Oferta pracy

Senior Regulatory Affairs Specialist

GSK

  • Warszawa

    Warszawa, Masovian
  • offer expired 23 days ago
  • contract of employment
  • full-time
  • senior specialist (Senior)
  • hybrid work
  • remote recruitment

Your responsibilities

  • Manage the regulatory affairs for a portfolio of pharma/ vaccine products including the associated maintenance of marketing authorizations and product labeling Poland.

  • Be the Regulatory responsible for the specified product portfolio. This product responsibility includes both national and central licenses and also GSK assets/ projects still in development.

  • Be the regulatory expert providing regulatory expertise on the assigned product portfolio in cross-functional settings to support the business.

  • Cooperation with various business structures in order to support business strategies in Poland.

  • Knowledge and analysis of local regulations and leading on initiatives to adapt to changing requirements.

  • Quality assurance activities for the compliance of the marketed product with the registered data, including implementation of artwork and supply chain/ distribution requirements.

  • Monitoring of available registration data on competitors' activities in accordance with the needs of the commercial part of the company.

Our requirements

  • Higher education, preferably pharmacy, medicine, biology, biochemistry, chemistry, biotechnology, possibly technical faculties.

  • Relevant experience in Regulatory Affairs area: 5 years

  • Engagement and motivation, willingness to learn and develop, attention to details.

  • Fluent English and Polish (written and verbal).

  • Computer skills – in the sense of the ease of working on a computer /with systems.

  • High interpersonal skills.

  • High own work organization skills, responsibility.

  • Experience and familiarity of working within documentation databases and team sites.

  • Knowledge of Veeva Vault system or similar regulatory management database/ system will be an asset.

What we offer

  • Career at one of the leading global healthcare companies

  • Employment contract

  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

  • Life insurance and pension plan

  • Private medical package with additional preventive healthcare services for employees and their eligible

  • Sports cards (Multisport)

  • Possibilities of development within the role and company’s structure

  • Personalized learning approach

  • Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)

  • Supportive community and integration events

  • Modern office with creative rooms, fresh fruits everyday

  • Free car and bike parking, locker rooms and showers.

  • Benefits

  • private medical care

  • life insurance

  • remote work opportunities

  • flexible working time

  • retirement pension plan

  • parking space for employees

  • leisure zone

  • extra social benefits

  • holiday funds

  • employee referral program

  • charity initiatives

  • one shorter working day

  • life Insurance

  • sport and recreation cards

  • annual bonus

  • canteen for employees at site (with discounts)

  • flexible working options available for most positions

GSK

At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. As a modern employer, we empower you to be yourself, share ideas and work collaboratively

We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

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