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Senior Director, Regulatory

Senior Director, Regulatory

Job Title: Senior Director, Regulatory
Contract Type: Permanent
Location: San Francisco, California
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: HQ00REG
Contact Name: Ben Richardson
Contact Email: b.richardson@sciproglobal.com
Job Published: January 12, 2017 13:27

Job Description

The Regulatory Affairs Professional (Director) will be responsible for the comprehensive management of regulatory aspects of the company's development projects while actively contributing as a member of the project team(s). This position will also require key contributions to department and company initiatives related to regulatory affairs operations and strategy.

Duties and Responsibilities

  • Responsible for working with the project team to identify an optimum regulatory strategy for assigned projects. Able to lead teams in examining regulatory strategy options.
  • Expected to independently interact with regulatory authorities, and outside consultants when needed. Able to independently prepare and lead a team through a regulatory meeting exercise.
  • Able to write, review and edit regulatory documentation, ensuring it is fit for purpose, and to serve as a resource for regulatory document authors regarding the appropriate content of submissions.
  • Supervises and provides guidance to other regulatory personnel as assigned.

Qualifications

  • Education: Minimum Bachelor's degree; studies in science and advanced degree desirable
  • Specialized knowledge that would be desirable and supportive of success in this position includes:
    • Experience working on promotional materials and with OPDP (formerly DDMAC).
    • Experience with US and international management of post-marketing CMC changes
    • Experience in pediatric drug development and understanding of US and EU regulations related to pediatric requirements
    • Experience in the management of core labeling and/or US labeling
    • Understanding of regulatory requirements for and experience with submission of applications (IND / NDA) in eCTD format
    • Ability to create and manage detailed timelines and/or experience with tracking regulatory activities across disciplines and territories
    • Experience in other key functional areas, (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics) appreciated
  • Experience: Minimum 10+ years progressive Regulatory Affairs or relevant experience