Regulatory Affairs (GDP Responsible Person) - Slovakia & Austria

Job description

Description

Location: Brastislava, Slovakia

Contract type: We have 2 options – part time &responsible only for Slovakia OR full time & responsible for Slovakia only or Slovakia & Austria

Salary: 32,000 EUR per annum, full time (part time will be pro-rata)

We are on the hunt for a dedicated Responsible Person to join our team based in Bratislava, Slovakia. This role will be responsible for the regulatory activities (RA) to obtain and maintain Marketing Authorizations (MAs) for medicinal products and other authorizations for non-medicinal products (e.g. medical devices, food supplements, cosmetics), in full compliance with national and European regulations and technical standards, as well as internal Corporate Standard Operating procedures and processes. The role will also be the technical leader on scientific and medical activities to ensure full compliance of advertising and promotional materials to relevant regulations and guidelines. If this sounds like an exciting new challenge for you, then read on.

With us you will:

·  Assume the role of Responsible Person according to EU GDP guideline for Procter & Gamble Slovakia & Austria, as wholesaler
·  Take ownership of, develop and continuously improve the quality management system
·  Represent, together with regulatory affairs department, Procter & Gamble as both wholesaler and marketing authorization holder
·  Ensure compliance of products with local requirements and take actions if needed
·  Maintain a training system and train local employees on Personal Health Care requirements
·  Review and align QATAs with contract manufacturers, service providers, and the PHC technical operations
·  Execute regular reviews with distributors and business partners
·  Host audits and inspections
·  Represent Procter & Gamble Slovakia & Austria as counterfeit / recall / theft contact
·  Contribute to and implement the quality strategy of Procter & Gamble

Qualifications

Apply if you have:

·  Hold a Pharmacist or Chemist Degree
·  Professional experience in quality assurance/regulatory affairs department of pharmaceutical industry (in a pharmacy or wholesale activities - essential)
·  Must fulfill the legal requirements for a Responsible Person (GDP) in Slovakia
·  Must be a Slovakian citizen
·  The ability to be flexible and adapt to changing business needs and lead changes
·  Communicate fluently in English & Slovak (German would be an advantage if considering full time)

Commitment from us

P&G’s Day 1 starts with you doing something that matters – making an impact on the world, P&G brands, and your career.

You’ll be at the core of breakthrough innovations, be given exciting assignments, lead initiatives, and take ownership and responsibility. And you’ll do this in creative workspaces where new ideas flourish. All the while, you’ll receive world-class training to help you become a leader in your field. And it’s not just about what you’ll do, but how you’ll feel: welcomed, valued, purposeful, challenged, heard, and inspired.