US Regulatory Lead

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 optimize product development (eg, expediting studies, Orphan Drug Designations, expedited regulatory designations, compassionate use, and pediatric plans)

HEALTH AUTHORITY INTERACTIONS

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

· Participates/contributes to local agency interactions and their preparation.

COMMUNICATION AND COLLABORATION

· Works closely with cross-functional colleagues in the country, Affiliate or Hub to align on strategy and deliver country/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 International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) 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 create relationships with Agency staff on specific product assignment (if applicable).

· Establishes regular contacts and interactions with Distributors (if applicable).

· Provide SME support to process improvement projects / initiatives.

COUNTRY SPECIFIC ACTIVITIES

· Assists locally in Healthcare Compliance activities where applicable.

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

· Oversees external vendor/contractor relationships where applicable.

· Assists locally in Healthcare Compliance, QA or pharmacovigilance activities where applicable.

REGULATORY RESEARCH

· Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products

· Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement

MENTORING

· Mentors and/or advises other(s) Local Regulatory Representatives at more junior levels.

What we expect of you

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

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 3 years of US Regulatory experience

OR

Bachelor’s degree and 5 years of US Regulatory experience

OR

Associate’s degree and 10 years of US Regulatory experience

OR

High school diploma / GED and 12 years US Regulatory

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• •Understanding of drug development.
• •Knowledge of Regulatory principles.
• •Regulatory submissions experience and experience interacting with regulatory agencies (FDA)
• •Working knowledge of U.S. legislation/regulations relating to medicinal products and applicable regulatory principles
• •Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• •Knowledge and experience in the US regulatory environment relevant for product area and development stage.

• •Demonstrate strong teamwork ability.
• •Good communication skills - both oral and written.
• •Good negotiation and Influencing skills.
• •Ability to understand and communicate scientific/clinical information.
• •Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
• •Working with policies, procedures, and SOP’s.
• •Cultural awareness and sensitivity to achieve results across both regional, country and international borders.

What you can expect from 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.

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