Director Regulatory Labeling (Contract)
About The Position
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care. POSITION SUMMARY: The Director, Regulatory Affairs – Labeling will provide strategic and operational leadership for the global product labeling function. This individual will be responsible for shaping and implementing regulatory labeling strategies across the product lifecycle, from development through post-approval activities, while ensuring compliance with applicable regulatory expectations and evolving global standards. This individual will work closely with colleagues across product development, clinical development, medical, market access, and commercial functions to develop Target Product Profiles and draft labeling appropriate to each stage of development and product lifecycle. This person will bring experience working with health authorities on labeling matters, including successful negotiations, as well as a strong background supporting global regulatory activities. This is a contract/temporary role.
Requirements
- Bachelor’s degree in life sciences, computer science, or another related scientific discipline.
- At least 8 years of experience within the biotechnology or pharmaceutical industry with responsibility for developing and/or maintaining product labeling globally
- Familiarity with advertising and promotional regulations, FDA guidance, and relevant aspects of drug development and product labeling.
- Demonstrated experience leading cross-functional meetings and guiding strategic discussions, including negotiations with internal stakeholders and regulatory authorities on complex labeling matters.
- Proven ability to assess regulatory labeling documents for accuracy, consistency, and compliance with applicable requirements and to identify discrepancies or areas of nonconformance.
- Strong working knowledge of document preparation and formatting, including Microsoft Word, PDF compliance, and document validation tools.
Responsibilities
- Partner with cross-functional teams to establish and advance regulatory labeling strategies and chair or lead cross-functional labeling discussions.
- Oversee the creation, review, approval, maintenance, and document control of global labeling materials, including Target Product Labeling, Core Labeling such as the Company Core Data Sheet (CCDS), and regional documents such as the U.S. Prescribing Information (USPI) and EU Summary of Product Characteristics (SmPC). Ensure activities are completed within required timelines and in accordance with internal procedures and external regulatory expectations.
- Serve as a subject matter resource on regulatory labeling requirements, maintaining current knowledge of applicable regulations and guidance and advising internal stakeholders on their appropriate interpretation and application.
- Evaluate labeling within relevant therapeutic areas, including competitor and comparable product labels, to inform the development of proposed labeling language and support contingency planning for discussions and negotiations with regulatory agencies.
- Perform proofreading and quality control activities for labeling deliverables. Confirm that labeling content accurately reflects available data, meets applicable regulatory standards, and remains aligned and consistent across related labeling documents.
- Coordinate with internal partners and subject matter experts to gather input on labeling content, address significant regulatory questions, and resolve issues associated with proposed labeling revisions.
- Work in partnership with Clinical Regulatory and other cross-functional teams to support labeling supplements, labeling modifications, and interactions with health authorities involving product labeling.
- Ensure that finalized and approved labeling documents, along with relevant supporting materials, are appropriately distributed to applicable stakeholders.
- Maintain controlled documentation and records associated with labeling revisions and communicate implemented changes to relevant internal audiences.
- Develop strong working relationships across functions and contribute regulatory labeling expertise in support of broader strategic and business objectives.
- Contribute to initiatives designed to improve and strengthen the full labeling lifecycle and associated end-to-end processes.
- Track changes within the global regulatory landscape and evaluate the potential implications for the organization and its product labeling activities.
- Support the development and revision of internal policies in collaboration with relevant stakeholders.
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What This Job Offers
Job Type
Full-time
Career Level
Director
