Manager/Senior Manager, Regulatory Affairs

6/4/21

Kansas City, KS 66101

1259

FullTimeRegular

Manager/Senior Manager, Regulatory Affairs

The Manager/Senior Manager, Regulatory Affairs is responsible for assisting with worldwide regulatory requirements for all pipeline and commercial products and reports to the Director of Regulatory Affairs.

Additionally, the role is responsible for the:

  • Development and implementation of comprehensive regulatory strategies and tactics (pre- and post-approval), meeting worldwide regulatory requirements including, but not limited to INDs, NDAs 505(b)(1), NDAs 505(b)(2), ANDAs, DMFs, MAA, etc.
  • Regulatory Lead for assigned product(s)
  • Preparation, review, revision, and finalization of appropriate scientific and regulatory documents associated with pre-approval pipeline and commercial products in compliance with all appropriate regulations and guidelines.
  • Direct interaction and liaison with regulatory agencies as required.
  • Develop collaborative and respectful relationships with internal and external customers, ensuring activities are performed according to regulatory strategies and assisting with regulatory questions.
  • Regulatory review, assessment, and approval of change controls.

EDUCATION AND EXPERIENCE

  • Degree in scientific discipline, advanced degree preferred.
  • Minimum of 5 years regulatory affairs experience with extensive knowledge and experience of US regulatory affairs.
  • Direct relevant experience with complete drug product development programs receiving regulatory approval and launched commercially.
  • Direct relevant experience with dry powder and liquid formulations preferred.
  • Pharmacovigilance experience preferred.
  • Regulatory review of advertising/promotional materials preferred.

PERSONAL CHARACTERISTICS

  • Strong attention to detail and deadlines
  • Problem solving skills
  • Ability to multi-task
  • Strong interpersonal skills and an effective communicator (phone, email, web-ex, video, in person)
  • The successful candidate will be able to work effectively in a high-energy, environment and adaptive to emerging issues

Apply Now