Job Description

Job Description

Job Title: Regulatory affairs Coordinator Posting Date: February 7, 2022
Department: Regulatory Affairs Closing Date: February 14, 2022
Reports to: Ani Byrne Location: Windsor (Rhodes)
Posting Number:211-21

Company Overview
At Jamieson Wellness, we’re dedicated to improving the world’s health and wellness with our portfolio of innovative natural health brands. Established in 1922, Jamieson Vitamins is our heritage brand, available in over 45 countries and recognized as Canada’s #1 consumer health brand. We manufacture and market sports nutrition products and specialty supplements under our Progressive, Precision and Iron Vegan brands, and market products by Smart Solutions, the #1 women’s natural health focused brand in Canada. In 2017, Jamieson Wellness was named one of the top ten most reputable companies in Canada. For more information, please visit jamiesonwellness.com.

Overall Responsibilities
The Regulatory Affairs Co-Ordinator will organize the activities of the (domestic) Regulatory department, including preparing and maintaining regulatory submissions to Health Canada, primarily the NNHPD (Natural and Non-Prescription Health Products Directorate). The position requires frequent interaction with the QC/QA/R&D/Research/External Quality/Marketing/Graphics Departments, as well as other company divisions to collaboratively interface updated regulations with current practices. This position requires a dynamic individual able to seamlessly liaise regulatory requirements with internal and external direction.

Specific Key Responsibilities & Duties
• Co-ordinate the assembly and tracking of (primarily) natural health product (NHP) applications to Health Canada in a timely and accurate manner (and potentially cosmetic and drug applications) including, but not limited to: licence applications, label submission creation, allergen review
• Working with internal departments such as: QC/QA/R&D/Research/External Quality in the development/review of new raw material (RM) and finished product (FG)
• Review specifications to bring into compliance with regulations
• Perform regulatory review of proposed new products/ingredients
• Monitor and maintain site license applications for all company divisions
• Collect and review, where necessary, scientific documentation from various external sources
• Review labels for compliance of all company divisions
• Service regulatory requirements wherever needed for Nutricorp customers (private label customers)
• Attend/represent Jamieson at offsite/virtual training related to regulations and report this information back to the rest of the team, where necessary (as appropriate)
• Maintaining knowledge of changing regulatory environments primarily in Canada, but also globally and potential Canadian impacts
• Service regulatory requirements wherever needed for Nutricorp
• Train new staff as required
• Health & Safety Policies/SOPs including but not limited to the Safety Responsibilities Procedure
• Will comply with Good Manufacturing Practices in all GMP sensitive areas of Jamieson Laboratories Ltd. facilities
• Other duties and projects as deemed necessary

Knowledge, Skills & Abilities Requirements
• Bachelor degree in Science required
• 3-5 years of regulatory experience in a natural health product or pharmaceutical environment
• Working knowledge of regulations for other global jurisdictions would be considered an asset
• Ability to understand and interpret technical and regulatory documents
• Excellent written communication skills
• Strong organizational and administrative skills
• Proficient with computers; working knowledge of MS Word, MS Excel, etc. and general ERP systems (such as QAD)
• Commitment to continuous professional improvement
• Ability to obtain results with minimal supervision in a team environment
• Team oriented

Our Values
ACCOUNTABILITY
• We take personal ownership and pride in everything we do
• We demonstrate a bias for action
• We challenge the status quo constantly seeking to improve
• We eliminate barriers and bias to empower others to achieve our goals
• We are accountable to build and promote environments free of bias in regard to race, gender, sexual orientation, and all other types of discrimination
TEAMWORK
• We constructively challenge ourselves and others to achieve desired outcomes
• We demonstrate mutual respect, inspire trust and promote equality with colleagues and partners alike
• We collaborate toward common vision and objectives across all persons, levels, functions and locations as one company
• We recognize, celebrate and value each other’s differences, styles and contributions as one of our greatest strength
• We lead with a passion for winning together
ENTREPRENEURSHIP
• We are empowered to pursue opportunities that will have great impact
• Our curiosity drives us to find better ways to accoumplish our goals
• We are agile, embrace change and persevere through adversity
• We demonstrate initiative and take calculated risks together
INTEGRITY
• We do what is right even when it’s not easy
• We demonstrate humility in everything we do
• We courageously stand up and support our diverse heritages, traditions, experiences, beliefs and styles
• We allow ourselves to be vulnerable, admit mistakes, learn from them and move forward
TRANSPARENCY
• We respectfully communicate honestly and directly in a timely manner
• We proactively seek diversity of ideas and provide real feedback in the interest of improvement and development
• We constructively share and respect each other’s opinions and ideas to enable sound decision-making at all levels
• We encourage differing point of views and productive debate to develop the best solutions
EXTERNAL FOCUS
• We focus our efforts with the community, consumer and customer in mind
• We continually seek opportunities through insights that affect our business, customers, consumers, government, environment, technology, competition and suppliers
• We foster positive collaboration with external partners that promote diverse and inclusive environments

How to Apply

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: Not Disclosed.

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