logo

View all jobs

Sr Associate Regulatory Affairs – CMC

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers 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 this company, its operations, or its staff.”
                                                            
Top 3 Must Have Skills
  • Must have direct and RECENT CMC experience. Experience with assessments in change control. (RA CMC, Manufacturing, Quality Control, etc.). (looking for CMC within last 1 or 2 years. NOT 10 years ago)
  • Must be able to work independently and multi-task in a fast paced environment.
  • Experience working on biologics and small molecules, commercial and clinical is highly desired.
Other soft skills
• Can-do Attitude – Ideal candidate does not easily give up. The candidate will be provided direction and support but will need to be methodical and analytical when completing tasks while exhibiting a positive attitude (Amgen is a very large organization and there will be many parties the candidate will need to engage with for project success).
• Being Comfortable With Being Uncomfortable – Ideal candidate will not only be able to identify problems but also identifies possible solutions. Project end goals will be known but all the in-between steps may not be known from the start so the candidate will need to navigate and structure the steps without being easily flustered.
• Attention to Detail – Ideal candidate will be thorough and deliver polished work product.
D

Daily Responsibilities
Daily responsibilities will be focused on providing submission execution support to products across modalities, regions and phases of development
  • Assessing change controls for reportability
  • Fulfilling country specific document requests
  • Supporting manufacturing and quality with regulatory feedback
  • Supporting facility registration submissions
Daily Responsibilities
Daily responsibilities will be focused on providing submission execution support to products across modalities, regions and phases of development

"This posting is for Contingent Worker, not an FTE"
 

More Openings

IT Project Manager
Associate

Share This Job

Powered by