Associate Director Regulatory Affairs

3 days ago


San Diego, California, United States BioSpace, Inc. Full time
Job Title: Associate Director Regulatory Affairs

At BioSpace, Inc., we are seeking an experienced Associate Director Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for establishing regulatory strategies and plans, communicating with internal stakeholders, and ensuring compliance with regulatory requirements.

Key Responsibilities:
  • Develop and implement regulatory strategies and plans to support product development and commercialization
  • Collaborate with cross-functional teams to ensure regulatory compliance and effective communication
  • Prepare and submit regulatory documents, including INDs, CTAs, NDAs/BLAs, and MAAs
  • Lead Regulatory Authority interactions and meetings to ensure successful outcomes
  • Manage and oversee regulatory activities, including clinical trials and operational aspects
  • Provide guidance and support to the regulatory team and other departments
Requirements:
  • Bachelor's degree in Life/Health Sciences; Master's degree and/or Ph.D. a plus
  • Minimum of 7 years of experience in pharmaceutical/biotech with a minimum of 4+ years in clinical Regulatory Affairs
  • Comprehensive knowledge of current US and ex-US regulations and guidelines
  • Experience leading Regulatory in Global environments, including development of strategies and assessment of risks
  • Strong project management skills and ability to establish strategy and translate it into an effective action plan
  • Demonstrated success in effectively leading cross-functional teams and fostering collaboration
What We Offer:
  • Competitive compensation and benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment


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