Current jobs related to Regulatory Affairs Associate - Mississauga, Ontario - Amgen
-
Regulatory Affairs Associate Intern
1 month ago
Mississauga, Ontario, Canada GlaxoSmithKline Full timePosition Overview: As a Regulatory Affairs Associate Intern, you will play a crucial role in supporting the Therapy Area teams with the organization and execution of regulatory submissions, including Clinical Trial Applications (CTA), New Drug Submissions (NDS), and related compliance initiatives.Key Responsibilities: - Collaborate with various local and...
-
Regulatory Affairs Specialist
21 hours ago
Mississauga, Ontario, Canada GSK Full timeJob Title: Regulatory Affairs Associate/Project LeaderWe are seeking a highly skilled Regulatory Affairs Associate/Project Leader to join our team at GSK. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with Health Canada regulations and guidelines.Key Responsibilities:Develop and implement regulatory...
-
Regulatory Affairs Specialist
24 hours ago
Mississauga, Ontario, Canada GSK Full timeJob Title: Regulatory Affairs Associate/Project LeaderWe are seeking a highly skilled Regulatory Affairs Associate/Project Leader to join our team at GSK. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with Health Canada regulations and guidelines.Key Responsibilities:Develop and implement regulatory...
-
Regulatory Affairs Specialist
1 month ago
Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full timeF. Hoffmann-La Roche Gruppe values diversity, equity, and inclusion, reflecting the communities we serve. In the realm of global healthcare, diversity is a crucial element for success. We believe that inclusion is vital for understanding the diverse healthcare needs of individuals. Together, we celebrate uniqueness and share a commitment to outstanding...
-
Regulatory Affairs Specialist
1 month ago
Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full timeF. Hoffmann-La Roche Gruppe values diversity, equity, and inclusion, reflecting the communities we serve. In the realm of global healthcare, diversity is crucial for success. We believe that inclusion is essential for understanding the diverse healthcare needs of individuals. Together, we celebrate uniqueness and share a commitment to outstanding...
-
Regulatory Affairs Specialist
7 hours ago
Mississauga, Ontario, Canada GlaxoSmithKline Full timeJob Title: Regulatory Affairs Associate/Project LeaderAt GlaxoSmithKline, we are seeking a highly skilled Regulatory Affairs Associate/Project Leader to join our team. This role will play a pivotal part in shaping the future of healthcare in Canada by ensuring that our Canadian regulatory requirements are met and exceeded.Key Responsibilities:Develop and...
-
Regulatory Affairs Specialist
2 hours ago
Mississauga, Ontario, Canada GlaxoSmithKline Full timeJob Title: Regulatory Affairs Associate/Project LeaderAt GlaxoSmithKline, we are seeking a highly skilled Regulatory Affairs Associate/Project Leader to join our team. This role will play a pivotal part in shaping the future of healthcare in Canada by ensuring that our Canadian regulatory requirements are met and exceeded.Key Responsibilities:Develop and...
-
Regulatory Affairs Specialist
1 month ago
Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full timeCompany OverviewF. Hoffmann-La Roche Gruppe is committed to fostering diversity, equity, and inclusion, reflecting the communities we serve. We recognize that diversity is vital for success in the global healthcare landscape. Inclusion is essential for understanding the diverse healthcare needs of individuals. At Roche, every voice is valued, and we share a...
-
Regulatory Affairs Specialist
6 days ago
Mississauga, Ontario, Canada GlaxoSmithKline Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Associate/Project Leader to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will play a pivotal role in shaping the future of healthcare in Canada.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with Health Canada and...
-
Regulatory Affairs Specialist
6 days ago
Mississauga, Ontario, Canada GlaxoSmithKline Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Associate/Project Leader to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will play a pivotal role in shaping the future of healthcare in Canada.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with Health Canada and...
-
Regulatory Affairs Associate, Co-op
11 hours ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Regulatory Affairs Associate to support our Regulatory Affairs Manager with various regulatory activities.This is a 12-month co-op/new grad placement that will provide you with the opportunity to gain hands-on experience in regulatory affairs and develop your skills in a dynamic and...
-
Regulatory Affairs Associate, Co-op
6 hours ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Regulatory Affairs Associate to support our Regulatory Affairs Manager with various regulatory activities.This is a 12-month co-op/new grad placement that will provide you with the opportunity to gain hands-on experience in regulatory affairs and develop your skills in a dynamic and...
