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Vice President of Regulatory & Clinical Affairs

Blaine and Associates, Inc. Manhattan Beach, CA
  • Posted: 16 days ago
  • $200,000 to $275,000 Annually (plus commission)
  • Full-Time
  • Benefits: Vision, Medical, Life Insurance, 401k, Dental

VP of Clinical and Regulatory Affairs needed for rapidly growing biologic company. You will be responsible for taking a product through the entire BLA process, working with the FDA, and conducting Phase III trials.

You will supervise a team and be responsible for:

  • Developing strategies for the regulatory approval of existing and new biologic products
  • Oversee quality processes for company as it works towards a GMP facility designation
  • Prepare and submit pre-market clearance IND applications to the FDA
  • Maintain and manage biologic registrations, compliance inspections, remediation, field actions, MDR, and vigilance reporting processes
  • Develop, direct, and review product labeling for biologic registrations, sales and promotional purposes
  • Develop and maintain client's quality manuals, procedures, and systems
  • Represent company in management of FDA, GMP, and ISO quality system requirements
  • Supervise all personnel in Quality Control, Regulatory, and Clinical Affairs
  • Set long term goals as related to SOP and QSR
  • Responsible for clinical trial strategies to support IND within the US, Canada, and EU markets
  • Thorough knowledge of IRB review and approval process
  • Train, monitor and oversee clinical trial supervisors and ensure all trial obligations are met
  • Hire and oversee consultants and CROs
  • Write final study reports and other materials for clinical trials

PhD or other advanced degree required, 10+ years in similar role, experience in human tissue, stem cell or closely related field. Experience with Amgen, Gilead, Merck or Abbvie is ideal. We will pay more than our competitors to get the right executives to make our company soar!

Blaine and Associates, Inc.

Why Work Here?

This is an awesome opportunity to be around some of the best cars made and work on Saturdays only unless you want more days.

Blaine and Associates, Inc. is a boutique search firm specializing in Management, Accounting, Real Estate, Human Resources, Marketing, Administrative and Legal positions.

Address

El Segundo
Manhattan Beach, CA
USA

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