Alternant en conformité réglementaire chez Sanofi, contribuant à la conformité mondiale des activités de santé. Collaborant avec une équipe pour développer compétences tout en soutenant l'avenir de la santé.
About the role
- Specialist/Sr. Specialist responsible for pharmaceutical labeling and artwork at Hikma Pharmaceuticals. Ensuring compliance with regulatory requirements and company standards for global markets.
Responsibilities
- Create, prepare, review, approve, and manage labeling for submission to Health Authorities (FDA, EMA, and other national authorities) based on Reference Listed Drug/Reference Medicila Product labeling, regulatory guidelines, and company requirements
- Develop and maintain labeling in SPL and PLR formats; ensure version control and compliance for drug listings and DailyMed postings
- Prepare and critically review labeling files throughout the product lifecycle (initial submission, deficiency responses, launch)
- Draft and revise artwork/mock-ups for packaging components (cartons, labels, package inserts) in collaboration with vendors and graphic designers
- Interface with project teams, internal stakeholders, and manufacturing sites to update labeling and respond to regulatory changes or deficiencies
- Monitor and implement updates from regulatory authorities (FDA, EMA, MHRA, EDQM) and ensure compliance with global labeling regulations
- Monitor and implement Reference Listed Drug/Reference Medical Product updates to assure regulatory compliance
- Submission of safety variations and variations related to labeling/artwork
- Acting as a RA lead during National phases of submissions, if predominantly labeling is impacted
- Communication with Regulatory bodies (e.g. FDA, EMA, MHRA, BfArM)
- Provide regulatory expertise and strategic advice during product discussions and cross-functional projects
- Identify and implement process improvements to enhance efficiency and quality of labeling submissions
Requirements
- Bachelor’s degree in Pharmacy, Biotechnology, Life Sciences, or related field (advanced degree preferred)
- Experience with labeling/artwork in the pharmaceutical industry
- Strong knowledge of US and EU labeling regulations, FDA Guidance Documents, ICH Guidelines, Code of Federal Regulations, and EMA requirements
- Proficiency in MS Office and familiarity with SPL/PLR formatting
- Excellent verbal and written communication skills; ability to interact effectively at all organizational levels
- Fluency in English language (spoken and written)
- Ability to manage multiple priorities in a fast-paced environment with minimal supervision
- Strong attention to detail, critical thinking, and decision-making skills
- Proactive approach and stakeholder management capabilities
Benefits
- Collaboration across teams and functions, building relationships with colleagues from different departments and regions
- Opportunity for professional growth in scientific field and global network
- Permanent full-time position
- Competitive compensation package
- Annual health check-up and incident insurance policy
- Monthly food and travel allowances
- Free drinks, fruit and parking slot
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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