Global Regulatory Lead

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Date: Feb 27, 2024

Location: Budapest, HU

Company: Richter Gedeon Nyrt.

Join the professional team of the 120-year-old Gedeon Richter Plc., a leading pharmaceutical company in Hungary and the region!

As a supportive company,  we offer to our colleagues a broad spectrum of health and well-being services as well as proprietary facilities for leisure time and recreation. Richter employees and their families may enjoy our holiday resorts, sports fields, swimming pools, kindergartens, doctor's offices, and we also provide comprehensive health screening every two years.

Gedeon Richter is looking for a committed and experienced professional for the position

Global Regulatory Lead

Position summary

This position is the key function to lead and oversee all regulatory aspects of a major project or product of Gedeon Richter’s portfolio from early development to Life Cycle Management activities globally. He/she will collaborate very closely with project teams and other regulatory functions in order to facilitate the development of safe and effective products and shorten time to market.

Additional Responsibilities

  • Coordinate post-approval support for existing products, including co-ordination and preparation of variations to optimise the commercial life cycle of products, development of line extensions, and preparation of license renewal applications
  • Support the development and/or subsequent maintenance of product labelling
  • Co-ordinate and lead interactions with Regulatory Agencies, e.g. Scientific Advice procedures with EMA, FDA and other national Competent Authorities 
  • Track, interpret and advise on European and national regulations to maximise and protect the effective life of products
  • Provide regulatory assessment during due diligences of potential in-license projects and support business development decisions

Required skills and knowledge

  • A strong scientific background with at least a MSc degree in life sciences, ideally with a PhD;

  • A minimum of 5 years substantial RA experience – including practical experience with European and most importantly with American regulatory procedures and interactions with regulatory authorities ;

  • Experience in managing new submissions and/or maintenance work;

  • Thorough knowledge of the fundamental processes and regulatory requirements in the areas of research, drug development and marketing of innovative medicinal products;

  • Scientific and technical expertise, including the ability to develop robust regulatory plans covering all phases of drug development;

  • Detailed knowledge of and ability to interpret regulatory requirements for innovative / generic / biosimilar medicinal products in Europe and the US together with the awareness of the commercial implications of pharmaceutical regulations;

  • Proven ability to manage complex regulatory issues and prioritise activities;

  • Project management skills;

  • Analytical skills to interpret available data and make critical regulatory decisions;

  • Ability to organise and manage diverse activities in a multi-disciplinary environment, communicating with global and local groups;

  • Leadership and inter-personal skills for efficient cross-functional communication 

  • Efficiency in problem solving as applied to regulatory issues;

  • Ethical, scientific and intellectual integrity 

  • Excellent verbal and written communication and presentation skills in English.

We offer

  • Great opportunity for professional development in an innovation driven department

  • Great reputation at a well established pharmaceutical firm

  • Stability and a trustworthy workplace

  • Work in multidisciplinary teams

  • Training and development opportunities

  • Medical services and life insurance

  • Various sport and health opportunities

  • Excellent work life balance

The Richter community is looking forward to your application.

Apply now »