Global Regulatory Affairs Director - Inflammation and Rare Disease

Job description

Job Title: Global Regulatory Affairs Director - Inflammation and Rare Disease

Job Location: Washington D.C., District of Columbia, United States

Job Location Type: Remote

Job Contract Type: Full time

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

What you will do

Let’s do this. Let’s change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Inflammation and Rare Disease Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.

In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Director is to lead GRTs within Amgen’s GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions, and to provide regulatory expertise and guidance to product teams.

Key Responsibilities:

Develop and execute the global regulatory product strategy

Lead GRTs

Represent Regulatory on the product team and other key commercialization governance bodies

Develop Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks

Represent GRA on the product team

Develop registration strategies and plans aimed at achieving regulatory approval and product labeling

Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent

Lead the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)

Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)

Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment

Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory strategy

Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood

Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)

Attend key regulatory agency meetings which could impact the global product strategy

Represent Amgen Regulatory on external partnership teams at the product level

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 and 4 years of regulatory experience in biotech or science

Or

Master’s degree and 7 years of regulatory experience in biotech or science

Or

Bachelor’s degree and 9 years of regulatory experience in biotech or science

Preferred Qualifications:

Ability to lead and build effective teams

Strong communication skills - both oral and written

Ability to understand and communicate scientific/clinical information

Ability to anticipate and mitigate against future strategic issues & uncertainties

Ability to resolve conflicts and develop a course of action

Cultural awareness and sensitivity to achieve global results

Planning and organizing abilities

Able to prioritize and manage multiple activities

Ability to make complex decisions and solve problems

Ability to deal with ambiguity

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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

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Worksite address

washington, DC, 20022, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.