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Regulatory Affairs Associate

3 months ago

Mississauga, Ontario, Canada Amgen Full time
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 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.

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 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.