Regulatory Affairs Specialist
7 months ago
**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
-
Regulatory Affairs Specialist
6 days ago
Mississauga, Canada Boston Scientific Corporation Full time**Regulatory Affairs Specialist**: - Remote Eligible: Hybrid- Onsite Location(s): Mississauga, CA**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some...
-
Regulatory Affairs Specialist
5 days ago
Mississauga, Canada KIA CANADA INC Full time**Regulatory Affairs Specialist** The overall purpose of this position is to be a Canadian Regulatory Expert (Federal and Provincial) to liaise between government bodies and the Company’s factories to ensure compliance with all legislations and regulations related to all Company products. This position reports to the National Manager, Government...
-
Regulatory Affairs Specialist
2 months ago
Mississauga, Canada BD Full time**Job Description Summary**: We are** the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...
-
Regulatory Affairs Specialist
4 months ago
Mississauga, Canada ct bakery Full time_We are seeking a dedicated Regulatory Affairs Specialist - _**Food Industry**_ _to join our team. The Regulatory Affairs Manager will play a crucial role in guiding regulation strategies. This position requires strong regulatory knowledge, strategic thinking, and the ability to collaborate effectively across departments and with regulatory...
-
Mississauga, Canada Neuro Spinal Innovation Inc. Full timeThe Regulatory Affairs and Quality Assurance department is seeking an urgent hire for a **Regulatory Affairs and Quality Assurance Specialist** to provide support to register company products worldwide with a primary focus on the North American markets: FDA and Health Canada medical devices submissions. Furthermore, the Regulatory Affairs and Quality...
-
Specialist, Regulatory Affairs
2 months ago
Mississauga, Canada BAXTER Full time**This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
-
Regulatory Affairs Specialist
2 months ago
Mississauga, Canada Cerapie Pharma Inc. Full timeThe **Regulatory Affairs Specialist** is responsible for compiling, submitting, and maintaining drug product registrations for the US and Canada and assisting with global drug product registrations. **Principal Duties and Responsibilities**: - Prepare and/or review submissions to Health Canada and FDA for a variety of dosage forms (solid oral, liquids,...
-
Regulatory Affairs Specialist
4 weeks ago
Mississauga, Ontario, Canada BAXTER Full timeProduct Compliance ExpertiseWe are seeking a skilled Regulatory Affairs Specialist to join our team at Baxter, a leading healthcare company dedicated to saving and sustaining lives. This role will play a critical part in ensuring compliance with regulatory requirements for our products in Canada.About the Role:This position involves working under limited...
-
Regulatory Affairs Specialist
3 months ago
Mississauga, Canada CT BAKERY Full timeJob Overview* **Duties**: - Develop and implement regulatory strategies for product approvals - Monitor and interpret regulatory requirements and changes - Prepare and submit regulatory filings and documentation - Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle - Conduct regulatory research and...
-
Specialist, Regulatory Affairs
2 weeks ago
Mississauga, Canada BAXTER Full time**This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
-
Regulatory Affairs Specialist
3 months ago
Mississauga, Canada ct bakery Full timeThe primary focus of the role is to ensure the accuracy of the regulatory information in our databases for ingredients, allergens, formulas and labels; - Issuance of label information documents that comply with the regulations; and regulatory compliance of final product labels including product naming, ingredients, nutrition facts, claims, third party...
-
Regulatory Affairs Specialist
1 month ago
Mississauga, Canada M&M Food Market Full time**Description** **Competitive Benefits. Meaningful Extras. Unmatched Value.** - A place where you can take your career in the direction you want to grow and go - Flexible work options and summer hours for eligible employees - Save on gas at stations across Canada, including Chevron, Fas Gas, Ultramar, and Pioneer - Save on M&M Food Market products **The...
-
Regulatory Affairs Associate
7 months ago
Mississauga, Canada Bayer Full time**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Regulatory Affairs Manager, Vaccines
8 months ago
Mississauga, Canada AstraZeneca Full time**About us**: Are you passionate about **science** and experienced within **drug development** and **regulatory affairs**_? _Would you like to combine your **project management skills** with your experience of working cross functionally and globally? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’...
-
Regulatory Affairs Intern
7 months 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 Associate
7 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
4 days ago
Mississauga, Canada Bayer Full time**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Regulatory Affairs Associate
7 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
4 months ago
Mississauga, Canada CT Bakery Full timeJob Overview* **Duties**: - Develop and implement regulatory strategies for product approvals - Monitor and interpret regulatory requirements and changes - Prepare and submit regulatory filings and documentation - Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle - Conduct regulatory research and...
-
Associate, Regulatory Affairs
1 week ago
Mississauga, Canada Natco Pharma (Canada) Inc. Full time**Associate, Regulatory Affairs** Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated generic pharmaceutical company focused on research & development, and the manufacturing of active pharmaceutical ingredients (API) and finished drug product formulations. The Regulatory Affairs department is responsible...