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