Are you someone with experience in leading submissions of new registrations, variations, and license maintenance of medicinal products? We have an exciting new opportunity for you to join J&J as a Regulatory Affairs Manager in Budapest, Hungary.
We are looking for someone who will be responsible for leading the coordination, compilation and submission of new registrations and product license maintenance activities in Hungary, Czech Republic, and Slovakia! This is a fixed term maternity cover.
You will also ensure that local practices and SOPs are developed to effectively lead the regulatory function and provide regulatory advice to and collaborate closely with internal and external partners.
+ This role will be leading product maintenance activities like variations, renewals, new registrations of medicinal products.
+ Ensure all regulatory compliance expectations
+ Providing guidance on the NPD approval processes to marketing colleagues Participation in strategic regulatory planning and give regulatory and legislation insights
+ You will work with CE cluster and EMEA Regional R&D and local teams thus ensuring local needs are considered in Global / Regional regulatory strategies which support the strategic planning process.
+ To provide regulatory intelligence and lobbying activities like collaborating closely with local market-based colleagues, professional staff at regulatory agencies, etc. to facilitate the review and approval of regulatory submissions.
+ Active role in the interpretation of legislation in Hungary and supervising CZ/SK local law
+ Monitoring of emerging legislation changes affecting all business areas of the Consumer Healthcare Division and communication to internal customers
+ You will act as the partner and advisor for business, providing cooperation with business in the development of the regulatory strategy and approval of promo materials
+ You will have experience in submission of registrations and product license maintenance in the Czech Republic Hungary and Slovakia!
+ Good Knowledge and experience in regulatory tasks for medicinal products. Understanding of cosmetic market and medical devices’ legislation would be of advantage
+ Confident and clear in communicating technical expertise, in cross-functional meetings and in discussions with regulatory authorities etc.
+ Strong interpersonal and time leadership skills and ability to work on multiple projects.
+ Proven commercial focus and eye for the business that will enable him/her to thrive in a fast-paced, multi-layered, results-driven environment.
+ Possesses a Global approach with an ability to make decisions based on broad standards; follows global trends and assesses local impact; develops global networks and demonstrates horizontal leadership.
Languages: Proficient Hungarian and English.
Location: Budapest, Hungary
Johnson & Johnson Kft. (7160)