharmaceutical products including small molecules, biopharmaceuticals and bioactive large molecules, but may also include generics, pesticides, and health / nutritional products.

Subject Matter Expert

  • Maintains current knowledge of relevant regulations, ensuring that Vetoquinol product development complies with the regulations of the US and/or global regulatory agencies with a focus on Regulatory Affairs
  • Keeps 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 in light of 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 maintain 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

 

Job Requirements

Education

  • DVM, MS or Ph.D. degree in Regulatory Affairs, Chemistry, Biology, Engineering, Pharmaceutical or Animal Sciences, or related field

Experience

  • A minimum of 5 years experience in direct interactions with the FDA-CVM is required.
  • Experience in GLP, GCP and cGMP regulated industry is required
  • Intimate knowledge of regulations, as well as guidance documents and the ability to conduct submissions / e-submissions is expected
  • Direct experience in animal health pharmaceutical product development is required. EMA experience is 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