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Pliant Therapeutics · 1 month ago

Senior Director, Regulatory Affairs – Oncology Strategy

South San Francisco, CA

Full-time

Onsite

Director/Executive

$270K/yr - $300K/yr

15+ years exp

Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and commercialization of therapeutics for fibrotic lung diseases. The Senior Director of Regulatory Affairs will lead the global regulatory strategy for oncology programs, overseeing regulatory activities and interactions with health authorities while ensuring successful product registration and compliance.

BiotechnologyHealth CareHealth DiagnosticsPharmaceuticalRecruitingTherapeutics

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

Qualification

Regulatory AffairsOncology ExperienceFDA InteractionsRegulatory Strategy DevelopmentRegulatory SubmissionsProject ManagementTeam LeadershipCommunication SkillsInterpersonal SkillsDecision Making

Required

BA/BS Degree required in a health/life sciences or related field

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

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