Manager, Regulatory Affairs
The Manager, Regulatory Affairs will contribute to the Regulatory Affairs department in the initiation and maintenance of global Phase 3 clinical trials. 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. The RA manager will interact with contract vendors to provide documentation requested by them for global submissions. Reports to the Senior Director, Regulatory Affairs.
- 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
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.
Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company