Associate Director/Director, Regulatory Affairs CMC
Pliant is seeking a passionate, creative and dedicated regulatory CMC professional to contribute to the Company’s mission of helping patients with life-threatening fibrotic diseases. The position will report to the Head of Regulatory Affairs and will lead the regulatory CMC strategy for Pliant’s development programs. This includes strategic and operational leadership of global regulatory CMC activities for molecules in the pre-clinical to clinical stage.
- Independently develop CMC regulatory strategies to meet business objectives for Pliant’s development projects
- Lead the authoring, review, and timely submission of regulatory dossiers as required to support global clinical trials, including initial INDs/IND amendments, IMPDs, annual reports, requests for information, etc.
- Lead Regulatory Authority interactions with regards to CMC
- Participate on project teams and provide expertise on CMC regulatory matters.
- Establish, manage, and maintain a knowledge of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to CMC and RA colleagues
- Ensure product labeling is in compliance with regulatory requirements in all regions
- Assure compliance with regulatory standards and guidance documents
- Conduct regulatory risk assessments on issues that arise in development teams
- May lead or support the generation or revision of SOPs related to regulatory affairs.
- Work with external regulatory consultants/CRO’s as required.
- Bachelor’s degree in a scientific discipline required, advanced degree preferred
- Minimum of 7 years of related pharmaceutical or biopharmaceutical industry experience including at least 2 years in regulatory affairs supporting CMC submissions
- Small molecule development or manufacturing experience required, biological experience preferred
- Experience and knowledge in preparation of initial INDs/IMPD and amendments
- Experience in health authority interactions and addressing health authority questions
- Working knowledge of FDA, EMA and ICH regulatory guidances and regulations
- Small company / pre-commercial stage company experience desirable
- Strong collaboration and cross-functional team participation skills
- Ability to prioritize and manage multiple tasks while delivering on respective timelines for each
- Confidence in interacting with varying levels of internal management and external regulatory authorities
- Preference for applying a solutions-oriented mindset and approach to resolving complex regulatory issues
- High self-awareness and commitment to iterative learning and development
- Effective communicator, verbal and written, strong interpersonal and influencing skills
- Accuracy and attention to detail
- Ability to operate in alignment with Pliant’s values