Regulatory Affairs Associate - Windsor, Canada - Jamieson Wellness Inc.

Description

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