Manager, Regulatory Writing (Open to remote)
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
R-129561 Manager, Regulatory WritingLive
What you will do
Lets do this. Lets change the world. In this vital role you will support the regulatory product development needs of the Amgen Biosimilars Unit through detailed development and implementation of global regulatory strategies, submissions, and plans.Responsibilities:
- Support the biosimilars business unit with the authoring and preparation of global regulatory documents, including INDs, IMPDs, CTAs, BLAs, MAAs, responses to questions, and briefing documents.
- Draft clinical, nonclinical, and regulatory documents that conform to global regulatory requirements, Amgen and industry standards, and accepted templates. May also draft CMC regulatory content, as needed.
- Manage review and approval of regulatory documents; engage members of cross-functional teams to address and resolve issues in accordance with established timelines.
- Ensure the accuracy, adequacy, and consistency of documents.
- In collaboration with Regulatory leads, participate in the development of study timelines for regulatory documents.
- Prepare, coordinate, and manage the review and approval of documents by:
- supporting the operation of the integrated review process
- performing comment reconciliation to address and resolve issues
- editing and creating updated drafts for the next phase of review in accordance with the established timelines
- ensuring the quality of documents by critically reviewing for accuracy, adequacy, and consistency
- Assist with process development initiatives to meet internal needs.
- Maintain awareness of regulatory environment, and keep abreast of new regulatory requirements that affect work projects.
- Seek opportunities to continue developing writing skills.
- Collaborate with multidisciplinary teams across global regions.
- Represent Biosimilars Regulatory Affairs on committees, as requested
- Develop, improve, and implement document templates.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications.Basic Qualifications:
- Doctorate degree and 2 years of directly related experience OR
- Masters degree and 4 years of directly related experience OR
- Bachelors degree and 6 years of directly related experience OR
- Associates degree and 8 years of directly related experience Or
- High school diploma / GED and 10 years of directly related experience
- Knowledge and experience with time management and timeline development.
- Strong working knowledge of regulatory (FDA, EMA, PMDA, ICH) guidelines and ability to apply these guidelines to projects and submissions.
- Ability to collaborate effectively with colleagues working remotely.
- Attention to detail.
- Strong oral and written communication skills.
- Ability to understand and communicate scientific information effectively with colleagues from a variety of disciplines, including clinical, nonclinical, and quality subject matter experts.
- Ability to discern areas of potential concern and communicate concerns effectively to manager.
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Join UsIf 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.Amgen requires all staff in the United States and Puerto Rico 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.