Collidion, Inc. and it’s subsidiaries, Plex Pharmaceuticals & Avenlogics, Inc.
Flexible. Companies are based out of Petaluma and San Diego, CA.
Pharmaceutical & Medical Device Regulatory Affairs Director
General Job Description:
Seeking a Regulatory Affairs Director to provide leadership in a number of areas, that includes regulatory filings and interacting with regulatory bodies in the US and abroad.
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 5 years of experience in regulatory affairs for pharmaceutical and medical device biopharmaceutical companies.
Veterinary product experience highly desirable.
Experience with successful FDA and international agency negotiations and audits.
Experience in developing and submitting successful 510(k), PMA, IND/NDA submissions with a thorough understanding of the drug and device development processes, FDA regulations and ICH guidelines.
Excellent verbal and written communication skills.
Application Information & Contact (How to Apply)
To apply, visit www.collidion.com/careers