Senior Director/Executive Director, Regulatory Affairs
Provides leadership for regulatory aspects of clinical and nonclinical development. Closely interacts across functions, proactively provides regulatory strategy and high-quality submissions that support product development goals. Reports to the Senior Vice President Regulatory Affairs and Quality Assurance.
- Develop and implement regulatory strategies to advance products through development, and ultimately, secure approval.
- Address complex issues by providing regulatory solutions and guidance to the cross-functional teams and senior management.
- Articulate complex regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates.
- Author, review, and/or edit regulatory documents and presentations, as necessary.
- Manage coordination, preparation, and timely submission of regulatory documents including INDs, NDAs, etc. while assuring all documents meet regulatory requirements and quality compliance.
- Manage interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, review and approval of clinical trial applications, marketing applications, amendments/supplements/variations.
- Develop and maintain excellent relationships with regulatory authorities, internal functional groups, contract manufacturing organizations, and corporate partners.
- Act as the company point of contact for Health Authority interactions.
- Monitor global regulatory changes relevant to Cidara’s development programs and antimicrobial agents.
- Support and contribute to the continuous improvement of existing department processes.
- Collaborate with SVP to identify resource needs, including consultants and new associates.
- BS or BA in a scientific discipline, a combination of relevant education and applicable job experience may be considered.
- 15+ years in Regulatory Affairs with a proven track record of significant regulatory accomplishments.
- Knowledge and experience in interpretation of regulations, guidelines, and precedents related to drug development in the US and EU.
- Demonstrated ability to provide strategic guidance and high-quality regulatory documents to support development.
- Familiar with publishing requirements for electronic regulatory submissions for US.
- Excellent written and oral communication skills with ability to positively impact and influence peers and team.
- Highly resourceful team-player, with the ability to be extremely effective independently.
- Strong negotiating skills: able to think creatively, develop creative solutions and effectively communicate solutions to stakeholders.
- PC literacy required - proficient use of technology including MSOffice skills (Outlook, Word, Excel, PowerPoint, document management systems, and Internet resources is expected).
- Ability to travel up to 10% as required.
- Experience in antimicrobial therapeutics.
- Advanced degree.
- Regulatory Affairs Certification through RAPS.
- Advertising and promotion and/or labeling experience.
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