Director – Regulatory Affairs Labeling

Description

Pliant is seeking a candidate to play a key role in providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of regulatory labeling strategy and documentation for all Pliant products. This position will partner with Regulatory Affairs, Medical Affairs, Legal, Clinical Development, and Commercial and will lead the Label Working Group. This role will report to the Senior Director of Regulatory Advertising and Promotion.

This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).

Responsibilities

• Lead the development, revision, review, approval, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)), and derived documents (labeling text for EU, US) for assigned compounds.
• Give strategic direction, sound recommendations and guidance about labeling content, processes, timelines, and scientific integrity. Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation. Ensure high quality and compliant labeling documents.
• Provide strategic guidance regarding new and revised labeling regulations, competitor labeling, and labeling trends.
• Exhibit a strong understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling.
• Coordinate project timelines, set milestones, and monitor progress to ensure labeling projects meet established deadlines.
• Support training initiatives by developing and delivering training materials related to labeling
• Prioritize the continuous improvement of the end-to-end labeling process.
• Demonstrate an understanding of broad concepts within regulatory affairs and implications across organization. Proactively identifies labeling issues and offers creative solutions and strategies, including risk mitigation strategies.
• Keeps up to date on emerging clinical, product safety, and post-marketing data that may trigger changes to the company core datasheet and labeling.
• Manage labeling negotiations and drafts responses to Health Authorities queries. Guides/supports all labeling related negotiation meetings or teleconferences, as needed.
• Proactively recognize and take ownership of new labeling assignments, assessing project requirements and aligning resources.
• Track and manage health authority labeling requests and responses.
• Lead the development of labeling policies, procedures and SOPs.

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.

• BS degree in scientific, clinical or related area required. Advanced degree highly desirable. Regulatory Affairs certification strongly preferred.
• 12 years pharmaceutical/biotechnology industry experience with a minimum of 8 years in Regulatory Affairs
• Proven track record of successful submissions to FDA and in-depth working knowledge of labeling.
• Excellent leadership skills with ability to lead and influence cross functional teams focused on attaining company goals.
• Ensure labeling is compliant with applicable regulations (e.g., FDA, EU MDR, ISO standards) and internal quality standards.
• Strong technical writing and documentation skills.
• Expertise in interpreting regulations, guidelines, policy statements, including comprehensive knowledge of applicable regulations with demonstrated knowledge relevant to labeling.
• Proven ability to foster effective, positive interactions with regulatory agencies and corporate partners and to effectively interface with the senior management team and regulatory agencies.
• Adaptability with small company lean-resourced mindset for effectively working with peers, which includes hands-on experience drafting regulatory documents and submissions with practical experience relevant to labeling.
• Well organized with exceptional communication skills, strong influencing skills, and a demonstrated ability to use constructive debate to identify and move others towards optimal outcomes.

The annual base salary for this role is $225K – $235K. 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.