-
Regulatory Affairs Specialist
3 days ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleThe Regulatory Affairs Associate supports the Regulatory Affairs Manager with various regulatory activities, ensuring compliance with industry standards and company policies.Key ResponsibilitiesMaintain accurate and up-to-date regulatory documentation and records.Assist in preparing and compiling submissions and routine reports to regulatory...
-
Regulatory Affairs Specialist
3 days ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleThe Regulatory Affairs Associate supports the Regulatory Affairs Manager with various regulatory activities, ensuring compliance with industry standards and company policies.Key ResponsibilitiesMaintain accurate and up-to-date regulatory documentation and records.Assist in preparing and compiling submissions and routine reports to regulatory...
-
Regulatory Affairs Specialist
3 weeks ago
Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full timeJob Summary:As a Regulatory Affairs Associate at 837 GlaxoSmithKline Inc., you will play a critical role in ensuring the company's products meet regulatory requirements and are approved for market access. This position requires a strong understanding of Canadian regulations and guidelines, as well as excellent communication and project management skills.Key...
-
Regulatory Affairs Specialist
2 weeks ago
Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 837 GlaxoSmithKline Inc. as a Regulatory Affairs Associate. This role will be responsible for developing and implementing regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Key ResponsibilitiesDevelop and implement regulatory...
-
Regulatory Affairs Specialist
2 weeks ago
Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 837 GlaxoSmithKline Inc. as a Regulatory Affairs Associate. This role will be responsible for developing and implementing regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Key ResponsibilitiesDevelop and implement regulatory...
-
Regulatory Affairs Specialist
2 weeks ago
Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 837 GlaxoSmithKline Inc. as a Regulatory Affairs Associate. This role will be responsible for developing and implementing regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Key ResponsibilitiesDevelop and implement regulatory...
-
Regulatory Affairs Specialist
2 weeks ago
Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 837 GlaxoSmithKline Inc. as a Regulatory Affairs Associate. This role will be responsible for developing and implementing regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Key ResponsibilitiesDevelop and implement regulatory...
-
Regulatory Affairs Specialist
1 week ago
Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full timeKey Accountabilities/Responsibilities:As a Regulatory Affairs Associate at 837 GlaxoSmithKline Inc., you will be responsible for developing and implementing regulatory strategies to ensure compliance with Health Canada and industry guidelines. Your key responsibilities will include:Developing and executing regulatory plans to achieve rapid approvals and...
Regulatory Affairs Associate
3 months ago
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 leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Regulatory Affairs Associate
Live:
What you will do
Let's do this. Let's change the world.
In this vital role you will perform local coordination and execution of Regulatory submissions in compliance with corporate standards and local Regulatory requirements under the direction of a Senior Manager.
Responsibilities:
- Execution of the preparation, delivery, and electronic archiving of documentation for inclusion in local Regulatory submissions.
- Coordination and execution of Regulatory Affairs processes and deliverables in the local office.
Regional Specific Activities:
- Ensure Regulatory submissions are made on time and meet Amgen's corporate and local Regulatory requirements.
- Contribute to and implement filing plans, where applicable.
- Review source text for country labelling.
- Disseminate relevant information to team(s) as appropriate.
- Participate in local Regulatory process improvement initiatives.
- Assist locally in Healthcare Compliance activities, where applicable.
- Collate, distribute, exchange, and review Regulatory information with other Regulatory colleagues and crossfunctional teams on an ongoing basis and provide advice on local Regulatory considerations in a timely manner.
- Review translations for local Regulatory submissions.
- Partner with International Regulatory Leads (IRLs) to support the Regulatory development, registration, and lifecycle management of all Amgen molecules.
- Health Authority Interactions.
- Under general supervision, interact with local health and Regulatory authorities for routine matters.
Win:
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The detail oriented professional we seek is a teammate with these qualifications.
Basic Qualifications:
Bachelor's degree
Or:
Associate's degree and 4 years of regulatory affairs experience
Or:
High school diploma / GED and 6 years of regulatory affairs experience
Preferred Qualifications:
- 1+ year of Regulatory affairs experience
- Regulatory Certificate
- Knowledge of Regulatory principles
- Working with policies, procedures and SOP's
- Knowledge of national legislation and regulations relating to medicinal products
- Knowledge of drug development
- Scientific / Technical excellence
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and prevent potential issues
- Understanding of Regulatory activities and their touch points
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both regional country and International borders
Thrive:
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans and annual companywide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished p