Director, Regulatory Affairs

About the Business

Our client exists to re-engineer nature’s pantry, reimagine human nutrition, and revitalize wellness and the

environment. They believe there has never been a more critical need to evolve health ingredients for human

nutrition and related industries using the power of science and nature to build a more sustainable and healthier

world. Their remarkable journey has transformed from a research & development startup into a global leader within

the algal omega-3 oil industry, encompassing pivotal sectors such as food, beverage, and infant nutrition. Their

commitment to commercializing unique patent-protected technologies, coupled with the expertise of a diverse

team of exceptional research scientists specializing in biology, fermentation, extraction, product quality, and

analytical chemistry, has been the driving force behind their expansion.

The Position

The Director, Regulatory Affairs is responsible for ensuring regulatory compliance of current products in existing

markets, reporting on regulatory changes that may impact our clients business, and ensuring the regulatory

strategy supports the business' growth objectives.

Duties and Responsibilities:

• To provide deep expertise in the field and determine regulatory requirements for new and current

products

• Provide strategy, timelines and costs for regulatory approvals/registrations/licenses

• Build and execute a strategy that supports business growth objectives

• Compile competitive intelligence and maintain market awareness to inform regulatory and business

strategy

• Support business growth by (i) supporting established regional teams with deep expertise, and

(ii) addressing customers directly as required from time to time

• Support new product development and continuous improvement and ensure regulatory approvals are

in place/compliance is maintained

• Maintain awareness of changing regulatory environments in which our client operates and report on

regulatory risks and opportunities impacting the business

• Represent the company in discussions with global regulatory authorities

• Support the execution of the company’s recall plan in case of product recall and

withdrawal including communication with authorities

• Take part in customer meetings as required

• Participate in organizational meetings and training as required

• Other duties as required.

Education and Experience:

• Post-secondary degree in science or engineering discipline

• Minimum of 10 years regulatory experience, including a minimum of 5 years of management

experience

• Experience with food/supplements, pharmaceutical or medical devices considered an asset.

Required Skills and Competencies:

• Ability to influence

• Deep global regulatory knowledge for regulated health and nutrition products

• Strong communication skills and ability to negotiate

• Deep technical knowledge of common manufacturing and quality processes in food, supplement and

omega-3 industries

• Ability to distill complex information into an executive summary

• Ability to work in and excel under high stakes situations (product safety recalls, dealing with

regulatory authorities on non-conformities, making product safety decision, etc.)