Scientific Regulatory Affairs Consultant / Toxicologist

Position: Scientific Regulatory Affairs Consultant / Toxicologist

Job Summary:

The “Scientific Regulatory Affairs Consultant / Toxicologist” is responsible for developing and implementing strategies to ensure client compliance in one or more of the following product categories: natural health products (NHPs), cosmetics, consumer products, food, drugs, medical devices, animal feed, pesticides, fertilizers, new substance notifications (NSNs), and dietary supplements with appropriate domestic and international government agency regulations. This role includes responsibility for a high-level understanding of sound scientific reviews under the appropriate jurisdiction and regulatory requirements, including safety (such as Generally Recognized as Safe (GRAS) notices, etc…) and efficacy (such as supporting claims with appropriate evidence).

Job Responsibilities:

•Compiles and reports scientific evidence to assess the safety of ingredients for use in supplement products (including NHPs, homeopathy products) including for Class I, II, and III NHP applications, and foods/ ingredients, and compiles responses for information Request Notices
• Product Classification (Canada and some focus on the US) and Strategy
• Safety/Toxicology Reports on Ingredients and Product Formulas
• Preparing GRAS submissions/support for clients / liaising with FDA
• Conducts extensive literature searches and critically reviews data in order to support the validity of unique health claims for supplements in Canada and the U.S.
• Compiling US Claim substantiation reports for Dietary Supplements, and compiling new claim options for structure function claims for US Clients
• Food Claim reviews (Canada mostly but not limited to)
• HOSU (History of Safe use reports for Canada)
• Reviewing and assessing evidence for NHP Master files, and compiling Master file applications
• Reviews pertaining to safety or efficacy of ingredients/products for clients / team-members for projects
• Compiling literature/evidence for filing Ingredient Issue Forms to be added to the NHPID (Ingredient reviews as well)
• Compiling Consumer Product Safety assessments/reports (as per CCCR 2001)
• Liaising with Health Canada to determine novelty status for ingredients (for foods)

Job Qualifications:

• Master of Science (Master in Toxicology preferred)
• 5+ years of experience working in a similar role
• Experience working for a consulting firm preferred
• Certificate in Regulatory Affairs would be an asset
• In-depth knowledge of Canadian, US, and international regulations for food, NHP, OTC, medical device, animal feed, VHP, fertilizer, pesticide, cosmetics, consumer products, and dietary supplements is a definite advantage
• Ability to review/develop, and substantiate marketing and scientific claims as appropriate to the product classification
• Ability to complete scientific safety assessments and dossiers as required for the product type (GRAS, NDIs, food additive submission, novel food, etc.) including appropriate exposure assessments for ingredient proposed uses.
• Excellent analytical abilities, critical thinking, focus on the big picture
• Understanding of risk management
• Effective attention to detail in order to successfully oversee regulatory initiatives
• Well-developed communication skills (oral, written, computer-proficient) with the ability to present ideas, solutions, and strategies in a clear and concise manner
• Excellent organizational, interpersonal, and communication skills
• Self-motivated and enjoy taking the initiative
• Monitoring budgeted hours and ensuing projects are completed in an appropriate time frame

In addition to the skills and qualifications above, we value the following qualities in all of our team members:

• High-quality standards, responsibility, and engagement
• Ability to interact with a range of personalities and many levels of the organization
• Demonstrated self-motivation and the ability to take initiative
• Project management and strong prioritization skills
• Attention to and ability to execute details
• Adaptable to changing environment, client, and project needs

Job Type: Full-time

Location: Opportunity to work remotely or in Toronto, ON office.

Benefits Include:

• Disability insurance
• Dental Care
• Extended health care
• Life insurance
• Vision care
• Wellness program
• Work remotely/optional

Location: Opportunity to work remotely or in Toronto, ON office.

Applying:

To be considered for future opportunities, please email your cover letter, resume/CV, and any related supporting documentation to hr@dicentra.com with “Scientific Regulatory Affairs Consultant / Toxicologist” in the subject line.

As part of the hiring process, in addition to interviewing, successful candidates may be required to complete a skills assessment and a reference/background check. If you are sent a skills assessment, please complete it for consideration for the advertised position.

We thank all applicants for their interest, however, only those selected for an interview will be contacted.

Inclusion:
dicentra is firmly committed to creating a welcoming, accessible, respectful, and inclusive environment at our company in all divisions. We support the safety of employees and clients of diverse backgrounds and experiences. We also strive to meet individualized accessibility to ensure full inclusion for everyone. If you are selected to proceed through the hiring process and need a reasonable accommodation, please inform the company representative that contacts you.

About dicentra:

dicentra is a contract research organization and professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries. We evaluate, implement, and provide all the necessary support for our client’s products and operations, allowing them to gain market access while building confidence in their brand.

We achieve this through our four business divisions:
Life Sciences Consulting
Food Safety & Quality Consulting
Global Certifications
Clinical Trials

Our team of experts work collaboratively to protect and improve our client’s businesses. We strive to promote a dynamic environment and encourage our team to continuously develop and enhance their skills and expertise, resulting in innovative solutions for our clients.