Title: Director, Global Regulatory Affairs, Autoimmune
Location: New York City or Edison, NJ
If you are interested in the below position, please send your resume to firstname.lastname@example.org and reference the position title within the subject line.
This person will be responsible for developing and implementing the global regulatory strategy for the multiple sclerosis program and future autoimmune programs, and will serve as a primary liaison to US FDA, EMA, and other key market health authorities. This person will work cross-functionally with clinical, manufacturing, commercial, and CROs on regulatory affairs related issues.
––Develop and implement the global regulatory strategy for the multiple sclerosis program and future autoimmune programs
––Serve as a primary liaison to US FDA, EMA, and other key market health authorities for the multiple sclerosis program and future autoimmune programs
––Work cross-functionally with clinical, manufacturing, commercial, and CROs on Regulatory Affairs related issues
––Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities, including but not limited to information requests, meeting requests, briefing packages, fast track applications, orphan drug applications, breakthrough therapy designation applications
––Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
––Manage the completion of documents and other assigned tasks within established timelines and with high quality
––Maintain awareness of developing views/guidance within FDA and EMEA on general and specific topics related to the therapeutic area and other development projects as appropriate
––Bachelors in scientific discipline
––A minimum of 10 years pharmaceutical industry experience in in clinical regulatory affairs, inclusive of at least 7 years’ experience in a senior regulatory leadership role formulating strategy and driving decision-making
––Advanced degree preferred.
––Completed Bachelor’s degree in a scientific discipline required. Advanced degree preferred.
––Preference for prior experience in Neurology or Autoimmune therapeutic areas.