Career Category

Job Description

Title: Sr. Associate, Regulatory Affairs

Reports to: Sr. Regulatory Manager

Location: Remote work from home

At Amgen, you'll experience a work environment where employees strive to serve patients by redefining the promise of science and biotechnology into therapies that have the power to restore health. Amgen provides a perfect combination of science and entrepreneurship that brings therapies to market by people that have a true passion for their work.

Our culture is what makes Amgen a special place to work. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Take a few minutes to hear what some of our staff members are sharing about working at Amgen!

Click HERE

Responsibilities

Strategic and Execution

• Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.

• With close supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.

• Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.

• Builds, reviews, and approves source text for country labeling, and owns the country artwork based on source text.

• Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and implementation for clinical studies in accordance with national legal and regulatory requirements

• Reviews and approves promotional and non-promotional materials.

• Tracks changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to Amgen.

• Monitors the external regulatory environment to help guide regulatory decision making.

• Ensures/supports regulatory product compliance (e.g. IMR, PMCs, pediatric and other agency commitments).
   

Communication and collaboration

• Works closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.

• Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.

• Partners with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.

• Partners with peers to ensure consistency on procedures.

• Acts as contact and builds relationships with Agency staff on specific product assignment

• Establishes regular contacts and interactions with Distributors
   

Country specific activities

• Assists locally in Healthcare Compliance activities where applicable.

• Participates in local regulatory process improvements, initiatives and training.

• Is responsible for external vendor/contractor relationships where applicable

• Acts as the point of contact with regulatory agencies in fulfilling local obligations.
   

Basic Qualifications

• BSc degree

• 2-6 years of related experience
   

Preferred Qualifications, Knowledge, and Skills

• BSc Degree and in-depth Canadian regulatory experience relating to medicinal products

• Ability to work in teams.

• Ability to understand and communicate scientific/clinical information.
   

Scientific and Technical

• Knowledge of Regulatory principles.

• Working with policies, procedures and SOP’s.

• Comprehensive understanding of regulatory activities and how they affect other projects and/or processes.

• General knowledge of national legislation and regulations relating to medicinal products.

• Understanding of drug development.
   

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, improve your expertise, and maximize your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits. Our compensation and benefits are rated above 4 stars (out of 5) on Glassdoor
   

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen endeavors to make its recruitment process accessible to any and all users. Reasonable accommodations will be provided, upon request, to applicants with disabilities in order to facilitate equal opportunity throughout the recruitment and selection process. Please contact TalentAcquisitionInquiries@amgen.com to make a request and ensure you include the requisition number.

Reasonable accommodations are available, upon request, to facilitate the equal participation of candidates with disabilities, should you be selected for an interview.