Global Regulatory Manager / Lead
We do not base our success on impressive actions of lone heroes. We like to actively involve everyone into joint efforts and teamwork - both inside and outside their teams. We know how to work effectively and agreeably with specialists and representatives of different professions, disciplines and departments.
Currently we are looking for a
Global Regulatory Lead
to join our global regulatory team in Budapest.
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 labeling
- 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 diligence 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.
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.