Global Regulatory Lead
Employer · Gedeon Richter
Legal specialist
Licensing officer
PharmacistFull-timeBudapest
Gedeon Richter is looking for a committed and experienced professional for the position Global Regulatory Lead to drive RA strategies and ensure compliance.
Tasks
- 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
Conditions & benefits
Professional developmentGreat opportunity for professional development in an innovation driven departmentCompany reputationGreat reputation at a well established pharmaceutical firmStabilityStability and a trustworthy workplaceTeamworkWork in multidisciplinary teamsTrainingTraining and development opportunitiesMedical services and life insuranceMedical services and life insuranceSport and healthVarious sport and health opportunitiesWork-life balanceExcellent work life balance
Requirements
- 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