Regulatory Affairs Manager - Oncology and Regulatory Promotion

BioSpace; Washington (District of Columbia); Sur place; USD 140 000 - 210 000; Plein temps

Avantages offerts par ce poste

Retirement and Savings Plan

Medical, dental, and vision coverage

Life and disability insurance

Stock-based long-term incentives

Discretionary annual bonus program

Generous paid time off

Résumé du poste

Amgen is seeking a Regulatory Affairs Manager in Oncology and Regulatory Promotion to lead strategic positioning for approved and pipeline oncology products. You will ensure truthful, non-misleading communications and regulatory compliance with FDA guidance, while mentoring reviewers.

Join a collaborative, science-driven team focused on delivering safe, effective therapies to patients, with opportunities to influence product strategy and cross-functional collaboration across the US organization.

Qualifications

• Doctorate or equivalent with regulatory experience.
• Regulatory promotion and labeling knowledge.
• Experience interpreting FDA regulations and guidance.

Responsabilités

• Provide strategic direction for product communications in oncology and disease states.
• Serve as regulatory advertising and promotion lead for approved/pipeline oncology products.
• Ensure deliverables align with labeling and FDA regulations and Amgen SOPs.
• Identify opportunities/challenges affecting US product strategy.
• Evaluate evidence levels to support product claims
• Mentor manager-level promotional reviewers

Connaissances

Regulatory affairs

Oncology

Strategic thinking

Regulatory compliance

Leadership

Formation

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Description du poste

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 Manager - Oncology and Regulatory Promotion

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for formulating and communicating the regulatory promotional position for approved and/or pipeline Oncology products and disease state.

Responsibilities

• Provide strategic direction for product and disease communications and associated activities by interpreting current regulatory environment to ensure truthful and non-misleading communication to health care community, patients, and the public
• Serve as a regulatory advertising and promotion lead for approved and/or pipeline Oncology product and disease state
• Ensuring deliverables are consistent with the product label, compliant with US FDA regulations and guidance, and adhere to Amgen SOPs and policies
• Identifying opportunities and challenges that impact US product strategy based upon evolving competition, regulatory environment, and clinical data
• Experienced in evaluating appropriate levels of evidence to make product claims
• Mentor Manager level promotional reviewers

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
• Masters degree and 2 years of industry experience
• OR
• Bachelors degree and 4 years of industry experience
• OR
• Associates degree and 8 years of industry experience
• OR
• High school diploma / GED and 10 years of industry experience

Preferred Qualifications

• 2 years experience in Oncology
• Experience in interpretation of government regulations, policies, and guidance
• Strong clinical data analysis skills
• Ability to use judgement and data to formulate and communicate positions on complex issues
• Experience collaborating within large cross-functional teams

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, 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.

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

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.