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Parexel · 4 hours ago

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

United States

Full-time

Remote

Senior Level

6+ years exp

Parexel is seeking a Regulatory Affairs Consultant - Global Labeling Lead for a temporary role dedicated to a large client partnership. The role involves driving labeling development and strategy, ensuring compliance with global regulations, and leading cross-functional teams to maintain accurate and effective product labeling.

Pharmaceuticals

H1B Sponsor Likely

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

Qualification

Labeling regulatory requirementsCCDS writing experienceRegulatory Information Management SystemElectronic document management systemProject managementEffective communication skillsAttention to detailStrategic thinkingTeam collaboration

Required

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

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

Preferred

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

Company

Parexel

Glassdoor3.9

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees

http://www.parexel.com

H1B Sponsorship

Parexel has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (33)

2024 (46)

2023 (41)

2022 (51)

2021 (54)

2020 (33)