Specialist/Sr. Specialist, Regulatory Affairs - Labeling
Hikma Pharmaceuticals Prikaži sve poslove
- Zagreb
- Stalni radni odnos
- Puno radno vrijeme
- 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.
- 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
- 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