Regulatory manager
Regulatory manager
What we offer:
- Excellent professional opportunity
- Internal promotion opportunities
- Professional environment
- Competitive benefits package
- Work-life balance
- Home office possibility
Main responsibilities:
- Managing all regulatory processes for CHC medicines, food supplements and medical devices, incl. management of product registration documents (procedures NP, MRP, DCP), and coordination of all regulatory submissions and commitments, to obtain the approval decisions
- Maintaining accurate records of all on-going / closed regulatory procedures.
- Ensuring that the Labelling, SmPCs, and Package leaflets are updated and accurate
- Provides support to the other departments, concerning the launch plan, planning of variations, implementation of changes on the market, discontinuation of marketed products.
- Completes company data bases according to the internal procedures
- Closely work with the Medical team to ensure an optimal regulatory strategy for new product and/or new indication
- Ensuring compliance of promotional materials to current regulatory knowledge, legal requirements and procedures
- Supporting CHC Hungary in the development of uniform processes, optimization of regulatory activities by collaborating with managers and other colleagues; sharing knowledge and best practice on regulatory processes
- Working with other global functions in the performance of business assignments: Medical, PV, Communication, Public Affairs, Marketing, Logistics, Legal, Quality, manufacturing sites, delivering regulatory data and expertise
- Ensuring compliance with established procedures and regulatory requirements regarding distribution, marketing, logistics & medical department
Background and experiences:
- Master degree in the field of pharmacy, medicine, biology, chemistry or related
- Minimum 1 year of work experience in a similar position in the pharmaceutical industry
- Knowledge of Polish and European regulations in the field of pharmaceutical law
- Strong ability to work independently
- Strong problem solving skills
- Effective communication skills to interact with diverse groups and individuals
- Ability to build strategic relationships
- Native speaker of Hungarian and very good command of the English language
Location: Budapest XIII. district
