Specialist/Sr. Specialist, Regulatory Affairs - Labeling (m/f/d)
Location: Zagreb
Hikma Pharmaceuticals purpose is to put better health, within reach, every day for millions of patients around the world. Through our global footprint of 30+ manufacturing plants, 9 R&D centres, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
We are looking for a Specialist/Sr. Specialist, Regulatory Affairs – Labeling, who will be responsible for the development, preparation, review, and maintenance of pharmaceutical labeling and artwork for global markets, including but not limited to the United States (US) and Europe (EU). This role ensures compliance with Health Authority requirements and company standards while providing expert regulatory support across departments. The position requires independent work, strategic input, and mentoring of less experienced colleagues. Join us and bring your expertise to a team where your contribution truly makes a global impact.
Key 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.
What we expect:
- 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
What we offer:
- 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
If you are collaborative, like to innovate in the way you work, care about others, and are itnerested in a career where you can make a positive impact on people’s lives, apply no later than April 22nd, 2026.
