Director, Regulatory Affairs

Employer
Bachem
Location
Torrance, CA
Posted
Nov 27, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Director or Regulatory Affairs manages the RA employees and oversees the day-to-day operations of the Regulatory Affairs department at both Bachem US sites (Vista & Torrance). The Director of Regulatory Affairs is responsible for the regulatory filing strategy for US FDA and other regulatory agencies. This individual will oversee the planning and execution of major submissions and responses to regulatory authorities related to Drug Mater File submissions, Annual Reports, as well as responses to requests from these agencies. The incumbent oversees and participates in the preparation of submissions of drug master file (DMF) for API to US/Global health authorities. The RA Director will also provide technical data packages to customers for preparation of their own submissions.

MINIMUM QUALIFICATIONS

Required:

  • Bachelor’s Degree in a Science related field - Chemistry, Biology or equivalent
  • Solid Chemistry background
  • Minimum of 8 years of experience in a regulatory affairs function including regulatory submissions, corresponding and interacting with regulatory agencies, particularly FDA
  • At least 5 years of experience in people management and leadership
  • Experience with the preparation of Chemistry, Manufacturing and Control sections for regulatory submissions
  • Experience with compiling and submitting drug master file for bulk drug substance
  • Ability to interact well with customers, co-workers and regulatory authorities
  • Ability to function well in a team environment
  • Strong organizational skills
  • Excellent written and oral communication skills
  • Proficient computer knowledge, including Microsoft Word, Excel, PowerPoint and Access
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Ability to work independently and manage one’s time

Preferred:

  • Master’s Degree in a Science related field or Regulatory Affairs
  • Regulatory affairs Certification through the Regulatory Affairs Professional Society
  • Technical writing experience

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

  • Hire, manage, and develop teams to support Regulatory Affairs activities at two locations
  • Manage continued growth, development, and retention of the team
  • Directly manage a team of regulatory affairs project managers and specialists at Bachem Americas
  • Establish Priorities and set goals for the Regulatory Affairs function
  • Ensures the regulatory affairs department is properly trained as well as coach and mentor direct reports
  • Develop strategies for DMF filing with FDA and other regulatory agencies
  • Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs
  • Provide regulatory leadership and guidance to project teams
  • Oversee multiple projects involving drug master files submissions, amendments, annual reports, and any related correspondence and letters of authorization for two locations
  • Compile and submit drug master files for active pharmaceutical ingredients
  • Develop response strategies and submissions to regulators’ requests
  • Contact regulatory agencies relevant to assigned projects or programs, as appropriate
  • Prepare annual reports for regulatory submissions
  • Develop and maintain a schedule of periodic updates for all regulatory submissions. Ensure   updates are filed within timelines
  • Maintain records of regulatory submissions, associated letters of authorization and technical data packages
  • Maintain records of all correspondence with regulatory agencies and customers related to regulatory submissions
  • Compile technical data packages for active pharmaceutical ingredients and other substances for use by customers in the preparation of their own submissions