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Regulatory Affairs Manager

Newbury Park, CA
“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations tstaff augmentation external workers whqualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship tthis company, its operations, or its staff.”

Top 3 Must Have Skill Sets:            
  • CMC- regulatory knowledge & experience in small molecule (synthetics/ chemical) products, specifically regulatory affairs CMC knowledge related tsolid dosage form products (immediate and modified release)
  • CMC – regulatory knowledge in CMC amendments tclinical trial applications (IMPD/ IND)
  • Understanding and application of principles, regulatory guidance, and concepts, theories and standards of scientific/technical fields regarding solid dosage products

Day Day Responsibilities:        
  • Position is within Global Regulatory Affairs CMC organization.
  • Responsible for the strategy, preparation and execution of commercial and clinical CMC post-approval supplements, and registrations of small molecule (synthetics/chemical) products. Specifically, management and preparation of Module 2 and Module 3 sections for clinical trials and marketing application supplements/ variations intended for US, Europe, China and Japan.
  • Coordinate and manage product-specific tasks within the regulatory information system per the CMC Global product leads.
  • Interfaces with Global Regulatory Affairs, Regulatory Operations, International Regulatory CMC and other Global Reg CMC functions tcoordinate the preparation of regulatory submissions, and in the identification of issues, risks and factors that may implicate a regulatory strategy or activity.
  • Serve as Regulatory CMC liaison for the small molecule product team by providing the following services:
  • Assess minimum regulatory CMC requirements for post-approval programs for the following countries US, EU, China, Japan
  • Provide regulatory strategy through development of Module 3 strategic plans and regulatory strategy
  • Coordinate, develop and prepare CMC post-approval variations/ clinical CMC amendments
  • Maintenance of applications (Annual Reports, Annual Stability updates)
  • Maintain product compliance through appropriate regulatory filings and activities including regulatory commitments
  • Support Change Management activities, as needed
  • Support/lead responses tregulatory agency questions, as needed
  • Facilitate agency interactions, including meeting preparation, meetings, response trackers and briefing documents
  • Liaise with development, operations, and commercial teams tensure alignment of global regulatory strategies, timing, execution/preparation of Module 3 CMC components and plans
  • Participate as an active member of cross-functional teams

Education & Experience (Basic)

Doctorate degree and 2+ years of directly related experience
Master’s degree and 3 years of directly related experience
Bachelor’s degree and 5 years of directly related experience

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

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