Regulatory Affairs Specialist/International
3 giorni fa
**The contex/Company description**
With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest - we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow - with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life
**Regulatory Affairs Specialist**
- new Marketing Authorization Applications
- line-extension,
- renewal of marketing authorizations
- variations of type IA, IB, II (grouping and worksharing procedure) or equivalent in accordance with national legislation
- notification of start/end of marketing
- marketing authorization transfer
- review and approval of printed material (artworks and mock-ups)
Based on the products assigned, the Regulatory Affairs Specialist will also:
- coordinate the preparation of discussions and negotiation with various Regulatory Agencies;
- participate in the management of core dossiers of corporate products, including gap-analysis activities, to support the registration in different territories worldwide, collaborating with the relevant departments;
- coordinate with the group's affiliates, licensees and consultancy companies and will maintain relations with the Regulatory Authorities;
- monitor the legislation in force and define a plan and costs of the required activities
**Skills and experiences required**
- atleast 2 years experience within the regulatory affairs area of multinational pharmaceutical companies (preferably "parent companies") or regulatory consultancy companies operating internationally
- Scientific degree
- High level knowledge of English
- Experience in the use of IT systems for the management of data and regulatory documents (RIMS, DMS, eCTD platform), eCTD platforms and regulatory document management
- At Recordati we believe in people Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential._
- We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief._
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