Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
To reinforce our team we are looking to fill the following position at our Lumiar site:
Regulatory Affairs Technical Expert (M/F)
The Regulatory Affairs Technical Expert will assure the execution of the agreed regulatory strategy to support new Marketing Authorization Application and Life Cycle Maintenance Activities, the submission and updating of Product Dossiers (drug substance and drug product) ensuring compliance with regulatory requirements.
- Ensures that the development strategy meets global regulatory requirements over
the lifecycle of the product;
- Plans and manages regulatory submissions (e.g. Drug Master Files, marketing applications and variations in compliance with filing plans, regulatory requirements and in line with business objectives;
- Manages the continuous updating of SmPCs/PILs and coordinates the labelling implementation for packaging materials;
- Provide Regulatory support to clients;
- Regular interactions with Regulatory
- Authorities regarding product related activities.
- University degree in Pharmaceutical Sciences, Chemistry or related discipline;
- More than 3 years’ experience in Regulatory Affairs with direct contact with
- Regulatory Authorities;
- Good knowledge of European regulatory legislation and submission processes;
- Good general knowledge on Quality, cGMPs, ICH guidelines and national and international legislation related to pharmaceutical products;
- Proficient spoken and written English;
- Good communication skills;
- Good human relationship and teamwork ability;
- Availability to travel abroad to support customers.
- Full time opportunity;
- Remuneration and social benefits adjusted to the job function and matching the experience;
- Excellent work environment, with a strong focus on quality.