Regulatory affairs - Pharma
De peste 70 de ani, ManpowerGroup reprezinta puntea de legatura intre milioane de persoane si piata muncii, prin brandurile sale Manpower, Experis, ManpowerGroup Solutions si Right Management. Compania este prezenta pe piata din Romania din 2003, iar in acesti ani peste 400 de clienti si zeci de mii de candidati au avut incredere in noi pentru a le oferi flexibilitatea, agilitatea, talentele, competentele si oportunitatile de care au nevoie. Indiferent daca va aflati la inceput de drum, sau sunteti profesionisti experimentati, brandurile ManpowerGroup va pot oferi oportunitatile potrivite de a va dezvolta, a dobandi noi abilitati si competente, a fi expusi la proiecte pline de provocari si a creste profesional.Cerinte
• Minimum 3 years experience in a direct registration function with a pharmaceutical company.
• Demonstrated success in securing product registrations in a variety of therapeutic areas.
• Demonstrated ability in planning, problem solving, and time management.
• Demonstrated ability to work with a range of technically and culturally diverse people at all management levels, influencing them to get things done, and delivering value-added business results that meet high quality requirements within tight deadlines.
• Knowledge of local/regional regulatory processes and changes that are implemented or being considered.
• Knowledge of the local pharmaceutical industry.
• A well developed knowledge of life science and medicine as well as business, usually attained through formal education culminating in a BSc or BPharm or equivalent.
• Knowledge of how ethical pharmaceutical products are marked and the regulatory impact on promotional literature and activities.
• Good command of oral and written English communication skills.
• Responsible for driving regulatory processes in line with business/R&D objectives to ensure timely registration of new products/line extensions and variation applications of BMS products.
• Responsible for assuring that approved labelling (SPC, PL, pack) is implemented in production in accordance with local legislation.
• Drives and support Regulatory translations for Romania
• Drives and support filing clinical trial applications to the competent regulatory authority in Romania, and all following interactions, in line with BMS company policies and practices, the European Clinical Trial Directive and local legislation.
• Drives and support local projects and department related assignments.
• Responsible for identification of opportunities to improve departmental functions/processes.
• Responsible to keep up to date with the regulatory environment within the industry.
• Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases.
• Act as a key partner with the country Business function, Medical function, Clinical Operations function, Market Access function and Logistics function.
• Creates and updates local procedural documents.
• Promptly report knowledge (initial or follow-up) of any adverse event or quality product complaints associated with a product within 24 hours or one business day of becoming aware of the event, in accordance with the Company procedures.
Private life insurance