New · posted Oct 19
Parexel · Pharmaceuticals
Senior / Global Regulatory Labeling Strategist
- Remote, US
- Remote
- Full-time
- Senior & Principal
Open until filled
The role
Technical Expertise
- Must be familiar with and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise).
- Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS.
In this role, you will provide strategic leadership and operational oversight for global labeling activities, including hands-on ownership of Target Product Label (TPL) development for early-stage assets, Company Core Data Sheets (CCDS), regional labeling strategies, health authority responses, and labeling support for major regulatory applications. You will also contribute to medical and technical writing activities, ROW impact assessments, and cross-functional decision-making that influences product development and commercialization globally.
As a key member of the regulatory team, you will define labeling strategy, lead governance committees, partner with global stakeholders across Regulatory, Clinical, Safety, Medical, and Commercial functions, and ensure the delivery of compliant, high-quality labeling documentation throughout the product lifecycle.
What you need
Education
- Bachelor’s degree in Life Sciences or related field; advanced degree (MSc, PhD, PharmD) preferred.
- Experience facilitating meetings and driving consensus and results.
- Excellent leadership, communication (verbal and written) and collaboration skills.
- Proven ability in medical/technical writing.
- Labeling experience (CCDS, US, EU, UK, other major markets) in rare diseases, oncology and/or vaccines is desirable.
- Experience with TPL work for early development programs and identified life-cycle programs.
- Sense of urgency regarding FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations.
- Integrity: overriding commitment to integrity and high standards for self and others.
- Results orientation
- Strategic orientation: ability to link company and departmental visions with daily work
- Interact effectively as a member of the Regulatory sub-team, communicating effectively on strategies to the Global Labeling Committee and collaborating with business partners, including affiliates and third parties.
- Flexibility/adaptability: ability to adapt to, and work effectively within, a variety of situations and with various individuals and groups.
- Relationship building, teamwork and cooperation: builds and maintains strong working relationships with colleagues.
Experience
- 7-10+ years in biotech/pharmaceutical industry; 5-7+ years in global labeling/regulatory with global strategic leadership responsibilities.
- Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings.
- Strong knowledge of current global regulations, including specifically: e.g. vaccine development regulations and registrations pathways.
- Previous experience in oncology or rare disease is highly preferred
- Strong experience with CTD format and content regulatory filings
- Direct experience authoring, maintaining, and governing CCDS is required, including ownership of global labeling updates and coordination of downstream implementation across regional labels.
- Exceptional written and oral communication
- Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.)
Core Competencies
- Knowledge of global regulatory requirements relevant to drug development, global labeling, and post-marketing
- Demonstrated problem-solving ability with risk analysis and sound decision-making.
- Strong collaboration skills, with experience working in global, cross-cultural, matrix environments.
- Organizational skills to interact seamlessly both internally and externally on compliance matters.
- Proficient regulatory knowledge, including scientific concepts within labeling and their global implications.
- Effective communication skills for explaining concepts, options, and impacts.
- Attention to detail with the ability to think strategically.
- Fluency in English (verbal and written); additional languages would be an asset.
While candidates located in the EST time zone are strongly preferred, candidates in other U.S. time zones who have the flexibility to provide coverage during EST hours will also be considered.
What you'll do
- Global labeling experience to provide labeling strategy support across labeling for CCDS, US, EU, Rest of World (ROW), and other major markets.
- Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.
- Lead the TPL development for early-phase assets.
- Develop labeling content, format and accountability for regulatory submissions (MAAs) and related supplements and amendments. Ensure that new labeling text meets regulatory labeling requirements.
- Support the project teams with Rest of World ROW labeling assessments against the CCDS and preparation of Health Authority (HA) responses.
- Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
- Effectively communicate the regulatory labeling strategy, risks, mitigation strategies and overall plans to the Global Regulatory Science Leadership Team, Project Development Teams and senior management, as relevant.
- Provide input for the end-to-end labeling process.
- Ability to lead and manage labeling team meetings, driving strategic discussions and managing content.
- Provide coverage, as needed, on other products during peak periods or during absences of other team members.
Pay
Parexel didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
This is an opportunity to shape global labeling strategy, lead governance processes, and ensure patients worldwide receive accurate and compliant product information. You will work across diverse markets, influence external landscapes, and contribute to innovative campaigns in a dynamic, collaborative environment.
From the posting
About Parexel
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Are you experienced in leading the strategy behind how life-changing therapies are communicated to the world, ensuring innovative products are supported by clear, compliant, and high-quality documentation that enables safe and effective use across global markets?
Parexel is seeking an experienced and highly motivated Senior/Global Regulatory Labeling Strategist to play a pivotal role in shaping global labeling strategy across a diverse portfolio of innovative therapies. This highly visible position offers the opportunity to lead complex labeling initiatives from early development through post-approval lifecycle management, working at the intersection of regulatory strategy, scientific communication, and product development.
This is an exceptional opportunity for a labeling professional who wants to make a meaningful impact on global regulatory strategy, influence product development decisions, and work across a broad range of products, therapeutic areas, and international markets.
Equal opportunity, accessibility and legal noticesParexel's statements, word for word
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US5 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $111,000 | $156,500 | $176,500 |
Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 81 open Labeling & Promotion roles on Regulatory Jobs, with the titles they carry most. Not Parexel's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 44 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions19
- Collaboration and leadership19
- GMP and compliance4
- Documentation and SOPs3
- Data and digital systems2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
From Regulatory News
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By discipline
- Regulatory14 78%
- Quality3 17%
- Compliance & Safety1 6%
By level
- Senior & Principal14 78%
- Manager2 11%
- VP & Executive1 6%
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Senior / Global Regulatory Labeling Strategist at Parexel
Open until filled.