**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
We are currently recruiting a:
**Regulatory Affairs Operations specialist**
The Regulatory Affairs Operations specialist is part of the Corporate Regulatory Affairs team and is responsible to coordinate and execute regulatory activities related to the regulatory systems in place at Recordati Globally.
The Regulatory Affairs Operations specialist is responsible to:
- Manage Regulatory Databases (i.e. Documental Management System, Registration Tracking System, EMA xEVMPD Database)
- Dispatch submission to the relevant authorities through dedicated web portals (i.e. CESP, EMA, PSUR Repository, MHRA portal, FDA Gateway) or affiliate accordingly
- Perform post-submission processing activities such as receiving acknowledgment from authority of submission receipt; archiving electronic receipt; communicate submission receipt to key stakeholders
- Manage the creation, review, approval, distribution of QMS documentation, including procedures and work instructions
- Provide expertise and knowledge to support system users
- Provide mentoring and training to department in specialist areas, as required
- Coordinate implementation and maintenance of global publishing systems (including system testing and validation) and processes
- Manage planning and publishing timeframe of any specific submission, defining priorities and timelines
- Coordinate preparation of reports/product filings for different departments (i.e. Annex H for Pharmacovigilance, Marketing Authorization Status for Regulatory Affairs)
- Manage and maintain xEVMPD database
**_Requirements_**
- 1 years of experience in eCTD publishing sequences, Extedo tool preferred
- Proficiency in use of electronic submission publishing tools and/or document management systems, including knowledge on Computer System validation
- Knowledge of most important guidelines for eCTD preparation and submission (i.e. European, FDA, Canadian, Gulf Council Countries, TGA)
- Veeva Vault and Extedo tool Experience
- Works independently to drive publishing process for routine submissions
- Ability to use Excel, Adobe, Microsoft Word, PowerPoint
- Expert in managing deadlines and priorities
- Analytical and problem-solving skills
- Good organization skills and attention to detail
- Fluent in English
- 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._