Pliant Therapeutics

Compliance

• Lead the development and implementation of regulatory oncology strategies that result in successful registration and post-approval commercialization of products and product-candidates.
• Provide guidance to the cross functional teams based on technical and regulatory knowledge towards the development and implementation of strategic and tactical plans in alignment with corporate objectives.
• Proactively identify and assess regulatory risks associated with product development for Pliant’s oncology program.
• Serve as the regulatory agency contact (e.g. FDA and other agencies) and in this capacity, fosters strong agency relationships while acting as a credible, reputable, and effective advocate for the company.
• Effectively lead meetings with Health Authorities to ensure full resolution of issues and opportunities.
• Lead all interactions/submissions to global Health Authorities including initial IND/CTAs, NDA/MAAs, supplements and variations, and any other key areas of discussions.
• Ensure the regulatory strategy is aligned with global Health Authority requirements and review documents for submission readiness to ensure that all submissions conform to relevant guidelines.
• Ensure that content in regulatory applications is complete, well-written, and meets all relevant requirements for the program’s development phase.
• Support the product team in managing and directing regulatory inspections.
• Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
• Facilitate the strategies for the approval of products in rest-of-world regions either by the company or by its partners/affiliates, and act as the regulatory contact for ongoing alliance management activities.
• Partner with and support clinical development, CMC, medical affairs, commercial and corporate activities, including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle.
• Support the Pharmacovigilance and Safety functions as an active member of the Safety Governance and Review team.
• Lead, manage, and develop a high performing team to support organizational growth as a late-stage clinical organization, including providing professional and personal growth opportunities, mentorship, and change management.
• Provide the business development team with guidance and critical evaluation of potential product opportunities, in support of strategic partnering and licensing activities.
• Support long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.
• Help manage the external regulatory vendor and service team members and providers.
• Manage internal regulatory procedures to ensure compliance.

Senior Director, Regulatory Affairs – Oncology Strategy