The Everest Group


*A division of The Everest Search Group, Inc., Los
  Angeles, CA
*The Everest Search Group Inc., Lake Tahoe, NV

Ranked Top 200 of America's Best Executive Search Firms in 2017 by Forbes

Manager Regulatory Affairs Operations


COMPANY
Our client is located in the Los Angeles area near Santa Monica and is a growing biopharmaceutical company with a market capitalization of over $2B and stock that has increased over 500% in the last year. This client is dedicated to cancer research and development, with multiple on-going clinical trials in late stage development including two in Phase III that have hit all end points, a strong pipeline, and a large cash reserve this client is poised to be the next “IT” Biotechnology company.

RESPONSIBILITIES
• Manage assigned projects and closely collaborate with personnel from Regulatory Affairs and other scientific departments (as with CROs), to coordinate and implement high quality submission output.
• Develop and manage day-to-day submission plans through the use of project management and planning tools, to create and maintain a detailed multi-functional project timelines.
• Work to ensure electronic assembly of all submissions are planned, coordinated, and delivered on time, and adhere to company and agency standards. Utilize current electronic document management and publishing tools to publish dossiers according to regulatory requirements for paper and electronic submissions.
• Identify appropriate resources/business strategies needed to support submission publishing activities. Maintain the submission-tracking process in support of short and long-term submission and resource planning.
• Be accountable for the management of submission projects, including the preplanning, tracking, assembly, submission, and archiving of regulatory documents.
• Provides operational direction to senior management, ensuring that company practices are in conformance with the latest health authority and industry submission standards.
• Initiate, author and/or collaborate on Standard Operating Procedures, Work Instructions, and Work Flows for the Regulatory Operations function.
• Maintain electronic systems necessary to carry-out functional activities (i.e. eCTD publishing tool, Electronic Submission Gateway).
• Interact and/or negotiate with the FDA and other regulatory agency in interpreting and implementing electronic standards related to eCTD and other submission formats. Source, manage and disseminate Regulatory Guidance pertinent to submission standard cross-functionally.

QUALIFICATIONS
• Bachelor’s degree in a scientific discipline or systems technology or equivalent.
• 5 to 7 years experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health)
• Advanced working knowledge of eCTD publishing systems, EDMS technology, lSI Toolbox and related publishing tools.
• Extensive knowledge of North American/Global submission standards (FDA, Health Canada, EMA, ICH, GXP, eCTD, etc.), and industry trends for dossier preparation (i.e. IND/CTA/NDA/MAA/NDS).
• Experience in project management and a clear understanding of US and ex-US requirements with regard to submission content and format. 
• Computer proficiency in Microsoft Office, including: Word, Excel, PowerPoint, Project, and Documentum technology.
• Advanced knowledge of pharmaceutical development (CMC, Nonclinical, Clinical research), with the ability to understand and interpret data/information and its practical application.

COMPENSATION
Base $80,000 - $110,000+
Bonus target 10-12%
Generous stock options allotment & stock options yearly
Fully paid benefits
Lump sum relocation