Regulatory Affairs Manager - CMC

Amgen Inc.; Thousand Oaks (CA); Híbrido; USD 113.000 - 153.000; Tempo integral

Benefícios oferecidos por esta vaga

Comprehensive benefits package

Bonus program

Stock-based incentives

Time-off plans

Flexible work models

Resumo da vaga

Amgen is seeking a Regulatory Affairs Manager - CMC to lead strategy and execution for site-specific CMC post-market filings and facility registrations. You will coordinate regulatory filings, identify issues impacting regulatory strategy, and provide impact assessments with cross-functional input.

The role requires advanced regulatory expertise (CMC, ICH, GMP/GCP) and experience preparing CTD-style dossiers, with opportunities to interact with global agencies and cross-functional teams.

Qualificações

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

Responsabilidades

• Define minimum regulatory filing requirements for post-approval programs.
• Develop regulatory strategy through MASP and/or GIRS.
• Develop post-approval variations and maintain applications.
• Ensure product compliance through regulatory filings and activities.

Conhecimentos

Regulatory strategy

ICH guidelines

CMC knowledge

Regulatory submissions

Formação

Doctorate or Master’s with 2+ yrs Regulatory Affairs

Bachelor’s with 4 yrs Regulatory Affairs

Associate’s with 8 yrs Regulatory Affairs

High school diploma with 10 yrs Regulatory Affairs

Descrição da vaga

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
• Bachelor’s degree and 4 years of Regulatory Affairs experience
• Associate’s degree and 8 years of Regulatory Affairs experience
• 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

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.

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 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.

Equal Opportunity

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. 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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen