Global Regulatory Lead

Key Responsibilities

• Drive the development of RA strategies for new product submissions starting from early stages of pre-clinical development to life-cycle management in order to ensure “label-driven” product development with understanding the portfolio
• Be a strategic partner to Business unit
• Enable to submit any typies of marketing authorization applications
• Ensure that regulatory obligations for marketing authorisations are met
• Provide a point of contact for EMA, national European Regulatory Authorities, FDA and other Competent Authorities
• Coordinate all regulatory aspects related to Gedeon Richter’s Clinical Trial Applications
• Collaborate with internal and external teams to provide Global Regulatory Advice (e.g. to GM, R&D, manufacturing, clinical, non-clinical, medical, project teams and others)
• Provide supervision and support to other RA professionals and administrative support staff
• Ensure compliance by coordinating all required RA post-approval activities
• 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

Ideal profile

• MSc degree in life sciences, ideally with a PhD
• Substantial European RA experience – including practical experience with European regulatory procedures and interactions with regulatory authorities
• 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
• Excellent verbal and written communication and presentation skills in English

What 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.

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

New molecules, new medicines, new processes, and new technologies - Richter invites innovative minds to exploit their full capacities. With our research and development base with 1000 professionals, we have one of the most significant innovation centres not only in Hungary but in the entire Central and Eastern European region. In addition to applied scientific work, we also support individual research fields and topics, as well as publishing activities and participation in scientific life.

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