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