Scientific Regulatory Affairs Consultant / Toxicologist

Scientific Regulatory Affairs Consultant / Toxicologist

August 10, 2021 By

Introduction:

Welcome to dicentra!

We are a diverse team from a wide range of industries and backgrounds all united by one common passion: to improve the health and wellness of people around the world. Whether we are developing and executing a break-through clinical trial, issuing the required certifications to sell a product in a new country or jurisdiction, or guiding a client to help them successfully navigate through regulatory hurdles, we do it with confidence, knowing that our team is backed by incredible and wide-ranging experience and one of the highest success rates in the business. If you share our passion for improving health and wellness and want to find purpose in your work, apply now and join one of North America’s most respected brands in both the Health Sciences and Food industries.

Let’s build a better world, together!

Why join us

Best workplace
We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences.

Best people
We unite cross-industry professionals with a shared passion for improving people’s health and wellness. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives.

Best opportunities
We encourage our team members to continuously develop and enhance their skills and expertise. We recognize and reward courageous choices and innovative ideas that result in the growth of our people and company, and in the success of our clients.

Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide!

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 ensuring 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

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.