Regulatory Affairs Specialist

Main Responsibilities:

Reporting to the Plant Manager, the Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory guidelines and standards related to the manufacturing, marketing, and distribution of high-quality alcohol in Canada, the United States, and the European Union.

This role will involve maintaining up-to-date knowledge of applicable regulations and actively coordinating with internal stakeholders and external regulatory bodies. The successful candidate will play a crucial role in facilitating smooth business operations while adhering to all legal and quality guidelines.

Responsibilities:

• Monitor and interpret regulatory requirements specific to ethyl alcohol production and marketing in Canada, the United States, the European Union and possibly other jurisdictions.
• Develop and implement strategies to ensure compliance with applicable regulations, standards, and guidelines.
• Support the business in addressing regulatory hurdles with the export of products.
• Stay updated with changes in regulatory landscapes, guidelines and industry standards that may impact product compliance.
• Assess the potential impact of regulatory changes and recommend appropriate actions to maintain compliance to key internal stakeholders.
• Collaborate with cross-functional teams to address compliance issues and implement necessary corrective actions.
• Coordinate and manage the preparation of new submissions or renewals of registrations and licenses, required for the manufacture, export, and distribution of ethyl alcohol products.
• Process and maintain up-to-date records of regulatory documents, ensuring accuracy and completeness.
• Develop and maintain knowledge of requirements for storage, and transport, among other areas.
• Create and maintain SDS's utilizing a 3rd party compliance service or software where necessary.
• Create and maintain all labels for regulatory and customer quality compliance.
• Provide regulatory support for internal and external stakeholders, offer guidance and support to internal stakeholders on regulatory requirements, processes, and best practices
• Liaise with relevant regulatory bodies to address inquiries, resolve issues, and obtain necessary approvals.
• Assist in conducting internal quality and compliance audits to identify areas of improvement and ensure adherence to regulatory requirements.
• Develop and deliver regulatory training programs to employees, ensuring awareness and understanding of regulatory obligations.
• Perform related duties and responsibilities as required

Key Skills and Attributes:

• Strong knowledge of Regulatory Affairs, product safety, and transportation safety.
• Exceptional verbal and written communications, interpersonal and time management skills.
• Ability to collaborate effectively with cross-functional teams.
• Excellent problem-solving and knowledge sharing skills.
• Strong organizational ability, management of multiple priorities, and proven ability to meet strict and established timelines.
• Results oriented, self-motivated, and able to work independently as well as with a team.
• Knowledge of compliance auditing and training practices is a plus.
• Knowledge of GMP requirements and QA/QC procedures.
• Superior computer software skills (Microsoft Word, Excel, Access, PowerPoint, Adobe Acrobat, Document Management Systems).

Requirements:

• Bachelor's degree in chemistry, biology, engineering or a related field. A certificate in Regulatory Affairs is an asset.
• 7 plus years of proven experience in Regulatory Affairs within a manufacturing or distribution company.
• Strong knowledge of regulatory requirements and guidelines in one or more of the following industries: Chemicals, Pharma, Food or Personal Care.
• Working knowledge of federal/state regulations applicable to ethyl alcohol (chemical) sales and transport.
• Experience with regulatory documents including Safety Data Sheet, approval and reviewing of new products and others.
• Proven experience with the following regulations and governing bodies is necessary: TDG, WHMIS, GHS, OSHA and REACH, FDA, and Health Canada.
• Thorough knowledge of GMP regulatory compliance in addition to Regulatory/Operations experience in a GMP environment.
• Thorough understanding of regulations and guidance published by Health Canada and FDA.
• Familiarity with licensing and registration processes for alcohol-related products is considered an asset.
• Good knowledge of food safety programs.
• Ability to interpret and apply complex regulatory guidelines.

Joining our team as a Regulatory Affairs Specialist will provide you with the opportunity to contribute to the success of our company. You will play a vital role in ensuring our products meet all regulatory requirements, enabling us to maintain our excellent standards and expand our market presence.

Kawartha Ethanol offers a pleasant work environment, competitive wages & benefit package.

If you are interested in pursuing this opportunity, please email your Resume & Cover Letter stating the Position and your Salary Expectations in confidence.

NO PHONE CALLS PLEASE

We thank all who apply, but only those applicants selected for an interview will be contacted.

KEI welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

Job Types: Full-time, Permanent

Benefits:

• Dental care
• Extended health care
• On-site parking
• Vision care

Schedule:

• Monday to Friday

Education:

• Bachelor's Degree (preferred)

Ability to Commute:

• Havelock, ON K0L 1Z0 (required)

Ability to Relocate:

• Havelock, ON K0L 1Z0: Relocate before starting work (required)

Work Location: In person

Application deadline: 2024-03-01