SDRAN Address

MAILING ADDRESS
SDRAN
P.O. Box 927595
San Diego, CA 92192-7595

 

Contact us

Join us on:

 

  • LinkedIn Social Icon

© 2016 SDRAN 

Manager, Regulatory Affairs

February 12, 2020

  

 

 

 

 

 

 

Company Name:

Cidara Therapeutics

 

Job Location:

San Diego, CA 92121

 

Position Title: 

Manager, Regulatory Affairs

 

Position Type:

Full time

 

General Job Description:

 

The Manager, Regulatory Affairs will contribute to the Regulatory Affairs department in the maintenance of global Phase 3 clinical trials and NDA registration. The RA manager will represent Regulatory Affairs on cross- functional project teams and provide regulatory support and guidance regarding overall regulatory strategy to ensure high quality submissions in compliance with global regulations and guidelines. The RA manger will be responsible for reviewing the content of regulatory submissions (INDs, CTAs, NDA/MAA), briefing books, clinical protocols and nonclinical reports. Reports to the Senior Director, Regulatory Affairs.  

 

Position Summary:

 

The Director of Regulatory Affairs is responsible for developing practical regulatory plans and strategies for therapeutic products, communicating with regulatory agencies, ensuring timely preparation, review, and submission of documents to regulatory agencies, and maintaining compliance with applicable regulatory requirements to achieve corporate goals effectively.

 

 

Responsibilities:

 

  • Prepare and maintain global regulatory submissions

  • Critically review contents of clinical, nonclinical or CMC regulatory documents, protocols and reports

  • Independently execute regulatory strategies regarding submissions and/or compliance issues

  • Coordinate timely planning of routine regulatory submissions with the Regulatory Affairs Operations team

  • Represent Regulatory Affairs to cross-functional project teams and CROs as required at the study team level for management of CTAs

 

Qualifications:

 

  • Bachelor's in scientific discipline or equivalent, combination of relevant education and applicable job experience may be considered

  • 6-8 years of relevant experience in regulatory affairs with drug or biologic products

  • Experience with global regulatory submissions

  • Strong scientific background and experience in critical review and interpretation of scientific/clinical data

  • Ability to manage conflicting priorities and meeting tight timelines

  • Experience in interacting with FDA or EU competent authorities

  • Demonstrated ability to manage a complex workload and prioritize tasks based on program goals.

  • Strong verbal and written communications skills, as well as problem-solving skills

  • Ability to work quickly and independently and as a strong team player

 

Preferred Qualifications

 

  • Advanced degree such as Masters in Regulatory Sciences or other scientific disciplines will be preferred

  • RAC certification will be a plus

  • Experience in infectious disease area is desirable but not required

 

 

 

Application Information & Contact (How to Apply)

 

Please apply to our company website using the following URL

Learn more about Cidara here.

Tags:

Please reload