Regulatory Affairs Director Global CMC

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Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Regulatory Affairs Director Global CMC

What you will do

Lets do this. Lets change the world. In this vital role you will f.

Responsibilities

• Oversees the development and execution of strategy by the CMC and Device Regulatory Affairs team for Obesity and Obesity Related Conditions (ORCs), ensuring strategic alignment across programs and geographies
• Represents the CMC and Device Regulatory Affairs Obesity team with Amgen leadership, governance bodies, regulatory agencies, and external partners
• Oversees and is accountable for all aspects of CMC and Device Regulatory strategies, decisions, and implementation plans for the Obesity portfolio
• Provides timely input to functional leadership for topics under review with Amgen executive leadership, review committees and other cross-functional product meetings
• Builds strong relationships with key external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally
• Provides strategic vision to guide the development of new department and cross-functional processes including technology and compliance initiatives
• Coordinates strategy, risk management and staffing requirements with team leaders across CMC and Device Regulatory Affairs functions
• Ensures alignment on priorities and strategies with the GRAAS Obesity TA, Operations and other teams as needed.
• Prioritizes projects to meet Corporate, Operations and R&D priorities
• Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation
• Provides leadership and direction to facilitate issue resolution and appropriate prioritization or resources to achieve goals for CMC and Device Regulatory Affairs staff working on Obesity assets
• Provides coaching, mentoring, and supports development of CMC and Device Regulatory Affairs staff working on Obesity assets
• Assists in the recruitment of talented GRAAS and Amgen staff and supports retention of regulatory professionals
• Develops CMC and Device Regulatory Affairs goals in alignment with department goals

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

Or

Masters degree and 7 years of regulatory experience

Or

Bachelors degree and 9 years of regulatory experience

Preferred Qualifications:

• Substantial experience leading CMC Regulatory Affairs strategy and execution for biologic products in differing stages of the product lifecycle
• Experience of leading and/or participating in meetings with regulators in major markets (US, EU, Japan and China)
• In-depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for biologics
• Track record of shaping the external regulatory environment through external engagement with regulators and other stakeholders

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, well 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.

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.

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.

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