Regulatory Affairs Associate
5 months ago
Career 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 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 cross-functional 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.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- 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 sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and annual company-wide 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.
.
-
Regulatory Affairs Associate
5 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 Associate
5 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 Affairs Operations Associate
5 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 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...
-
Regulatory Affairs Specialist
5 months 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...
-
Regulatory Affairs Specialist
1 day 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 Associate Canada
5 months ago
Mississauga, Canada Ryvis Pharma Full time**The Regulatory Affairs Associate is responsible for planning, coordinating, compiling, submitting, obtaining approval, maintaining drug product registrations for Canada and the U.S. and assisting global drug product registrations.**: **Type**: 12-month Contract with an opportunity to convert to full-time based on performance. **Location**: Mississauga,...
-
Regulatory Affairs Associate, Co-op/new Grad
2 months ago
Mississauga, Canada Boston Scientific Corporation Full time**Work mode**: **Onsite Location(s)**:Mississauga, ON, CA**Additional Locations**: Canada-ON-Mississauga; Canada-ON-Toronto**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...
-
Regulatory Affairs Associate
5 months ago
Mississauga, Canada 837 GlaxoSmithKline Inc. Full timeKey Accountabilities/Responsibilities: Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area. Accountable for a portfolio of products, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc) to aggressive targets. ...
-
Regulatory Affairs Associate, Co-op/new Grad
2 months ago
Mississauga, Canada Boston Scientific Corporation Full time**Posted Date**: - Sep 23, 2024**Workmode**: - Hybrid**Additional Locations**: Canada-ON-Mississauga; Canada-ON-Toronto **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...
-
Regulatory Affairs Manager
1 month ago
Mississauga, Ontario, Canada Alectra Utilities Inc. Full timeRegulatory Affairs ManagerJob SummaryThe Regulatory Affairs Manager provides leadership and support to the Regulatory Affairs department, ensuring compliance with industry regulations and government codes. This role involves reviewing and assessing emerging regulatory issues, industry standards, and government initiatives, and providing advice and guidance...
-
Director, Standards and Regulatory Affairs
5 months ago
Mississauga, Canada The Portage Group Full time**Position Summary** Our client, the **Heating, Refrigeration and Air Conditioning Institute of Canada** (HRAI) is seeking a Director of Standards and Regulatory Affairs. This position will oversee HRAI’ s manufacturers division and execute HRAI’s standards and regulatory affairs work. The role will have a significant focus on harmonization with U.S. &...
-
Regulatory Affairs Intern
6 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 Specialist
6 months ago
Mississauga, Canada Cardinal Health Full timeCardinal Health Canada, with over 1300 employees nationwide, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country. Cardinal Health Canada is currently seeking a Regulatory Affairs Specialist to join the Regulatory Affairs and Quality Assurance team...
-
Regulatory Affairs Project Manager
1 month ago
Mississauga, Ontario, Canada Juno Pharmaceuticals Full timeRegulatory Affairs Project ManagerA Regulatory Project Manager at Juno Pharmaceuticals plays a crucial role in ensuring the successful growth and maintenance of the company's product portfolio. This position involves effectively preparing and managing assigned Regulatory Affairs projects to meet regulatory requirements and ensure compliance.Key...
-
Regulatory Affairs Specialist
4 weeks ago
Mississauga, Ontario, Canada Brenntag Specialities Full timeAt Brenntag Specialities, we are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mississauga. This role is responsible for providing support to the organization in maintaining compliance and addressing needs related to new and existing business as they pertain to regulatory matters.Key ResponsibilitiesManage risk considering legal...
-
Regulatory Affairs Specialist
1 month 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...
-
Regulatory Affairs Project Lead
1 week ago
Mississauga, Ontario, Canada Juno Pharmaceuticals Full timeA challenging opportunity has arisen at Juno Pharmaceuticals for a Regulatory Affairs Project Lead to oversee the management and preparation of assigned projects. This role is critical in ensuring the successful growth and maintenance of our product portfolio in a fast-paced environment.Responsibilities:Independently manage Regulatory Affairs projects,...
-
Regulatory Affairs Specialist
4 weeks ago
Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full timeKey Responsibilities:Develop and implement regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Prepare and submit regulatory documents, including NDSs, SNDSs, CTAs, and NCs, to achieve aggressive targets.Build and maintain relationships with Health Canada contacts to improve submission approval times and achieve...
-
Translational Regulatory Affairs Director
5 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...