Regulatory Affairs Specialist - Europe

Institut Rosell-Lallemand Inc.; Canada; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading agricultural biotechnology firm in Canada seeks a Regulatory Affairs Specialist to oversee product registration and ensure compliance with regulatory requirements. This role involves collaboration with internal teams and regulatory authorities, and the ideal candidate will have a background in life sciences, excellent communication skills, and experience in regulatory affairs. Competitive salary and opportunities for professional development are offered.

Qualifications

• Experience in regulatory affairs or compliance in a scientific environment.
• Strong communication skills and ability to work across departments.
• Knowledge of international regulatory requirements for product registration.

Responsibilities

• Oversee product registration processes and ensure compliance with regulations.
• Communicate with regulatory agencies and internal stakeholders.
• Support development of product labeling and packaging compliance.

Skills

Regulatory compliance

Communication

Project management

Collaboration

Education

Degree in life sciences or related field

Tools

SharePoint

Job description

Grow into Regulatory Affairs Specialist at Lallemand Plant Care in Europe: Join our team and an exciting business!

The Regulatory Affairs Specialist plays a key role in all aspects of registration activities for LPC products in Europe, and acts as a link between the company and regulatory authorities, ensuring that products are developed, manufactured, commercialized, marketed and distributed in compliance with all appropriate legislations.

Overview

The Regulatory Affairs Specialist interacts with all internal LPC departments and external collaborators (including suppliers, regulators, third-party consultants, research laboratories and external stakeholders).

Product registration and compliance management

• Collaborate on the entire product registration process, including the preparation of new product dossiers, amendments, renewals, research authorizations, developing registration strategies, and ensuring compliance with local and regional regulations.
• Oversee registration renewal and maintenance activities.
• Monitor the regulatory environment, adapt to new data requirements, and communicate updates to relevant functions.
• Contribute to the development of product dossiers, including efficacy, safety (tox, ecotox), and other data from internal or third-party entities.
• Support Supply Chain & Logistics and Product Management on product labeling and packaging compliance.
• Support the development of labels, leaflets, and packaging in accordance with the information provided by regulatory agencies and validate the technical and regulatory information, monitoring the entire process of creation and production with the sectors and suppliers involved ensuring that they meet the standards established.
• Support the S&OP and Product Management on labeling and packaging of products in compliance with relevant regulations and approvals.
• Work with S&OP to manage actions related to import/export requirements of products and microorganisms.
• Assist in the development of a regulatory archive and documentation in SharePoint.

Internal and external communication and support

• Communicate with internal departments (R&D, Quality Assurance, Technical Marketing, etc.) to obtain information for regulatory dossiers and reply to regulatory inquiries.
• Contribute to contracts management with research institutions and third parties that involve product development, sharing of intellectual property, and technology transfer.
• Represent the company at conventions, seminars, conferences, congresses, and actively participate in committees, task forces and business development trainings with regulators and relevant trade associations specific to Europe.
• Collaborate in lobbying and advocacy with regulators to improve registration processes for biologicals.
• Support local marketing with label development, creation of promotional marketing materials and representation at trade shows.
• Provide direct support and guidance to Field Solutions on the planning, conduct and report generation for field trails intended for regulatory purposes.

The Regulatory Affairs Specialist