Global Regulatory Lead

Törzskönyvezés, beadás, forgalomba hozatali engedély, termék életciklus, drug regulatory affairs

Your new company

We are looking for an experienced Regulatory Lead to handle global projects for our pharmaceutical partner.

Your new role

  • oversee the product lifecycle management activities of the company (mostly generic & biosimilar products); closely work together with regulatory teams within the company (with regards to Clinical Trial Applications, Marketing Authorisations, labelling, etc.) and represent & advocate Regulatory Affairs on strategic meetings
  • take part in the development of Regulatory Affairs strategies for new products, from early stages of development until lifecycle management
  • act as point of contact for competent authorities, including but not limited to EMA, national regulatory authorities and FDA; coordinate and lead communication with them
  • provide input from RA aspect to other departments within the company, as needed; provide supervision and professional support to RA colleagues as needed
  • track and follow up on EU and national regulations that might influence the effective life of products

What you’ll need to succeed

  • an MSc (or higher) degree in Life Sciences
  • at least 5 years’ working experience within Regulatory Affairs – worked with EMA, familiar with most processes
  • strong written and verbal English skills, fit for negotiation
  • ability to handle complex regulatory issues and prioritise activities; able to think strategically, consider multiple factors at once
  • project management and analytical skills; strong communication skills

What you’ll get in return

  • stable, well-established company, offering professional development and training
  • multidisciplinary teams
  • excellent benefits package – company car, medical services, insurance, etc.
  • focus on work-life balance and hybrid working conditions in the long run as well

What you need to do now
If you have the required professional background and interested in this role, click on the „Apply” button.

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Job Type
Life Sciences

Talk to a consultant

Talk to Altmann Vivien, the specialist consultant managing this position, located in Budapest
Budapest, Szabadság tér 7, Bank Center

Telephone: 36703802102

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