Director/Senior Director, Regulatory Affairs CMC
Provides leadership for all regulatory aspects of Chemistry, Manufacturing and Controls (CMC) and assures optimal functioning of internal and external interfaces between Regulatory CMC and stakeholders for activities across all product development projects. Closely interacts with multiple functions to create high quality regulatory submissions that support product development strategy. Reports to Senior Vice President Regulatory and Quality Assurance. Open to remote candidates.
- Proactively manages regulatory CMC aspects of programs including overseeing preparation and submission of CMC submissions supporting clinical trial applications and marketing applications appropriate to phase of development.
- Ensures timely delivery of high quality CMC documents including, regulatory authority requests for information, meeting briefing books, meeting minutes, IND/IMPD/CTA submissions, NDA /MAA submissions, and DMFs while assuring all documents meet regulatory requirements and quality compliance.
- Supports and complies with procedures established by Regulatory Operations function responsible for electronic submissions and document archiving to ensure efficiency and traceability of all CMC regulatory documents.
- Facilitates the development of, reviews and comments on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data and information appropriate to phase of development.
- Articulates complex Regulatory CMC issues to project teams and external stakeholders to support global development and commercialization of drug candidates.
- Evaluates proposed manufacturing and quality changes for impact to ongoing and existing filings, and provides strategic regulatory guidance for optimal implementation of changes.
- Manages interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, amendments/supplements/variations, and other submissions which present CMC information.
- Develops and maintains excellent relationships with regulatory authorities, internal functional groups, contract manufacturing organizations, and corporate partners.
- Support Quality Assurance in preparing and hosting regulatory inspections.
- Facilitates the development of regulatory desk procedures; reviews SOPs issued by the Quality Assurance group related to area of responsibility.
- Maintains current understanding of the laws, regulations and guidelines pertaining to CMC/Quality information relevant to Cidara’s development programs and antimicrobial agents
- Supports SVP in the development of overall product development and registration strategy.
- Collaborates with SVP to identify resource needs, including consultants and new associates advising on skills sets to meet needs.
- Supports SVP in other areas of development (clinical and nonclinical) as required.
- BS in a scientific discipline, a combination of relevant education and applicable job experience may be considered.
- 10+ years in Regulatory Affairs CMC plus recognized technical expert.
- Demonstrated ability to deliver high quality regulatory documents.
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements, guidelines, and market and policy trends.
- Experience with antimicrobial drugs developed using aseptic processing and or fermentation/cell culture; experience with products formulated for multiple routes of administration and for adult or pediatric use; experience with drug delivery using devices (desirable)
- Extensive regulatory experience across value chain including IND/CTA/IMPD, NDA/BLA/MAA, lifecycle management, interactions with Regulatory Authorities, developing and implementing complex CMC regulatory strategies with a proven track record of significant regulatory accomplishments.
- Prior success filing IND/CTA/IMPD and NDA/BLA/MAA within timelines is required; global submission experience required.
- Familiar with publishing requirements for electronic regulatory submissions for US, including use of ESG, as well as international electronic submissions, as applicable.
- Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities.
- 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.
- Advanced Degree
- Experience with nonsterile GMP manufacturing
- Experience in CMC/Quality aspects for development of investigational products with Fast Track designation, Qualified Infectious Disease designation (desirable), or other expedited regulatory development pathways; experience with Orphan Drug development (desirable)
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