jobs

Director of Regulatory Affairs

Pneuma Respiratory
Boone, NC Full-time
Posted on August 25, 2019

Position will be responsible for development and implementation of regulatory strategy as well as regulatory oversight of company projects. This person will interact with outside regulatory agencies and trade associations and act as advisor to senior management in regard to planning, evaluation, and recommending regulatory strategy. He/she will be responsible for all regulatory agency relations including preparation, submission, and follow-up interactions with any/all agencies, including the FDA. Bachelor's degree and experience with aerosol delivery and 505(b)(2) required. Salary and benefits package commensurate with experience.

 Top Reasons to Work for Us

  1. Competitive Salary
  2. Company pays 100% of health insurance
  3. Stock option grants
  4. Work from home
  5. Help build life changing technology

Must Have Skills:

  • Experience preparing 505 (b)(2) submissions
  • Successful track record of 505(b)(2) submissions for devices containing software components
  • Ability to work across organizational levels, able to effectively negotiate and influence, results focused.
  • Excellent verbal and written communication skills, ability to partner with others,
  • Proven cross-functional leadership skills, ability to prioritize and adapt to change in a startup environment.
  • Self-motivated creative problem solver and can deal with ambiguity and declare a path forward to achieve results.
  • Strong computer skills, with proficiency in word processing, spreadsheet and presentation software.

 Responsibilities

  • Ensure regulatory submissions meet appropriate standards and content requirements.
  • Lead and manage regulatory annual updates and submissions.
  • Manage and track regulatory authorities’ questions. Working with cross-functional teams to provide responses to the questions on time. Manage and track regulatory responses and commitments.
  • Work effectively in cross-functional teams and support the team objectives in delivering project milestones.
  • Ensure timely submission of regulatory submissions
  • Support the development of regulatory strategies to enable accelerated product development timeline
  • Establish SOPs and workflows and find creative ways to resolve problems.

 Minimum Qualifications

  • B.S. with 8+ years or Ph.D with 5+ years’ experience in regulatory affairs for pharmaceutical company
  • Prior experience with drug IND/NDA/ANDA/sNDA/BLA preferred
  • Prior experience with aerosol delivery and 505(b)(2) pathway strongly preferred
  • Experience in regulatory strategies and submissions for clinical stage programs
  • Proficient in FDA and international regulations and requirements
  • Knowledge in GLP, GMP and GCP regulations
  • Willing to contribute and add value to company’s bottom line
  • Travel (up to 10%) may be required, including international travel