Regulatory Writing, Manager

Thousand Oaks, CA, US
Nov 02, 2020
Required Education
Bachelors Degree
Position Type
Full time
The purpose of this group is to support the regulatory product development needs of the Amgen Biosimilars Business Unit through detailed development and implementation of global regulatory strategies, submissions, and plans.

• 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 scientific, clinical, nonclinical, CMC, and regulatory documents that conform to global regulatory requirements, Amgen and industry standards, and accepted templates.
• Manage review and approval 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.

• Participate in the development of study timelines for regulatory documents.
• Prepare, coordinate, and manage the review and approval of documents by:

o supporting the operation of the integrated review process

o performing comment reconciliation to address and resolve issues

o editing and creating updated drafts for the next phase of review in accordance with the established timelines

o 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.
• Seek opportunities to continue developing writing skills.
• Keep abreast of regulatory requirements that affect work projects.
• Collaborate with multidisciplinary teams across global regions.
• Represent Biosimilars Regulatory Affairs on committees, as requested

• Develop, improve, and implement document templates.

• Contribute to the continuous improvement of internal processes and initiatives.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment, and inclusion in all that we do.

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.

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.