Senior Labelling Specialist, Regulatory Affairs, Injectables (m/f/d)

Zagreb

Hikma is a multinational pharmaceutical company, with a local presence across North America, MENA and Europe, manufacturing and supplying a broad range of generic, specialty and branded pharmaceutical products.
With over 30 manufacturing plants, 9 R&D centres, and a workforce of 9,500 employees, we ensure access to our high-quality medicines and put better health within reach, every day.
In this role you will be responsible for labelling development and for regulatory activities related to labelling 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 labelling guidance/regulations.

Key responsibilities:

preparation of labelling and artwork for packaging components (carton, label, package information leaflet) for United States (US) and Europe (EU) markets in accordance with health authority guidelines and regulations with quality and accuracy
prepare and critically review labelling files for labelling at all stages of the development life cycle (including initial submission, deficiency letters and launch) and understanding unique requirements at each phase
interface with project teams, internal stakeholders and manufacturing sites to create and update labelling for submissions,
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
ensure optimal compliance to labelling regulations, to minimize risk for the patient and company business
continuous monitoring of guidelines, CFR, MaPP, FDA, EMA, EDQM, MHRA, and National Authorities home pages
independent work in all duties and support to less experienced colleagues

What we expect:

Bachelor’s, or advanced degree, in Pharmacy, Biotechnology, Faculty of Science or related studies
experience with labelling/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
excellent interpersonal and communication abilities
experience and knowledge in EU/US regulation
ability to organize, plan, and prioritize workload to accomplish goals and objectives with minimal supervision
excellent attention to detail

What we offer:

permanent full-time position
a dynamic work environment
opportunities to interact with colleagues at all levels
competitive compensation package
annual health check-up and incident insurance policy
monthly food and travel allowances
fully covered sick leave up to 42 days
free drinks, fruit and parking slots

Senior Labelling Specialist, Regulatory Affairs, Injectables (m/f/d)

Hikma d.o.o.

Hikma d.o.o.

Prosječna neto plaća u kategoriji Farmaceutika i biotehnologija iznosi 1292.58 EUR*