More jobs:
Global Regulatory Affairs Labeling & Promotion Specialist
Job in
Cary, Wake County, North Carolina, 27518, USA
Listed on 2026-07-10
Listing for:
Advanced Recruiting Partners
Full Time
position Listed on 2026-07-10
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Global Regulatory Affairs Labeling & Promotion Specialist
Remote | Contract Opportunity
Advanced Recruiting Partners (ARP) is seeking an experienced Global Regulatory Affairs Labeling & Promotion Specialist to support a global pharmaceutical organization. This is an exciting opportunity for a regulatory professional with expertise in product labeling, promotional review, and regulatory compliance to play a key role in supporting marketed products throughout their lifecycle.
Key Responsibilities- Develop, maintain, and update global product labeling documentation throughout the product lifecycle.
- Support global regulatory labeling strategies to ensure compliance with applicable health authority regulations and company objectives.
- Review and approve promotional and advertising materials to ensure compliance with regulatory requirements and approved product labeling.
- Partner cross-functionally with Regulatory Affairs, Medical Affairs, Marketing, Legal, Compliance, and Quality teams.
- Support regulatory submissions related to labeling updates and promotional materials.
- Participate in risk assessments and provide regulatory guidance on promotional communications.
- Develop, update, and maintain SOPs, work instructions, and internal guidance documents.
- Provide regulatory support for promotional review systems and electronic document management platforms.
- Support internal audits, inspections, and regulatory readiness activities.
- Bachelor's degree in Life Sciences or a related scientific discipline.
- 4+ years of pharmaceutical regulatory affairs experience.
- Minimum of 2 years of experience in global labeling and/or promotional regulatory review.
- Strong knowledge of global regulatory labeling requirements and U.S. advertising and promotion regulations.
- Experience interpreting FDA and international regulatory guidance.
- Familiarity with the drug development process and lifecycle management.
- Excellent project management and organizational skills with the ability to manage multiple priorities.
- Strong communication and collaboration skills in cross-functional environments.
- High attention to detail and commitment to regulatory compliance.
- Experience supporting global labeling documents, including Core Data Sheets, prescribing information, patient labeling, and product labeling updates.
- Experience with promotional review platforms such as Veeva Promo Mats or similar electronic review systems.
- Experience supporting regulatory inspections and compliance initiatives.
- Microsoft Office Suite
- Adobe Acrobat
- Veeva Promo Mats (preferred)
- Work with a globally recognized pharmaceutical organization.
- Collaborate with highly experienced cross-functional teams.
- Contribute to high-impact regulatory initiatives supporting innovative therapies.
- Fully remote opportunity with a competitive compensation package.
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