As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Level: Mid
- Travel: Yes
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Success Profile
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
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?
If so, we are seeking an experienced and highly motivated strategic labeling professional to join our Global Regulatory Affairs team as a temporary Global Labeling Lead. This role will work closely our client and is integral to the development and maintenance of regulatory labeling content that supports the safe and effective use of their products across international markets. The successful candidate will provide strategic leadership in labeling development, ensure regulatory compliance, and collaborate cross-functionally to deliver high-quality documentation throughout the product lifecycle.
Key Responsibilities
Labeling Strategy & Development
• Lead the creation, revision, and management of core labeling documents, including the Core Data Sheet (CDS), U.S. Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), Global Patient Leaflet, and Target Label Profile
• Drive alignment of labeling content and strategy across U.S., EU, and global regulatory teams
• Collaborate with subject matter experts to develop contingency language in response to Health Authority queries
• Facilitate timely endorsement of labeling decisions by senior leadership
Operational Oversight
• Oversee operational labeling activities, including coordination of EU/US artwork, EMA linguistic reviews, and U.S. SPL submissions
• Maintain labeling documentation within electronic document management systems (EDMS) and regulatory tracking platforms
Global Implementation & Compliance
• Support the regional implementation of CDS updates and monitor compliance across markets
• Partner with regional and local regulatory leads to address Health Authority inquiries and manage country-specific labeling variations
• Ensure audit readiness through robust version control and adherence to standard operating procedures (SOPs)
Strategic Labeling Expertise
• Interpret clinical and scientific data to inform labeling content and product claims
• Identify strategic risks and opportunities in labeling and provide guidance to cross-functional teams
• Remain current with global labeling regulations and deliver training to internal stakeholders as needed
Qualifications
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on labeling strategy and development
• Comprehensive understanding of US and European labeling regulations and systems to include regulatory tracking tools and artwork/supply chain platforms
• Demonstrated ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings
• Strong organizational, communication, and stakeholder engagement skills
• Bachelor’s degree in a scientific or medical discipline; advanced degrees are preferred
Due to the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, individuals based in the Central Time Zone will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.
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