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Regulatory Affairs Senior Associate

Thousand Oaks, CA
Description:
Note:

Remote
  • The ideal candidate for this role is an entry-level professional with strong communication skills, adept at understanding and conveying scientific information, and comfortable with ambiguity.
  • They should have a bachelor’s degree with at least two years of experience or a master’s degree, preferably in a science or engineering field.
  • Familiarity with Office 365 is essential, and while experience in FDA-regulated or biotech/pharma industries is preferred, candidates from other regulated sectors will also be considered if they have relevant education.
  • This position is primarily administrative, focusing on documentation coordination under managerial oversight.

Description:
  • In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
  • To coordinate and execution of US regulatory submissions with the US Regulatory Lead in compliance with corporate standards and local regulatory requirements.
  • To manage and execute of the preparation, delivery and electronic archiving of documentation for inclusion in US regulatory submissions
  • To assist the Global Regulatory Lead to manage GRT interactions

The responsibilities of the Regulatory Affairs Senior Associate position are:
  • Assist US Regulatory Lead to support regional regulatory activities (e.g. IND submissions and agency meetings)
  • Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with Regional Regulatory Lead
  • Create and maintain product regulatory history documents through Amgen systems and appropriately archive all regulatory documents and agency communications
  • Review regional component of the Global Regulatory Plan and provide input to operational deliverables
  • Collaborate with CRO’s / partners to support site initiation
  • Coordinate collection of functional documents in support of regulatory filings
  • Participate in GRT to support execution of regulatory strategy
  • Coordinate QC of regulatory documentation (e.g. briefing materials)
  • Provide primary authorship to routine regulatory correspondence (e.g. annual reports,
  • investigator packages)
  • Prepare regulatory packages and cross-reference letters to support investigator initiated studies
  • Complete regulatory forms to support agency communications
  • Provide regulatory support through cross-functional interactions in work package teams (eg. commercial and evidence generation teams)
  • Support process improvement initiatives, standards development, and metrics
  • Assist in template development and maintenance
  • Respond to specific requests from and communicate relevant issues to GRT
  • Develop Regulatory Position with GRT
  • Actively support regulatory compliance
  • Support the development and execution of GRT goals

Basic Qualifications    
  • Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Top 3 Must Have Skill Sets:        
  • Strong communication skills - both oral and written
  • Ability to understand and communicate scientific/clinical information
  • Ability to deal with ambiguity

Pay Rate- between $35 - $40/Hr on W2 based on experience.

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

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