Lead Regulatory Consultant
3 months ago
**Job Overview**
The Lead Consultant--Regulatory role focuses on maximizing and protecting the commercial interests of our clients. Our consultants often work closely with marketing, quality assurance, project management and legal teams, so that drug development, filing of submissions and maintenance of product compliance activities are undertaken in a timely manner.
In this broad-based role, you will drive the registration of various products according to applicable regulations. The role specifically prioritizes, plans and organizes regulatory-related projects to ensure smooth implementations. The role may involve coordinating the work of several consultants.
Knowledge and experience in the following are required:
- Driving product submissions to Health Canada is required
- NHP Class III PLAs - Research and Author Safety and Efficacy summaries
- Prepare and submit NHP PLAs for Amendments, Notifications and Product Licence transfers
- Review clinical and non-clinical studies and assess possibility of claims/claims substantiation
- Perform Promotional Material Review (All categories - OTC, Prescription, NHPs, Devices), and should have working knowledge of PAAB guidelines
- Prepare and submit Cosmetic Notifications and Amendments
- Perform Label reviews for Drugs, NHPs, Cosmetics
- Evaluate Regulatory product classification and develop pathways
- Prepare and submit DIN-A Labelling Standard, DIN-F Category IV Monograph, DIN-D Labelling Standard, Level III PDC submissions (PDCs)
- Assist with Product Lifecycle Management for Division 1 and 8 drugs
- Assess and manage post-market product changes along with product lifecycle
- Open to learning and working in new area like Environmental Compliance (CEPA and relevant Regulations)
- Respond to clarifications from Health Canada within the specified time frame
Knowledge and experience in the following is preferred:
- Compile and manage Drug Establishment License, Medical Device Establishment Licence and Site License
- Pharmacovigilance experience
- Health Canada Class II, III and IV Medical Device Applications
- Structured Product Labelling (SPL) working experience
- Working knowledge of Environment Compliance like implementation of Environment Management Plan (ECCC)
You will be reporting to the Manager, Regulatory Services. You will also be required to maintain up-to-date knowledge of regional and national regulations, guidelines, and advisory documents, along with advances in relevant scientific fields.
**Requirements**:
A minimum of a Bachelor of Science degree is required, along with 5-8 years of relevant industry experience. RAC Designation preferred.
**Benefits**
**Job Types**: Full-time, Permanent
Pay: Up to $85,000.00 per year
**Benefits**:
- Dental care
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care
Flexible language requirement:
- French not required
Schedule:
- 8 hour shift
- Monday to Friday
Ability to commute/relocate:
- Mississauga, ON L5N 1V8: reliably commute or plan to relocate before starting work (required)
Application question(s):
- Would you have a valid drivers' licence and be using own means of transport?
Work Location: In person
-
Associate Director
7 months ago
Mississauga, Canada Intertek Full time**How you will make an impact at Intertek**: Identify new target customers and new opportunities within existing customer base. Establish and maintain regulatory relationships with key clients as well as internal and government stakeholders, to promote Intertek’s mission and values of total quality assurance and scientific excellence. Effectively utilize...
-
Global Scientific and Regulatory Affairs Intern
6 months ago
Mississauga, Canada Ingredion Canada Corporation Full time**The major responsibilities of this role include**: Design and lead a special project as assigned. This may include a deep dive of one of Health Canada consultations and/or a comparison between current and proposed regulatory updates. Support the team in regulatory and technical presentations for the business and create training material for the G2M...
-
Regulatory Affairs Associate
6 months ago
Mississauga, Canada Mint Pharmaceuticals Inc. Full timeJob description Canadian-owned and operated, Mint Pharmaceuticals Inc. ("Mint") is a leading manufacturer of high-quality and affordable generic pharmaceutical products. With a focus on consistent supply, innovation and exceptional customer service, Mint aims to deliver the highest value to patients across Canada. Mint has repeatedly been recognized as one...
-
Regulatory Program Director Lead
2 weeks ago
Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full timeOverviewF. Hoffmann-La Roche Gruppe is a global healthcare leader with a strong presence in Canada, where we employ over 850 employees at our Mississauga facility.We are committed to innovation, curiosity, and diversity, which has enabled us to become one of the world's leading research-focused healthcare groups.The OpportunityWe are seeking a highly skilled...
-
Medical Device
6 months ago
Mississauga, Canada Diploma Healthcare Group Full timeThe Company is part of the Diploma Healthcare Group (DHG) which is a group of specialized medical device distribution companies operating in Canada, Australia, New Zealand and Ireland. DHG is owned by Diploma PLC, a public company traded on the London Stock Exchange with a market cap in excess of £1.1B. **Somagen Diagnostics Inc.** was founded +30 years...
