Regulatory Affairs Specialist & NIP Deputy
With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, 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.
- Support of regulatory strategy;
- Preparation and submission of Marketing Authorisation, variation and renewal applications (CP, DCP, MRP and NP);
- Support in managing early and successful market entry of new products in compliance with current legislation;
- Monitoring the life cycle of medicines and other pharmaceutical products, ensuring product registration updates;
- Evaluation and approval of packaging and promotional materials;
- Management of the database of pharmaceutical questions posed to the company;
- Liaison with national authorities, manufacturers, licensors and licensees;
- Preparation and submission of product dossiers for the Export area;
- Pricing and Reimbursement applications;
- Support in the revision of Regulatory Affairs procedures.
- Supervision, monitoring and control of Pharmacovigilance service provider activities;
- Submission and implementation of safety variations and urgent safety restrictions;
- Distribution and submission of PSURs;
- Participation in audits and inspections;
- Support with submission and implementation of Risk Management Plans (RMPs);
- Support in the elaboration and revision of Pharmacovigilance procedures;
- Elaboration and revision of SDEAs;
- Providing Pharmacovigilance training especially for non-PV staff.
- Maintenance of the Pharmacovigilance System Master File (PSMF);
- To assume the functions of NIP Deputy only if both NIP and NIP Deputy are simultaneously absent.
- Master’s degree in Pharmaceutical Sciences or an equivalent Health-related area.
- Proven experience in Regulatory Affairs and Pharmacovigilance;
- Strong knowledge of national and European pharmaceutical legislation;
- Experience in regulatory submissions (MAAs, variations, renewals) and interaction with regulatory authorities;
- Experience with the Veeva Vault tool would be an asset.
- Management and submission of regulatory dossiers (CP, DCP, MRP, NP);
- Knowledge of GMP, GDP and GVP requirements;
- Experience with electronic submission systems (eCTD, CESP);
- Strong critical thinking, problem-solving and prioritisation skills.
- High sense of responsibility and attention to detail;
- Strong organisational and planning skills, with ability to meet deadlines;
- Proactivity, autonomy and team spirit;
- Excellent communication and interpersonal skills.
- Portuguese (fluent);
- English (fluent, written and spoken).
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.
If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.
