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Job Announcement: Pharmaceutical and Medical Device Regulatory Affairs Director

April 26, 2018

 

 

Company Name:

Collidion, Inc. and it’s subsidiaries, Plex Pharmaceuticals & Avenlogics, Inc.

 

Job Location:

Flexible. Companies are based out of Petaluma and San Diego, CA.

 

Position Title: 

Pharmaceutical & Medical Device Regulatory Affairs Director

 

Position Type:

Full-time 

 

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.

 

Responsibilities:

  • 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.

 

Qualifications:

  • Bachelor’s degree in a scientific discipline with 5 years of job related experience. 

  • Advanced degree preferred.

Experience Requirements:

  • 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

 

 

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