Careers

Regulatory Affairs Director

Posting Details

Company: Huvepharma Canada
Location: Remote

Posting Date: October 1, 2019
Closing Date: October 31, 2019

Job Description

Job Function: Regulatory Affairs

Reports to: General Manager - Canada

This position is expected to represent Huvepharma Canada in dealings with the VDD/CFIA and may be expected to present (oral or poster) research or marketing studies at industry technical meetings.May also be required to serve as one of the company’s liaisons to academia and be party of product development and business development dealings.

POSITION RESPONSIBILITIES:

  • Develop regulatory strategies, budgets and timelines for approval process of NDS/SNDS/SANDS
  • Prepare product development plans of regulatory strategies and present to VDD/CFIA
  • Request meetings, conference calls and other correspondence with VDD/CFIA as needed to support regulatory projects
  • Manage contract research organizations to develop study protocols, conduct studies, and prepare reports that are acceptable for submission to VDD/CFIA
  • Communicate with QC, QA and Site Management at the Huvepharma manufacturing facilities concerning CMC activities associated with development of new product registrations, or support of current product registrations
  • Assist with preparation of labels for approved and new products
  • Assist with preparation of marketing materials for all approved products
  • Assist with post approval registration maintenance activities
  • Participate in the overall development and implementation of regulatory strategies
  • Manage regulatory consulting groups

     

 

Qualifications

EDUCATION AND EXPERIENCE:

  • PhD or DVM in an animal science, veterinary medicine, or related field of study
  • Regulatory experience with animal feed additives and veterinary products
  • At least 5 years’ experience working in the regulated animal health environment
  • Experience in maintaining and supervising the post-approval procedures and policies
  • Regulatory experience of the approval process for drug products
  • Regulatory experience in labeling, submission preparation, animal studies protocol preparation and report writing
  • Knowledge of CMC procedures for development of feed additives and veterinary products
  • Experience with analytical method transfers, alternate manufacturing site transfer, alternate API transfer
  • Experience conducting GCP and GLP studies and drug mixing studies
  • Experience dealing with VDD/CFIA

TECHNICAL SKILLS REQUIREMENTS:

Demonstrated ability to handle multiple project, work effectively with all groups of Huvepharma, meet established timelines. Possess excellent verbal and written skills. Bilingualism (English/French) is an asset.

PHYSICAL REQUIREMENTS:

Ability to safely and successfully perform the essential job functions including meeting qualitative and/or quantitative productivity standards.

Must be able to drive an automobile.

COMPETENCIES:

  • Huvepharma Canada:

  • Accountability
  • Integrity
  • Customer Focus
  • Position-Based:

  • Communication
  • Strategic Thinking
  • Coaching & Developing
  • Planning Focus & Stewardship
  • Collaborative Leadership
  • Change Leadership

Contact

Chris Wilson
chris.wilson@huvepharma.ca