Global Regulatory Manager / 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 General Medicine 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