Senior Manager Regulatory Affairs - CMC

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.

Sr Manager Regulatory Affairs

Live

What you will do

Lets do this. Lets change the world. In this vital role you will manage an external service provider and internal staff members within the Regulatory Optimization of Tactical and Strategic Support (ROOTS2) team. ROOTS2 is a team within the Global CMC Regulatory Affairs department responsible for execution of CMC submissions across countries, using standardized procedures to maximize efficiency. ROOTS2 works with teams in CMC and Device Regulatory, GRAAS, local country offices, and Operations in managing the execution of submissions (including CTAs, MAAs, Variations, Renewals, Site Registrations, and RTQs) from inception to dispatch.

• Oversight of an external service provider including, but not limited to, direct interactions with the vendor, management of contract and budget, oversight of resources and ways of working
• Supervising assigned team members with respect to management, training, and resource planning
• Support of CMC filings including Investigational New Drug (IND)/Clinical Trial Applications (CTAs), Marketing Application/Authorization, post-approval supplement/variations, renewals and responses to agency request for information across countries
• Collaboration with leadership across CMC Regulatory functions and other stakeholders
• Leading process improvements and documenting CMC Regulatory processes
• Providing expertise and guidance to interdepartmental and cross-functional teams
• Coaching and supporting junior staffs career development

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Regulatory CMC, Compliance, Lab, and/or Quality experience OR
• Masters degree and 6 years of Regulatory CMC, Compliance, Lab, and/or Quality experience OR
• Bachelors degree and 8 years of Regulatory CMC, Compliance, Lab, and/or Quality experience
• Associates degree and 10 years of Regulatory CMC, Compliance, Lab and/or Quality experience
• CMC specific regulatory knowledge and an understanding of manufacturing, process development, quality control, or quality assurance related to biologics, small molecules, biosimilars, and/or combination products
• Preparation of global CMC submissions across all phases of development
• In-depth knowledge of global CMC requirements, including country specific documents for submissions
• Experience managing and leading regulatory strategies for submissions including but not limited to IND/CTAs, Marketing Application/Authorization, Annual Reports, post approval supplements/variations, etc.
• Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
• Ability to work in a fast-paced environment while retaining a high attention to detail and quality
• Strong interpersonal, collaborative, problem solving and conflict resolution skills
• Ability to develop solutions to technical and organizational issues to improve performance and productivity

Preferred Qualifications:

• Degree in life sciences, biochemistry, or chemistry
• Experience in leading Global regulatory CMC submissions and an understanding of global requirements and ICH guidance
• Experience with manufacturing, process development, quality control, or quality assurance
• Experience with training and/or managing staff

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

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 requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.