Clinical Regulatory Affairs Manager - 22-125
Fully Remote
Description

 Work as a Regulatory member of clinical study and related teams to provide regulatory guidance for successful execution of clinical studies and regulatory submissions. Partner and work collaboratively with cross-functional teams. This is a remote-based position. 

  • Represent Regulatory Affairs on internal teams for clinical studies and coordinate regulatory documentation for submissions to Health Authorities.
  • Prepare routine US IND submissions an CTAs for outside US
  • Manage and communicate regulatory guidelines for execution of clinical studies and submissions
  • Assist in development of regulatory strategies – collect, create, and organize necessary documents and data effectively
  • Review and evaluate content from regulatory perspective to assure completeness and accuracy
  • Foster constructive working relationships when interacting with colleagues
  • Communicate strategic input of regulatory affairs to clinical teams for alignment among relevant functional departments and key stakeholders.
  • Participate in routine and ad hoc departmental meetings and other meetings to maintain awareness of the company business needs and the evolving regulatory environments/trends.
  • Understand and be able apply comprehensive understandings of clinical regulations and guidelines (FDA, ICH) for improvements of regulatory success and compliance
Requirements
  • BS/BA Degree in a Scientific Discipline, biotechnology associated discipline preferred
  • 5-8 years’ experience in pharma industry; or advanced degree with 3 years pharma experience
  • In-depth knowledge of national and regional regulatory legislation and guidelines
  • Experience in oncology a plus
  • Ability to work independently as well in a matrixed, team environment
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems
  • Good time management; able to manage competing priorities
  • Advanced skills in MS Word, MS Excel, MS PowerPoint, and Adobe Acrobat are essential
  • Must be flexible, detail-oriented, and possess excellent analytical and problem-solving skills.