Sr Associate Regulatory Affairs AFP

Location: Thousand Oaks, CA
Date Posted: 09-05-2017
Day to Day Responsibilities:     
Ability to quickly learn the regulatory documentation system, regulatory support to USRL in FDA submission preparation, drafting cover letter, archiving info in system, and regulatory research/intelligence gathering.

Normal working hours M-F onsite ONLY Thousand Oaks. More of an entry level role - so Ideal candidate would be someone from USC regulatory Science MS/DO program or similar USC Science program. Will also look at candidates with multiple years of experience Regulatory US Role, Global Regulatory US labeling within Biopharmaceutical industry.

The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.

Key Activities:
• Assist Regional Regulatory Lead to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations)
• Provide and maintain CTA/MA documentation support (e.g. annual reports, amendments) in collaboration with Regional Regulatory Lead
• Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications
• Review regional component of the Global Regulatory Plan and provide input to operational deliverables
• Ensure compliance with submissions to regulatory agencies
• Support RRL in review of promotional materials for commercial activities (ex-US)
• Collaborate with CRO’s / partners to support site initiation
• Coordinate collection of functional documents in support of regulatory applications
• As appropriate participate in GRT to support execution of regulatory strategy
• Coordinate QC of regulatory documentation (e.g. briefing packages)
• 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
• Approve drug shipment for Amgen and Investigator Initiated Studies
• Complete regulatory forms to support agency communications (E.G. Eudract, FDA form 1571)
• Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area 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 teams
• Actively support regulatory compliance
• Support the development and execution of GRT goals

Knowledge and Skills:
Strong communication skills - oral and written
Organizational skills

Education & Experience (Basic):
Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum,
Bachelor’s degree in a science discipline (biology, life science, health science) and 2 years of directly related experience

Education & Experience (Preferred):
Regulated industry, science or clinical practice experience

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