Regulatory Affairs Associate, Animal Health
| Reference Number: 45 |
| Location |
Belleville, ON |
| Reports To: |
Vice President Operations, Quality & Regulatory Affairs |
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| Description |
Overall Job Summary:
The Regulatory Affairs Associate is responsible for preparation of regulatory submissions for the Animal Health division including liaison with government personnel as needed and appropriate.
Specific Accountabilities:
- Preparation of various animal health regulatory submissions specific to drug products but which may include biologics or feed products from time to time
- Liaison with sales and marketing, R&D, quality and manufacturing to obtain information required to assess, prepare and respond to submissions
- Responsible for the coordination and preparation of document packages for regulatory submissions for Animal Health including marketing authorization applications, license renewals and annual registrations.
- Review and recommend changes for labeling, manufacturing information, marketing materials and clinical protocols for regulatory compliance
- Responsible to keep abreast of regulatory procedures and changes
- Interaction with regulatory agencies on defined matters
Education, Work Experience & Competencies
- post secondary education is expected
- minimum 2 years experience in a Regulatory role
- preference given to candidates with experience in regulations relating to veterinary drugs
- Above average computer skills with all Microsoft suite applications required.
- Strong organizational and writing skills
- Ability to liaise with all levels of the organization
Working Conditions:
Conclusions:
The Job Description outlines the Key Accountabilities of the position and should not be considered a detailed description of all requirements that may be inherent in the job. |
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