Apply now »

Regulatory Affairs Specialist

ID:  1237
Date of Posting:  Feb 15, 2025
Business Area:  Regulatory Affairs
Job Type:  Direct Employee
On site / Remote / Hybrid:  On Site
Location: 

Campoverde Aprilia, IT

Territory: 
Full-Time or Part-Time:  Full Time
Seniority:  Mid-senior

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.

Job Purpose

The position to be covered is in the RA department of Recordati Campoverde site, reporting to the RA Manager.

Responsible for regulatory affairs activities to assist in the submission of regulations, annual reports, registrations and lists. Ensure compliance with applicable regulations by jurisdiction, guidelines and standards. Assist in the creation and maintenance of regulatory files.

Key Responsibilities

  • Writing and updating EU-CTD (module 3.2.S), US-DMF type II, J-DMF.
  • Writing and updating documentation to be submitted to EDQM (CEP).
  • Customer technical support.
  • Worldwide submission of regulatory documentation.
  • Submission in electronic format in EU, US and ROW countries.

Required Education

Degree in Chemistry or Pharmaceutical Chemistry

Required Skills and Experience

  • Basic knowledge of EU and US regulatory procedures
  • Basic knowledge of API analytical techniques
  • GMP Basic knowledge
  • Good communications skills
  • Curiosity, precision and organization
  • Proven ability to work on own initiative or in a cross-functional Team.
  • Skills: Microsoft Office, Documentation management systems (preferable Veeva Vault), English intermediate level

Required Languages

Fluent 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.

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.

Apply now »