Director of Regulatory Affairs

Company: GPAC
Location: Daly City
Posted on: May 24, 2023

Job Description:

A pharma company is looking to hire a Director of Regulatory Affairs.-- This role will develop and implement regulatory strategies for all phases of 505(b)(2) NDA and ANDA product development, from product pipeline evaluation to post-approval commercial production. The company has a high-quality product portfolio and is a successful multi-national business specializing in controlled-release pharma products.The company is growing and this role will be key to their success.

• Base Salary bonus and potential for stock options
• Ability to work remotely
• Strong culture and empowering environment with a team that has incredible tenure
• Focus on significant unmet patient needs, and high-barrier-to-entry generic drugsDirector of Regulatory Affairs Responsibilities:
  • Function as liaison with health authorities, including providing complete and timely responses to health authority requests for information, and representing company in Pre-IND, Pre-NDA, and other FDA meetings
  • Develop and implement integrated regulatory plans that deliver against strategic objectives, and maintain compliance
  • Ensure receipt of timely and actionable health authority feedback around key issues and program milestones, by defining the strategy and content to support agency interactions
  • Manage internal review/approval process for CMC related submissions and regulatory questions;
  • Prepare and submit FDA submissions (i.e. 505(b)(2) NDA, ANDA, pre-submissions,, PAS, annual report, CBE-0, CBE-30)Director of Regulatory Affairs Requirements:
    • Bachelors degree in life sciences, chemistry or related discipline, advanced degree preferred
    • 5-10 years of experience, including hands-on regulatory affairs and successful 505(b)(2) NDA and ANDA submission experience
    • Oncology experience strongly preferred
    • Experience with FDA/US regulatory submissions
    • Demonstrated excellence in regulatory liaison/strategy
    • Strong written and verbal communication skills
    • Able to work independently and in a team setting
    • Able to travel for meetings with corporate partners and regulatory authoritiesFor additional information on this opportunity, contact Miki Miller directly at 605.215.5248.-- You can email me directly at: All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations. GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

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