Description

Pliant is seeking an accomplished, creative, and dedicated regulatory professional to contribute to the Company’s mission of helping patients with life-threatening fibrotic diseases. The position will report to a Director of Regulatory Affairs and will support the regulatory activities for Pliant’s development programs. This includes supporting the strategic and operational activities for molecules from pre-clinical to clinical all the way to marketing applications.

Responsibilities

• Lead activities in support of development and submission of regulatory dossiers as required to support global clinical trials, including initial INDs/IND amendments, CTA’s, IMPDs, annual reports, etc.
• Regulatory representative on internal clinical study teams and external CRO, review of clinical trial documents (protocols, ICF, investigator package).
• Support Regulatory Authority interactions and the preparations of meeting request and briefing document content.
• Support the strategy development, preparation and submission of global regulatory applications e.g. ODDs, PIPs.
• Participate in study and development teams and provide regulatory guidance as needed.
• Establish, manage, and maintain knowledge of current and emerging regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to cross-functional teams.
• Assure compliance with regulatory standards and guidance documents.
• Conduct regulatory risk assessments on issues that arise in development teams.
• Lead or support the generation or revision of SOPs related to regulatory affairs.
• Work with external regulatory consultants/CRO’s as required.
• Create Regulatory topic presentations and conduct educational activities for wider Pliant team members.

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 5 years of years in regulatory affairs in pharmaceutical industry.
• Experience and knowledge in preparation of initial INDs/CTA/IMPD and amendments ,health authority interactions and managing responses to health authority questions.
• Working knowledge of FDA, EMA and ICH regulatory guidance and regulations.
• Experience in working in small dynamic pre-commercial stage company is desirable.
• Strong collaboration and cross-functional team participation skills.
• Demonstrated ability to prioritize and manage multiple tasks while delivering on respective timelines for each project.
• Ability to interact effectively across all levels of 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 oral and written communication skills, strong interpersonal skills, and detail oriented.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $160,000 - $170,000. 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.