Position

Regulatory Director

Pharmaceutical & Medical Device

 

Full-time
Work Remotely

DESCRIPTION

  • Regulatory representation and leadership to cross-functional product development teams, development of regulatory strategies and support for clinical and non-clinical development programs and marketing applications. 

  • Responsible for project timelines and management of 510K, PMA, IND, NDA and global regulatory submissions. 

  • Lead regulatory activities including planning and reviewing of CMC, clinical and nonclinical sections of regulatory submissions. 

  • Plan, direct and prepare regulatory submissions (IND, NDA, IDE, 510(k), PMA) to ensure compliance with FDA and international regulations and guidelines. 

  • Develop and maintain SOPs with an emphasis on drug and device regulations. 

  • Perform research regarding regulatory strategic recommendations, and new and revised governmental regulations. 

  • Conduct successful negotiations and interactions with domestic and foreign regulatory agencies on assigned projects. 

  • Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials. 

  • Prepare and assist with applicable regulatory audits. 

  • Statistical techniques.  


EDUCATION REQUIREMENTS:  

  • Minimum of B.S. in life sciences, engineering, or equivalent required. 

  • Advanced degree preferred. 

GettyImages-481489751.jpg

EXPERIENCE REQUIREMENTS: 

  • Minimum 5-7 years of experience in regulatory affairs for pharmaceutical and medical device biopharmaceutical companies. 

  • Experience with successful FDA and international agency negotiations and audits. 

  • Experience in developing and submitting successful 510(k), PMAIND/NDA submissions with a thorough understanding of the drug and device development processes, FDA regulations and ICH guidelines. 

  • Excellent verbal and written communication skills. 


OTHER QUALIFICATIONS: 

  • Detail oriented with well-developed organizational and analytical skills. 

  • Experience with submitting documents in CTD and eCTD format. 

  • Suited to working in a fast-paced, small company environment. 


We value innovation, scientific rigor, collaboration and a passion for change.