Compliance Coordinator

Company Description

ABOUT LGC STANDARDS
LGC Standards is a division of LGC Group, the UK’s designated National Measurement Institute for chemical and bioanalytical measurements. We are a leading global manufacturer and service provider of quality assurance and research tools, supporting analytical needs in more than 120 countries worldwide. We use our expertise to produce to the highest standards, including ranges produced under ISO/IEC 17025 and accredited to ISO 17034. Our wide range of reference materials and proficiency testing schemes is complemented by our experience in outsourcing and customs, enabling us to adapt quickly to provide tailored solutions that meet our customers’ analytical needs. We innovate and apply science in order to ensure the safety and integrity of products and services, in line with our vision of science for a safer world.

Job Description

Job Purpose

To provide support to business compliance to regulatory requirements via preparation, compilation, maintenance, and submission of various regulatory reports, applications, and forms to Health Canada and other regulatory agencies including acquiring approvals for new products.

Key Responsibilities

• Prepare compliance documentation to meet company and legislative requirements
• Provide administrative support to the Compliance Department:
• Maintain and manage the compliance filing system for regulatory documents.
• Organizing and dispersing inquiries received from external and internal customers.
• Ensure that files, log sheets and records are kept up to date (i.e. export permits, product files, manufacturing changes).
• Prepare and summarize the compliance related monthly/quarterly/annual reports, amendment applications etc. are submitted to the regulatory authorities in timely manner.
• Assess customer order requirements to ensure legislative requirements are met
• Supporting Order to Cash process for controlled/ regulated products at TRC
• Assessing customer order requirements to ensure legislative requirements are met
• Ensure order specific requirements are promptly communicated to appropriate departments
• Coordinate with departments at site including Customer Service, Finished Goods, Shipping teams, Procurement, Production, Analytical, for regulated substance related activities.
• Assists in the management of regulatory programs and activities involving compliance to regulations and maintenance of all transaction records.
• Proactively handle and communicate issues, scopes, progress and risks to ensure Supervisor and other members of the Compliances team are kept informed as appropriate
• Maintain administrative compliance of government regulations and requirements related with Controlled Substances and ECL, OZD, and other applicable legislations.

Qualifications

Education Requirements

• University degree in science or equivalent experience
• Post-graduate Certificate in Regulatory Affairs, preferred
• Minimum of 2-4 years of work experience in Canadian Regulatory Affairs
• Digital literacy in Microsoft Office
• Ability to acquire & maintain Criminal Record Check required for Controlled Drugs and Substance Licence

Competencies Required

• Ability to manage and maintain compliance to regulations, policies and guidance documents
• Excellent organizational, time-management and problem-solving skills
• Excellent communication (written and verbal) and strong interpersonal skills
• Attention to details

Role Dimensions

• Liaise and support various departments at site for regulated products and oversee processing of orders and shipping of regulated products
• Operations, Packaging and Logistics Department for management of all regulated inventory
• Record keeping and management of regulated inventory

Additional Information

About LGC

LGC is a leading, global life science tools company, providing critically important components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality, and range.

Our values

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

Equal opportunities

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or parental status, religion, or belief. Short listing, interviewing and selection will always be carried out without regard these factors.

For more information about LGC, please visit our website www.lgcgroup.com

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