Regulatory Affairs Associate

6 days ago

Winnipeg, Canada IVC Vita Health Full time

**Responsibilities**:

- Provides Regulatory support to IVC-Vita Health’s Natural Health Product business. Interprets relevant regulations and guidance and provides regulatory advice on NHPs to management and other departments
- Secures new NPNs and ensures the maintenance and compliance of all existing market authorizations
- Maintains Vita Health’s Site License, ensuring compliance with applicable regulations
- Leads the creation and maintenance of master labelling texts for NHPs according to applicable regulatory requirements
- Assesses compliance and accuracy of NHP labelling artworks and advertising materials. Provides regulatory artwork approvals
- Provides regulatory support to the qualification of new IVC-Vita raw materials, bulks and finished goods via the MCR process
- Maintains awareness of Canadian regulatory environment. Ensures the implementation of relevant new NHP legislation and requirements within IVC-Vita Health.
- Provides support to the OTC SME on an as needed basis.

**Experience**:

- Minimum of 1-3 years relevant Regulatory experience, including interactions with Regulatory agencies such as Health Canada.
- Vita Health Products Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, national or ethnic origin, colour, religion, age, sex, sexual orientation, marital status, family status, disability and conviction for an offence for which a pardon has been granted or in respect of which a record suspension has been ordered._

Education, Certification, Licenses & Registrations:

- Bachelor of Science or related degree

**Skills**:
**_Expected high performance behaviors: _**
- Fluent in written and spoken English. Knowledge of French language would be an asset
- Superior attention to details
- Superior verbal, written and interpersonal communication skills
- Strong organizational, analytical, problem solving and decision-making skills
- Strong collaboration skills and experience working in teams
- Strong knowledge of relevant technical regulatory requirements, such as the Canadian Food & Drug Act/Regulations
- Experienced in the creation and maintenance of electronic documents using Microsoft Office. Ability to become skilled in the use of other systems and databases

Physical Demands:

- Manual dexterity
- Prolonged sitting, walking short distances
- Extended hours in front of a computer screen and working on a computer keyboard
- Extended hours reviewing artwork, often with small print size
- Visual acuity (proofreading)
- Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Additionally, this job description reflects management’s assignment of essential functions, it does not prescribe or restrict the tasks that may be assigned._

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