Global Regulatory Lead Obesity and Related Conditions

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Global Regulatory Lead - Obesity and Related Conditions

Live

What you will do

Lets do this! Lets change the world!

Amgen is seeking a Global Regulatory leader with expertise and execution for the development registration and lifecycle management of all Amgen molecules.

The Global Regulatory Leader (GRL) is a product facing role that leads the Global Regulatory Team in the Regulatory Affairs organization. The purpose of this role is:
To lead one or more Global Regulatory Teams within Amgens Global Regulatory Affairs department
To 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
To provide regulatory expertise and guidance to product teams (eg Product Team (PT) Evidence Generation Team (EGT) Global Safety Team (GST))

Win

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.

Key responsibilities

• Demonstrated ability to lead teams
• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Understanding of regulatory activities and how they affect projects and processes
• Ability to anticipate and mitigate against future strategic issues & uncertainties
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome influencing and negotiation skills
• Cultural awareness and sensitivity to achieve results across both regional country and International borders.
• Competencies:

Win

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 5 years of regulatory experience in biotech or science

OR

Masters degree and 8 years of regulatory experience in biotech or science

OR

Bachelors degree and 10 years of regulatory experience in biotech or science

Preferred Qualifications:

Preferred Qualifications:

• Contemporary obesity experience desired

• Demonstrated ability to lead regulatory aspects of highly complex programs in late development

• Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application

• 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 and 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

• Organizational savvy

• Negotiation skills

Thrive

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

Apply now and make a lasting impact with the Amgen team.

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.

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.

#Obesity

Salary Range