• Support the development of CMC regulatory strategies in collaboration with regulatory and CMC SMEs to meet business objectives for all Pliant’s development projects, registration, NDA-readiness, and commercial launch
• Coordinate the authoring and timely submission of regulatory dossiers as required to support global clinical trial applications, including initial INDs/IND amendments, IMPDs, annual reports, requests for information, etc.
• Support interactions with global regulatory authorities to ensure acceptance of CMC information in support of regulatory submissions and applications, including leading the authoring of CMC content in briefing documents.
• Work with Regulatory-CMC and CMC teams to ensure that CMC content in regulatory applications is complete, well-written, and meets all relevant requirements
• Evaluate proposed manufacturing changes for global impact to ongoing and existing applications and provides strategic regulatory guidance for optimal implementation of changes
• Participate on project teams and provide expertise on CMC regulatory matters.
• 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 and inter-facing Quality workstreams.
• Work with external regulatory consultants/CRO’s as required.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.

• Bachelor’s degree in a scientific discipline required, advanced degree preferred
• Minimum of 10 years’ experience with 4-8 years in regulatory affairs CMC experience with global clinical phase submissions and health authority interactions
• 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
• Deep knowledge of FDA, EMA and ICH regulatory guidelines and regulations
• Small company / pre-commercial stage company experience desirable
• Excellent 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 details

The annual base salary for this role is $208K – $219K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.