Associate, Regulatory Affairs

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Title: Associate, Regulatory Affairs

Reports to: Senior Manager, Regulatory Affairs

Location: Mississauga Flexible Commuter

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:

• Execute the preparation, delivery, and electronic archiving of documentation for inclusion in local Regulatory submissions.
• Partner with International Regulatory Leads (IRLs) and cross-functional team members to support the coordination and execution of local Regulatory submissions.
• Coordination and execution of Regulatory Affairs processes and deliverables to ensure submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
• Disseminate and exchange relevant information to team(s) as appropriate.
• Contribute to and support implementation of filing plans, where applicable.
• Support local labelling activities, including the review of source text and translations for country labelling.
• Participate in local Regulatory process improvement initiatives.
• Under general supervision, interact with local Health and Regulatory authorities for routine matters.
• Ensure/support regulatory product compliance (e.g. Health Canada commitments).
• Partner with peers to ensure consistency in implementation of local policies and procedures.

Core Competencies

• Knowledge of drug development
• Knowledge of regulations, guidelines and regulatory principles
• Knowledge of the registration procedures in Canada for clinical trial applications, marketing applications and post-approval changes
• Scientific / Technical excellence

• Adherence to policies, procedures, and standard operating procedures (SOPs)
• Effective communication
• Cross-functional collaboration and teamwork
• Flexibility and adaptability
• Demonstrates strong initiative and attention to detail

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.

Basic Qualifications:

• Bachelor of Science degree
• Regulatory affairs experience

Preferred Qualifications:

• 1+ year of Regulatory affairs experience
• Regulatory Affairs Graduate Certificate
• Ability to understand and communicate scientific/clinical information
• Ability to anticipate and prevent potential issues
• Understanding of Regulatory activities and their touch points

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.Amgen is proud to have been recognized as one of LinkedIn Top 25 Companies in Canada for career growth. Click HERE for more details. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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 people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.