Pharmaceutical & Medical Device
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.
Minimum of B.S. in life sciences, engineering, or equivalent required.
Advanced degree preferred.
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.
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.