Career Category
Regulatory
Job Description
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. 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.
US Regulatory Lead
What you will do
Let’s do this. Let’s change the world. US Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.
The Local Regulatory Representative (Manager) is assigned to one or more Amgen products, and plans and executes the Regulatory strategies for that product(s) in their country(ies). The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.
· Assist in aligning local regulatory requirements with Amgen’s corporate standards.
· Provide local input to and execute regulatory strategies.
· Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
· Provide guidance on local mechanisms to optimize product development and regulatory approvals
· Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
· Ensure and support local regulatory product compliance (eg, IMR, PMCs, and agency commitments)
· Act as the point of contact with regulatory agencies.
· Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Strategic Plans, labeling documents, etc.
STRATEGIC AND EXECUTION
· Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
· With general 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.
· Creates, 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 execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
· Reviews and approves the promotional and non-promotional materials.
· Monitors 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 inform/advise in the regulatory decision making.
· Ensures/supports regulatory product compliance (e.g. IMR, PMCs, pediatric and other agency commitments).
· Manages the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed.
· Advises Global teams on local regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives
· As part of the Global Regulatory Team (GRT), provides regulatory direction/expertise on local regulatory mechanisms to…