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Regulatory Affairs Specialist

ID:  919
Date of Posting:  Sep 28, 2024
Business Area:  Regulatory Affairs
Job Type:  Direct Employee
On site / Remote / Hybrid:  Hybrid
Location: 

Hemel Hempstead, GB Lyon, FR Puteaux, FR

Territory: 
Full-Time or Part-Time:  Full Time
Seniority:  Entry level

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.

Job Purpose

The Regulatory Affairs Specialist is crucial in coordinating and supporting product development and life cycle maintenance activities of the Recordati portfolio for the Recordati Rare Disease (RRD) products. They will support and collaborate with Regulatory Affairs Managers and Directors on Document archiving, Document processing, country coordination with product leads, and process review.  They will monitor the Major Health Authority websites and inform the team of Guidance realizations and relevant changes. Strong attention to detail, team work attitude and willingness to learn are essential for the success of this role.

Key Responsibilities

These include, but are not limited to:

  • Maintenance of Regulatory database: naming and archiving files related to Regulatory procedures, ensuring the quality and compliance of documents are maintained and ready for inspection
  • Under supervision, prepare and manage submissions and follow-up of product registrations or any other regulatory activity, ensuring timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Communicate with affiliates, outside companies and Health Authorities.
  • Support other departments, affiliates, and third parties in obtaining any required regulatory information.
  • Monitoring and sharing global regulatory guidelines and requirements to support the regulatory strategies and ensure compliance.
  • Ensure all relevant databases and activity trackers are populated within agreed timelines.
  • Provide technical support on document preparation.


These responsibilities are crucial for ensuring that products meet regulatory requirements, are developed in accordance with best practices, and ultimately reach the market in a compliant and timely manner. 

Please take note that staff management, budget responsibility and training responsibility will not be a requirement in this role. 

Required Education

  • Bachelor's degree in Health Sciences or related field.
  • Junior graduated in Health Sciences.

Required Skills and Experience

  • Ability to work as part of the regulatory team to meet the objectives
  • Ability to research regulatory requirements

Technical Competencies

  • Computer skills (such as MS Office, databases, Document Management System)

Required Behaviours and Competencies

  • Ability to work under tight timelines to meet deadlines and business objectives
  • High degree of attention to detail. Analytical skills and ability to summarize
  • Ability to clearly communicate verbally and in writing

Required Languages

  • 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.

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 »