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Regulatory Affairs Manager Poland & Baltics

Firma: Michael Page

Miasto/Region:Warszawa / mazowieckie


Forma Zatrudnienia:dowolna


Treść oferty:

Kogo szukamy / Profile description:

  • Minimum 10 years experience in pharmaceutical industry, including proven track record on independent Regulatory Affairs role with good understanding of Quality Assurance and PV
  • Master degree in pharmaceutical, medical, biology, chemistry or related field
  • Practical knowledge of Pharmaceutical Law and any regulations governing the registration of medicinal products, medical devices and food supplements on the Polish and European level
  • Fluent English and computer literacy as a must-have
  • Self-starter full of initiative and drive to bring solutions and make the things happen
  • Ability to manage priorities with strong sense of urgency and flexibility
  • Excellent influencing skills combined with collaborative approach to deal with multiple stakeholders
  • Experience in conducting official correspondence with competent authorities
  • Documented ability to operate in global, matrix structure and cross-functional teams on daily basis

Opis stanowiska / Job description:

  • Preparing and submitting the registration documents to the competent authorities
  • Approving designs of packaging, leaflets and serving as compliance advisor on promotion materials
  • Budget management
  • Acting as Local Safety Officer responsible for processing the information about adverse reactions/events and other pharmacovigilance related issues
  • Submitting reports to the competent authorities
  • Organising pharmacovigilance training for all employees in the entrusted geographic area
  • Serving as focal point who closely cooperates with global Quality Assurance teams in case of any critical situations
  • Notifying local authorities, distributors and clients about the agreed product withdrawal strategy
  • Coordinating local complaints about reported deviations (i. e. transport and temperature)
  • Creating and updating local Quality Assurance operating procedures based on global guidelines and local adjustments
  • Monitoring and ensuring all regulatory affairs, PV and quality activities performed in Baltic states and Ukraine by external providers are in line with company's procedures and local law

Oferujemy / We offer:

  • Strategic role in the organisation with local and global exposure and regional responsibility
  • High working standards and vibrant international environment
  • Significant empowerment within medium-sized innovative company

Podsumowanie / Job summary:

Regulatory Affairs Manager as a member of local Management Team, reporting directly to General Manager plays a key role in regulatory affairs, quality and drug safety processes management. He or she is responsible for Poland, Baltics and Ukraine.

Już złożyłeś aplikacje na tę ofertę aplikuję 1 wyświetleń oferty [Regulatory Affairs Manager Poland & Baltics Warszawa]

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