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Manager/Sr. Manager, RegCMC

May 7, 2019

  

 

 

 

Company Name:

Pacific-Link Consulting

 

Job Location:

Remote-San Diego Area

 

Position Title: 

Manager/Sr. Manager, RegCMC

 

Position Type:

Full Time

 

General Job Description:

 

Pacific-Link Consulting, a San Diego based, full-service Regulatory Affairs consulting company, is seeking a full-time Regulatory Affairs professional with an expertise in CMC who will be responsible for planning and authoring high-quality CMC-related, as well as general regulatory submissions to the FDA in accordance with regulatory guidelines and applicable federal laws. If hired, the position will work remotely and report directly to the Sr. Director, Regulatory Affairs and Pharmacovigilance.

 

Responsibilities

  • Communicating regulatory CMC requirements for INDs/NDAs/NDSs/Amendments to team members, as well as clients.

  • Preparing and writing a variety of high-quality submissions (i.e., Module 3 summaries, CMC-related Amendments and Supplements, Annual Reports, Meeting Requests, Briefing Packages, etc.).

  • Critically reviewing documentation intended for submission to the FDA for internal consistency and compliance with FDA regulations and guidelines.

  • Participating in the establishment of submission timelines and ensuring that the due dates for submissions are met

     

Qualifications:

 

  • Minimum of 5 years experience in regulatory affairs.

  • Minimum of a Bachelor's Degree in a life or physical science.

  • Preferred - Regulatory Affairs certification or Master of Science (M.S.) in Regulatory Affairs

     

     

Application Information & Contact (How to Apply)

 

As an employee, you’ll enjoy our competitive compensation and benefits packages. We invite you to consider a career with Pacific-Link Consulting by submitting your resume to tracyr@pacificlinkconsulting.com.

 

Please reference job code RA and your name in the subject line in the email (Example: RA – John Smith).

Learn more about Pacific Link Consulting here

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