Description

The Senior Director, Regulatory Affairs will report to the Vice President, Regulatory & Compliance and is responsible for leading, developing and executing the global regulatory strategy for Pliant’s oncology programs. This involves oversight for regulatory activities across the product lifecycle, from development through post-approval, while overseeing department activities and representing Regulatory Affairs in cross-functional teams. This highly visible and hands-on role will provide both strategic and operational support to regulatory activities across multiple therapeutic areas. This person will also lead interactions with the FDA and other regulatory agencies.

The Senior Director, Regulatory Affairs, must have strong strategic regulatory experience in oncology and be able to provide sound guidance, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. In addition, the Senior Director, Regulatory Affairs, will support an environment in which the team is highly motivated and engaged to work collaboratively within their team as well as cross functionally to deliver exceptional results and ensure long-term success.

(Remote* = Must be in our S.SF office 1X/mo.  However, during onboarding period, you will be required to be onsite 2X/mo.)

Responsibilities

• 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.

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.

• BA/BS Degree required in a health/life sciences or related field. Advanced degree preferred.
• A minimum of 15 years in Regulatory Affairs, of which at least 8 years have been in oncology and at least 6 years of leadership experience managing a team.
• Direct and successful experience in Regulatory activities including IND/CTA, NDA/BLA/MAA, lifecycle management, and developing and implementing complex regulatory strategies.
• Proven experience leading interactions and negotiations with Health Authorities (US and ex-US preferred).
• Strong understanding of relevant US FDA regulations as well as international regulatory agencies (e.g. EU/EMA).
• Experience in the ability to deliver high quality regulatory submission documents.
• Strong strategic skills including demonstrated ability to make complex decisions and willingness to defend difficult positions.
• Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment.
• Demonstrated excellence in project management with a proven track record of effectively managing multiple projects / priorities simultaneously. Demonstrated excellence in project management with a proven track record of effectively managing multiple projects / priorities simultaneously.
• Exceptional written and oral communication skills.
• Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
• Managerial and personal development experience required.

How you work

• Dare to Succeed: Approach regulatory strategy with courage and creativity, challenging convention when it advances patient outcomes. Take ownership of ambitious goals and navigate early‑development ambiguity with resilience and sound judgment.
• Make an Impact: Operate with urgency and focus, prioritizing high‑value actions that drive programs forward. Elevate regulatory quality and efficiency by anticipating obstacles and building scalable, best‑in‑class processes.
• One Pliant: Collaborate seamlessly across functions, building trust and alignment with internal and external partners.

The annual base salary for this role is $270K – $300K. 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.

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