Regulatory Affairs Specialist
The Regulatory Affairs Specialist assists in obtaining and maintaining government approval for natural health products, cosmetics, drugs, medical devices, and related materials for clients of Source Nutraceutical Inc. Under direction of the Director of Regulatory Affairs, on behalf of client initiatives, liaises with government officials; evaluates scientific evidence and claims in support of regulatory and/or marketing applications; completes formulation and/or label reviews; and, and prepares reports and responses on projects in the field of natural health products, cosmetics, drugs, and medical devices.
Tasks will include:
- Supporting the Director of Regulatory Affairs in planning, managing, and executing regulatory reviews and general consulting requests on behalf of clients.
- Assisting the Director of Regulatory Affairs in maintaining necessary vendor and trade relationships, consistent with the objectives, operating philosophy and desired image of Source Nutraceutical, Inc.
- Compiling, preparing and reviewing Health Canada regulatory submissions for registration of natural health products, medical devices, drugs and cosmetics as well as responding to government inquiries
- Coordinating requests for (and receipt of) regulatory and quality assurance data requirements from clients.
- Effectively interpreting, applying, and clearly communicating relevant Canadian regulations and policies both to clients and fellow Team members.
- Recognizing and understanding critical components and processes of relevant regulatory applications.
- Evaluating scientific evidence to support claim portfolios within regulatory applications and/or marketing materials.
- Reviewing technical quality documents (i.e. batch records, certificates of analysis and specification sheets) for completeness, accuracy and regulatory compliance; identifying errors, missing information and deviations; reviewing laboratory and stability results and OOS [out-of-specification] results (where applicable); confirming product releases and product stability, comparing results to current specifications to assure product quality; and using the information to complete regulatory applications.
- Identifying priorities and key issues in complex situations and achieving resolution with minimal assistance.
- Meeting or exceeding all budget objectives for all assigned projects as established through the estimating process and as approved by the Director of Regulatory Affairs.
- Ensuring that the Regulatory Affairs tasks are performed in compliance with regulations established by Health Canada or other applicable country authority and within the quality assurance standards of Source Nutraceutical, Inc. and to the satisfaction of the clients.
- Maintaining client’s records and documentation generated on behalf of the clients in an organized manner and according to the procedures set out by the company.
- Striving continually to maintain state of the art technical knowledge of the business and industry while keeping abreast of government regulations.
Required: Bachelor’s Degree (B.Sc.) in Sciences
Preferred: Masters Degree (M.Sc.) or PhD. in Sciences
A minimum of two to five years experience in a regulatory field relating to Natural Health Products or Over-the-Counter (OTC) drug industry in Operations, Quality Assurance, Quality Control or testing environment.
Skill, Knowledge and Abilities:
Skills and knowledge to identify priority and operational problem areas. The ability to solve problems, execute policies and procedures on projects assigned. Solid understanding of Canadian regulations for medical devices, natural health products and drugs.
Ability to move freely around the facility. Ability to listen, actively participate in and communicate effectively with employees, customers, suppliers and government officials.
Basic statistical and analytical scientific skills, as well as excellent reading, writing and spelling ability to communicate clearly and effectively in the English language (bilingualism preferred) on all technical and business levels.
Office, laboratory, and warehouse environments.
Opportunity for remote working conditions if residing outside Manitoba.
Sales Manager - Creative Services
Are you a motivated sales hunter who enjoys winning the sale through relationship-building and creative solutions?
- You are a seasoned sales professional with a hunter mentality. You are skilled at generating your own leads through cold calling, blitzing, research, networking, and driving your territory.
- You are tenacious. Our sales cycle can be on the longer side, so you must be willing to work accounts until the client has a need.
- You enjoy building relationships and creating a bond and rapport with clients.
- You have killer time management skills. Our Sales Managers enjoy a great sense of autonomy. In order to be successful, you must organize and balance your activities appropriately (prospecting, selling, and account management) to create results.
- You have an existing book of clients, contacts to call on and introduce to our Creative Services.
Source Nutraceutical has an excellent opportunity for results driven individual for our SNI Creative Services division.
Responsibilities include but are not limited to:
- Developing and implementing a business plan and strategy for achieving sales growth and profitability
- Make recommendations for marketing plans
- Implementing and managing weekly sales call reports and discuss accordingly with Executive Team
- Assist in the development of all marketing materials, programs, website, and social media.
- Min 5-10 years Sales Management experience within the Creative Services industry.
- Min 5-10 years B2B sales experience within Creative Services industry.
- Superior coaching, decision-making, facilitation, communication, and presentation skills
- Must be innovative, possess strong analytics skills and strong market forecasting understanding.
- Must be willing to roll up sleeves and lead by example.
Position offers: Competitive Compensation, Benefits, Bonus, Opportunity to work with leading edge technology.
Please send your resume: email@example.com by June 15, 2022.