Title:  Sr. Specialist, Labeling

Senior Labelling Specialist, Regulatory Affairs, Injectables (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 centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

In this role you will be responsible for labeling development and for regulatory activities related to labeling and artwork/mock-up creation. Also, you will be responsible for providing expert support to other members of the regulatory department as well as to other departments in line with regulatory labeling guidances/regulations.

Key responsibilities:

• Preparation of labeling and artwork for packaging components (carton, label, package information leaflet) for United States (US) and Europe (EU) markets
• Format and edit labelling in accordance with health authority guidelines and regulations with quality and accuracy
• Being flexible to shift labeling priorities including labeling development, proofreading and updating based on internal, partner or Health Authority requests
• Prepare and critically review labeling files for labeling at all stages of the development life cycle (including initial submission, deficiency and launch) and understanding unique requirements at each phase
• Interface with project teams, internal stakeholders and manufacturing sites to create and update labeling for submissions, respond to deficiencies or reference listed drug (RLD) updates
• Review, maintenance, management and version control of SPL files for drug listing submissions
• Work with vendors and graphic designers to obtain and approve artwork files and proofs
• Support of team in accomplishing continuous improvement objectives and identify process improvements
• Provides regulatory expertise while participating in product discussions and projects
• Independent work in all duties and support to less experienced colleagues
• Responsible for all product-specific activities (compliance, monitoring implementations of procedures, regulatory/labeling intelligence)
• Ensure optimal compliance to global labeling regulations, to minimize risk for the patient and company business
• Responsible for regulatory and labeling strategy and provision of regulatory/labeling support, including opinion or advice to all other stakeholders
• Continuous monitoring of guidelines, CFR, MaPP, FDA, EMA, EDQM, MHRA, and National Authorities home pages

What we expect:

• Bachelor’s Degree, or advanced degree, in Pharmacy, Biotechnology, Faculty of Science or related studies
• Experience with labeling/artwork in pharmaceutical business
• Fluency in English language (spoken and written)
• Thorough proficiency in MS Office
• Demonstrated ability to handle multiple tasks in a fast-paced environment
• Proactive working approach and developed stakeholder management skills
• Excellent interpersonal and communication abilities
• Experience and knowledge in EU/US regulation (searching through guidelines, EMA and national authorities pages)
• Ability to organize, plan, and prioritize workload to accomplish goals and objectives with minimal supervision
• Excellent attention to detail
• Ability to work independently with minimal to no guidance with good judgement and decision-making skills

What we offer:

• Permanent full-time position
• A dynamic work environment
• Opportunities to interact with colleagues at all levels, as well as clients and customers
• Competitive compensation package
• Annual health check-up and incident insurance policy
• Monthly food and travel allowances