San Diego, CA 92121
Manager, Regulatory Affairs
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.
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.
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
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
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.