United States Regulatory Lead, Senior Manager

Career Category

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.

Global Regulatory Policy and Intelligence Manager

What you will do

The United States Regulatory Lead (USRL), Sr. Manager is assigned to one or more Amgen products, and plans and executes the Regulatory strategies for that product(s) in the United States. The product(s) assigned have complex programs/strategies and high impact to Amgen. 

Strategic and Execution

• Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
• With minimal 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).
• 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.
• Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Strategic Plans, labeling documents, etc.
• 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)

COMMUNICATION AND COLLABORATION

• Works closely with cross-functional colleagues in the country to align on strategy and deliver country 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 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.

Scientific and Technical

• Knowledge of Regulatory principles.
• Working with policies, procedures, and SOP’s.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• Good knowledge of national legislation and regulations relating to medicinal products.
• Awareness of the registration procedures/challenges in the U.S. for CTAs, MAs, and all lifecycle management activities.
• Knowledge and experience in the local regulatory environment relevant for product area and development stage.
• Understanding of drug development.
• Able to anticipate regulatory Agency questions and potential response.

Basic Qualifications

• Doctorate degree and 2 years of related experience OR
• Master’s degree and 4 years of related experience OR
• Bachelor’s degree and 6 years of  related experience OR
• Associate’s degree and 10 years of related experience  OR
• High school diploma / GED and 12 years of related experience

Preferred Qualifications

• Doctorate or Master’s degree (scientific area) and 6 years of directly related experience OR
• Bachelor’s degree (scientific area) and 8 years of directly related experience
• In-depth regulatory experience in the U.S.
• In-depth knowledge of U.S. legislation and regulations relating to medicinal products.

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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 sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.

Salary Range