Regulatory Affairs Consultant - Global Labeling Lead (Temporary 12-18 mos))

Exciting temporary labeling strategist role dedicated to one large client partnership!

The Labeling Strategist will drive the labeling development and strategy, in-line with overall global strategy, and by providing labeling expertise for Company Core Data Sheet (CCDS) and local labeling (USPI, SmPC and other), from early-stage development through to product maintenance. Facilitates strategic development of labeling and labeling components by leading a diverse cross-functional labeling subteam through discussion and decisions. Evaluates and communicates strategies and anticipates risks associated with labeling content, timelines, labeling compliance and implementation.

Responsibilities

• Demonstrate high-level understanding of labeling content requirements, regulations, and guidance in support of labeling strategies worldwide, including key scientific, clinical, medical, and key messages and differentiation strategies.

• Leads or contributes to cross functional teams across the organization, to drive and align the development and maintenance of global labeling (e.g. CCDS, regional product labels, and patient labeling) for assigned compounds.

• Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global strategy and key messaging.

• Evaluate and communicate risks associated with CCDS content updates and implementation strategies.

• Drive labeling for package labeling (mockups/artwork) development, update, and maintenance through collaboration with a cross-functional team.

• Support global HA interaction strategy regarding all aspects of labeling, including submissions, responses to questions, and negotiations.

• Demonstrate understanding of current labeling content requirements, regulations, and guidance to ensure all assigned compound labeling documents are accurate, consistent, and compliant.

• Assess competitor labeling in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling

• Manage and maintain labeling documents in document management systems; Manage label review and approval.

• Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc.).

• Support inspection readiness activities related to all global labeling components.

• Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.

• Collaborate with global colleagues, affiliates and Alliance partners, as needed.

• Develop clear communications for senior management and labeling stakeholders, to streamline and facilitate label development, negotiations, and approval.

• During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies.

• Support global HA interaction strategy to discuss key labeling elements

• Lead response to Health Authority (HA) questions for labeling. Respond to labeling related inquiries from global Health Authorities in an efficient manner to meet required timelines.

• Analyze and interpret new regulations and Guidance, as well as monitor and determine impact on product labeling.

Qualifications

Education and Experience

• BSc or advanced scientific degree (MSc, PhD or PharmD) preferred.

• 6-8 years of relevant pharmaceutical Labeling/Regulatory experience.

• Thorough understanding of scientific principals and regulatory systems, relevant to drug development

• Experience writing CCDS and local labeling documents for new products

Knowledge and Skills

• Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required

• Solid understanding of implications of global labeling across the organization and globally

• Solid understanding of the structure of product labeling

• Experience in effectively/appropriately prioritizing and managing multiple high to medium complex projects simultaneously

• Ability to work independently or in teams, globally. Ability to lead broad range of stakeholders at all levels internally and externally to the company.

• Effective written and oral communication and organizational skills

• Strong attention to detail

• Solid aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS); Proficiency in MS Office suite; Willing to learn additional applications

• Ability to think strategically, communicate risks, and recommend innovative solutions to problem solving

• Ability to recognize and escalate issues

• The ideal candidate should be action-oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, and be comfortable working with multifunctional teams.

Candidates located within the EST in the US or Canada are highly preferred due to the client's locations.

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.