Regulatory Affairs Manager - CMC

Amgen Inc.; United States; Remote; USD 113,000 - 153,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision

Disability insurance

Flexible spending accounts

Bonus program

Stock incentives

Generous PTO

Flexible work model

Job summary

Amgen, based in the United States, seeks a Regulatory Affairs Manager - CMC to lead site-specific regulatory strategies for post-market filings and registrations. You will coordinate with site functions to prepare regulatory filings, identify issues, and assess impacts on strategy with input from the CMC Product teams and regional representatives.

The role requires advanced degrees and substantial regulatory CMC experience; responsibilities include defining filing requirements, developing

Qualifications

• Doctorate degree
• Master’s degree with 2 years of Regulatory Affairs experience
• Bachelor’s degree with 4 years of Regulatory Affairs experience
• Associate’s degree with 8 years of Regulatory Affairs experience
• High school diploma / GED with 10 years of Regulatory Affairs experience

Responsibilities

• Define minimum regulatory filing requirements for post approval programs
• Provide regulatory strategy through development of MASP and/or GIRS
• Development of post approval variations
• Maintenance of applications (Annual Reports, Distribution Reports, Annual Stability updates)
• Maintain product compliance through appropriate regulatory filings and activities including regulatory commitments
• Provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative
• Support Change Management activities as needed
• Respond to regulatory agency questions
• Facilitate agency interactions, including meeting preparation, meetings and briefing documents
• Liaise with other Functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution and plans
• Contribute to the PDT’s Variation Master Plan as required
• Participate as an active member of cross-functional teams

Skills

Regulatory affairs knowledge

CMC regulatory experience

Cross-functional collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

CTD structure knowledge

ICH guidelines knowledge

Job description

Career Category

Regulatory 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.

Regulatory Affairs Manager - CMC

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for the strategy and execution of the site-specific aspects of the preparation of CMC post-market supplements and facility registrations. You will interface with site functions to coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity and provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative.

You will serve as Regulatory CMC voice for product teams by providing the following services:

• Define minimum regulatory filing requirements for post approval programs
• Provide regulatory strategy through development of MASP and/or GIRS
• Development of post approval variations
• Maintenance of applications (Annual Reports, Distribution Reports, Annual Stability updates)
• Maintain product compliance through appropriate regulatory filings and activities including regulatory commitments
• Provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative
• Support Change Management activities as needed
• Respond to regulatory agency questions
• Facilitate agency interactions, including meeting preparation, meetings and briefing documents
• Liaise with other Functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution and plans
• Contribute to the PDT’s Variation Master Plan as required
• Participate as an active member of cross-functional teams

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
• Master’s degree and 2 years of Regulatory Affairs experience
• OR
• Bachelor’s degree and 4 years of Regulatory Affairs experience
• OR
• Associate’s degree and 8 years of Regulatory Affairs experience
• OR
• High school diploma / GED and 10 years of Regulatory Affairs experience

Preferred Qualifications

• Degree in a life sciences discipline, or equivalent relevant experience.
• Experience in Regulatory CMC within the pharmaceutical or biotechnology industry.
• Working knowledge of ICH guidelines and current GMP and GCP requirements.
• Experience preparing and compiling regulatory dossiers in accordance with ICH guidelines and Common Technical Document (CTD) structure.
• Experience in pharmaceutical or biotechnology manufacturing, Quality Control (QC), or Quality Assurance (QA).

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, 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.

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.

Inclusive environment

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.

Equal Opportunity

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.

Salary Range

112,744.00USD -152,536.00 USD