Ardelyx® is building an integrated biopharmaceutical company with a gastrointestinal and cardio-renal focus. Our mission is to serve patients through the discovery, development and commercialization of minimally-systemic therapeutics that target intestinal receptors and transporters to address unmet medical needs.
Reporting to the Director of Regulatory Affairs, this position will be responsible for contributing to proactively managing CMC aspects of one of more global clinical programs including overseeing preparation and submission of global CMC submissions, ensuring the CMC content is complete, well-written and meets all relevant requirements. This position will contribute to the evaluation of proposed manufacturing changes for regulatory impact to ongoing and existing filings and providing strategic regulatory guidance for optimal implementation of changes. In this role, research and interpreting global CMC regulations will be required and providing regulatory guidance to the various cross functional areas such as Quality, Manufacturing, Process Development and other functional groups. This role will represent the RA CMC function on assigned cross-functional project teams developing excellent relationships with all cross functional teams, contract manufacturing organizations and corporate partners.
- Contribute to the development of stage-specific CMC regulatory content, including marketing applications for US, Europe and selected global markets, with an eye towards sound product lifecycle principles.
- Provide CMC regulatory guidance, both internally and externally (CMOs), regarding CMC changes such as analytical changes, specification changes and manufacturing changes plus their impact on regulatory filings.
- Charter and manage submission teams through all stages of submission execution, leading to delivery of high-quality, on-time CMC Regulatory submissions. Ensure adequacy of required CMC documentation for regulatory submissions (IND, CTA, NDA and MAA) for U.S. and international applications
- Work with CMOs to ensure accuracy of CMC information provided to regulatory authorities as prepare for pre-approval inspections (PAI).
- Participate in meetings with other functional groups on CMC regulatory issues
- Maintain awareness of and expertise in FDA and ICH guidelines related to CMC regulatory topics. Provide interpretation and communication of CMC Regulatory Intelligence as appropriate with guidance
- Write, review, and qc CMC sections of regulatory submissions as needed.
- Write, review and qc CMC responses to questions from regulatory agencies with guidance.
- Provide RA review of change control assessments.
- Keep abreast of regulatory knowledge and initiatives including ICH, USP, EP, FDA and other Health Authorities as well as other regulatory intelligence sources
- Other duties as assigned
- Foster a collaborative environment and contribute to a positive, dynamic, high-energy organization
- Bachelor’s Degree or/and graduate level with scientific background
- 5+ years in regulatory affairs in the pharmaceutical industry
- Experience in FDA CMC submissions utilizing eCTD format and electronic submissions
- Strong CMC background. Must have strong analytical skills and ability to communicate across all levels of the organization
- Strong oral and written communication skills as well as strong organizational skills
- Ability to interpret and understand regulatory and cGMP requirements and apply to Regulatory submissions and job duties
- Proficient in Microsoft Suite of products, experience with VEEVA RIM preferred.
- Ability to manage timelines in a project team environment
- 15% Travel to attend Health Authority meetings, domestic training seminars and possibly meet with CMOs
As a member of the Ardelyx team, you will help develop therapeutics that are designed to act in the gastrointestinal tract with minimal systemic exposure. Our drug candidates target important diseases and conditions. We are developing novel therapeutic agents that address unmet medical needs, with a gastrointestinal and cardio-renal focus.
We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world class research. Ardelyx offers a competitive total rewards package, perks and an innovative and dynamic culture.
Ardelyx, Inc. is an Equal Opportunity Employer.