-
Lead Consultant
3 weeks ago
Mississauga, Canada Open Text Corporation Full time**Hiring Manager**: Glenn Lautenbacher **Talent Acquisition Advisor**: Chitra Menon **Job Code Level**: CGP4 Refer Your Friends! YOUR IMPACT A Lead VIM Consultant role at OpenText is more than just a job, it's an opportunity to impact lives. As a key contributor, you'll be instrumental on implementing OpenText’s Vendor Invoice Management solution for...
-
Regulatory Affairs Associate
6 months ago
Mississauga, Canada Amgen Full timeCareer Category Regulatory **Job Description**: HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is...
-
Regulatory Affairs Manager
6 months ago
Mississauga, Canada AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...
-
Regulatory Affairs Associate
6 months ago
Mississauga, Canada Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...
-
Regulatory Affairs Specialist
2 months ago
Mississauga, Canada CONAGRA Full timeConagra Brands is one of North America's leading branded food companies. We have a rich heritage of making great food, and a team that’s passionate about innovation and growth. Conagra offers choices for every occasion through iconic brands, such as Hunts, Aylmer, Marie Callender's®, Healthy Choice®, Slim Jim®, VH Sauces, Pogo and Vlasic®, and emerging...
-
Program Lead, Clinical Regulatory Writing, Vaccines
6 months ago
Mississauga, Canada AstraZeneca Full timeThe Vaccine & Immune Therapies (V&I) unit has been created with the ambition to develop and deliver vaccines and antibodies that transform our ability to prevent and treat infectious disease. The creation and growth of this unit reflects AstraZeneca’s strong dedication to advance our transformative science for the benefit of patients worldwide. We are now...
-
Regulatory Manager
6 months ago
Mississauga, Canada Myant Full time**About Us**: At Myant, we are creating the world’s first expressive and continuous digital presence platform, enabled by integrating technology directly into clothing and augmented by other devices, wearables, and IOT. We see the evolution of society where every member gets to participate from anywhere and anytime through a whole-body experience, mostly...
-
Regulatory Affairs Clinical Trials Associate
4 weeks ago
Mississauga, Canada AstraZeneca Full time**About Our Company**: At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, daring thinking, and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees...
-
Regulatory Affairs Specialist
3 weeks ago
Mississauga, Ontario, Canada BAXTER Full timeJob DescriptionAt Baxter, we believe that our work improves outcomes for millions of patients. As a Senior Regulatory Affairs Associate, you will play a vital role in the local implementation of regulatory strategies and ensure compliance with Health Canada requirements.About the RoleThis is an exciting opportunity to join our team as a Senior Regulatory...
-
Regulatory Affairs Director
6 months ago
Mississauga, Canada AstraZeneca Full timeAt **AstraZeneca**, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within **Oncology...
-
Manager, Regulatory
6 months ago
Mississauga, Canada IMS Full timeWorking with us you’ll have a unique opportunity to experience the evolving technological frontier! **Job Purpose** **Duties and Responsibilities** Specifically, but not limited to: - Develop, implement and maintain a comprehensive quality management system and processes in accordance with applicable regulatory requirements (e.g., FDA QSR, ISO 13485,...
-
Regulatory Program Director Lead
3 weeks ago
Mississauga, Ontario, Canada Roche Full timeCompany OverviewRochefosters a culture of diversity, equity and inclusion, reflecting the communities we serve. As a leading research-focused healthcare group, we believe that understanding people's varied healthcare needs is key to success.We're driven by a passion for exceptional care and a commitment to advancing science. Our goal is to create a world...
-
Director Regulatory Intelligence
6 months ago
Mississauga, Canada AstraZeneca Full timeDo you have **competitive** **intelligence** skills and in-depth knowledge about **Regulatory Affairs**? Do you want to work on **innovative projects** of high importance for our **Respiratory and Immunology **portfolio? At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transform patient outcomes. This means our...
-
Mississauga, Canada Q&C Full timeThe Quality Assurance Specialist - Pharmaceutical role is a "Lead or Senior Consultant" position at Q&C. This pharmaceutical consultant role focuses on applying your GMP knowledge and experience to various projects, such that the client is confident in the approach and timing of execution of the project. Our consultants work independently within a team...
-
Regulatory Compliance Specialist
2 weeks ago
Mississauga, Ontario, Canada F. Hoffmann-La Roche AG Full timeOverviewF. Hoffmann-La Roche AG is a leading research-focused healthcare group, pushing the frontiers of healthcare globally.About the RoleWe are seeking an experienced Associate Regulatory Program Director to join our Pharma Technical Regulatory team in Mississauga, Ontario.Job SummaryThis role involves handling Health Authority interactions for CMC...