Regulatory Affairs Associate

3 weeks ago

Windsor, Canada Jamieson Wellness Inc. Full time

Overall Responsibilities
Reporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as international customers, requiring a dynamic individual able to properly interpret and communicate regulatory requirements to meet with needs of the business.

Specific Key Responsibilities & Duties
Assembly and tracking of registration dossiers in a timely and accurate manner
Requesting and preparing raw material (RM) and finished good (FG) samples to be shipped for product registrations in a timely and accurate manner
Assembly and tracking of export documentation and license renewals in a timely and accurate manner
Working with QC/QA/R&D in the development of new raw material (RM) and finished good (FG) specs to bring in to compliance with regulations
Working with account managers to help answer customer questions, concerns and/or provide further documentation if needed
Reviewing ingredients/formulas for alternate markets based on regulatory requirements
Reviewing technical documentation generated, from both internal and external sources, for international registrations r Reviewing international labels for compliance
Follows 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
ldentifying creative solutions for overcoming regulatory challenges
Identifying new opportunities for lnternational sales within the regulatory environment
Manage and track long-term goals the contribute to the broader objectives of the Regulatory Affairs department and the organization.
Other duties and projects as deemed necessary

Knowledge, Skills & Abilities Requirements
Bachelor degree in Science/Biological Sciences
Regulatory experience an asset
Ability to understand and interpret technical documents
Ability to use scientific judgement with minimal supervision
Ability to multitask and complete work in a timely manner
Excellent written and oral 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
Must be able to come into the Windsor, Ontario office several times a week

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