Regulatory Affairs Specialist

2 weeks ago

Mississauga, Canada Cliantha Research Ltd. Full time

**Job Description / Roles and Responsibilities for Job Title**:
**1)** Maintain an excellent knowledge of clinical trials/clinical research and a thorough understanding of industry regulatory requirements

**2)** Stay current on regulatory updates and issue regular communications bulletins within the organization

**4)** Communication with the regulatory agencies (e.g., Health Canada, EMEA, FDA) and/or via the sponsor in response to regulatory issues raised in regulatory documents such as clarifaxes or deficiency letters

**5)** Conduct and support all other Regulatory submissions, including but not limited to, SAEs, End of Study Notifications, Amendments, responses to clarifaxes and/or other submissions queries/questions/observations, etc.

**8)** Completion of Bioequivalence Summary Tables and Comprehensive Summary - Bioequivalence Report for Submission to regulatory authorities

**9)** Creation and maintenance of regulatory resources for the company with respect to the following regulatory bodies: Health Canada, FDA, EMEA, MHRA; others as needed

**10)** Register appropriate clinical trials with ClinicalTrials.gov as per FDAAA 801 requirements

**11)** Provide regulatory advice and input as required

**12)** Work in a safe manner that does not endanger yourself or co-workers

**13)** Delegate tasks as appropriate to members within the regulatory team in order to meet timelines efficiently

**14)** Preparation of other submissions not identified above, if/as requested (i.e. Ethics, etc.)

**15)** Execute other duties as required by RA Management
- **Any Additional responsibility given by Head of the Department / Management**_

**Qualifications**:

- Bachelor of Science (B.Sc.) degree in life sciences
- Post-graduate Regulatory Affairs certification an asset
- Minimum 1-3 years regulatory affairs experience within the pharmaceutical/CRO industry
- Current with regulatory requirements pertaining to clinical research (Health Canada, FDA), ICH, GCP, GDP, GMP, GLP, Code of Federal Regulations (21CFR)
- Experience associated with the conduct of activities pertaining to registrations and submissions with Health Canada, FDA (IRBs an asset)
- Possess a highly developed regulatory mindset as it pertains to BE and phase I-IV clinical trials
- Strong analytical and problem solving skills
- Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
- Excellent interpersonal skills
- Strong written and verbal communication skills

**Salary**: $45,000.00-$80,000.00 per year

**Benefits**:

- On-site parking

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Mississauga, ON L4W 1A4: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

Work Location: In person

  • Quality Assurance

    4 weeks ago

    Mississauga, Canada Hansamed Ltd. Full time

    **Quality Assurance & Regulatory Affairs Specialist position** HANSAmed is a specialty Cell-Tissue-Organs, Medical Device, and pharmaceutical distributor. We are committed to providing exceptional service and brand awareness to thousands of hospitals, dental and oral surgery clinics that we serve in Canada, the United States and around the world. HANSAmed...

  • Regulatory Affairs Specialist

    4 weeks ago

    Mississauga, Canada Profound Medical Full time

    Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic,...

  • Regulatory Affairs and Quality Specialist

    4 weeks ago

    Mississauga, ON, Canada Juno Pharmaceuticals Full time

    The Quality & Compliance Specialist jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC’s drug products. The candidate will support the Manager, Quality in leading the operational oversight, decision making and performance of...

  • Regulatory Affairs Manager

    5 days ago

    Mississauga, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association...

  • Regulatory Affairs Manager

    5 days ago

    Mississauga, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association...

  • Regulatory Affairs Manager

    5 days ago

    Mississauga, Canada The Portage Group Full time

    Company DescriptionThe Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...

  • Regulatory Affairs Manager

    2 days ago

    Mississauga, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...

  • Regulatory Affairs Intern

    5 days ago

    Mississauga, Canada GE Healthcare Full time

    **Job Description Summary**: The Regulatory Affairs Intern will be involved in Premarket and Compliance duties. They will work with a team of Regulatory Affairs professionals and provide support to ensure GEHC establishes and implements best practice processes and procedures in premarket support. **Key responsibilities/essential functions include**: - **...

  • Regulatory Affairs Manager

    3 days ago

    Mississauga, Canada The Portage Group Full time

    Company DescriptionThe Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...

  • Regulatory Affairs Manager

    6 days ago

    Mississauga, Canada The Portage Group Full time

    Company DescriptionThe Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...

  • Regulatory Affairs Manager

    6 days ago

    Mississauga, Canada The Portage Group Full time

    Company DescriptionThe Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...

  • Regulatory Affairs Manager

    4 days ago

    Mississauga, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client . Position...

  • Regulatory Affairs Manager

    5 days ago

    Mississauga, ON, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client. Position...

  • Regulatory Affairs Manager

    6 days ago

    Mississauga, ON, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client. Position...

  • Manager, Regulatory Affairs

    4 days ago

    Mississauga, Canada Trillium Health Partners Full time

    **Job Description**: **Position**:Manager, Regulatory Affairs **Status**:Full Time **Department**:Professional Practice **Posted Date**:Monday July 10th, 2023 - July 31st, 2023 11:59 PM EDT **Salary Band**: $96,200 - $144,350 (salary band placement commensurate with experience) *** A New Kind of Health Care for a Healthier Community. That’s our...

  • Regulatory Affairs Director

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    At **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...

  • Regulatory Affairs Associate

    2 days ago

    Mississauga, Canada AstraZeneca Full time

    **Regulatory Affairs Associate** **Hybrid Work - on average 3 days/week from office** **Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees...

  • Global Scientific and Regulatory Affairs Intern

    4 weeks 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...

  • Pharmaceutical Senior Manager Regulatory Affairs

    2 days ago

    Mississauga, Canada Optimum Staffing Solutions Inc. Full time

    Our client is a dynamic, growing company and are looking for a motivated professional in Regulatory Affairs to support their growth. The Regulatory Affairs (RA) Manager will provide regulatory expertise and support for the approval and maintenance activities that should meet the Federal regulatory requirements for Canada and the United States of the...

  • Pharmaceutical Senior Manager Regulatory Affairs

    2 days ago

    Mississauga, Canada Optimum Staffing Solutions Inc. Full time

    Our client is a dynamic, growing company and are looking for a motivated professional in Regulatory Affairs to support their growth. The Regulatory Affairs (RA) Manager will provide regulatory expertise and support for the approval and maintenance activities that should meet the Federal regulatory requirements for Canada and the United States of the...