In a nutshell ?

Position: Regulatory Affairs Associate – Temporary (maternity leave)

Location: Madrid (on-site)

Experience: 3+ years

Want to know more? ?

Exeltis is a pharmaceutical company committed to improving people’s health and well-being through the development, manufacturing, and commercialization of innovative, high-quality products.

We are looking for a Regulatory Affairs Associate to support the regulatory development of pharmaceutical products and the lifecycle management of the portfolio, ensuring that submissions, variations, amendments, and renewals are filed on time and in full compliance with regulatory requirements. This role will also provide support, when needed, to Clinical Operations activities in the US.

What are we looking for? ?

The selected candidate will play a key role in regulatory activities, including:
- Support general and local teams in preparing eCTD modules for regulatory applications.
- Prepare eCTD documentation for regulatory submissions.
- Archive essential documents, such as Product Information, in line with company procedures.




- Provide local affiliates with the documentation required for national submissions.
- Ensure that essential post-approval dossier information is shared with the relevant departments according to applicable procedures.
- Prepare the documentation required for the submission of administrative variations, quality-related variations, non-clinical and/or clinical variations, as well as amendments.
- Compile and prepare the documentation needed for the submission of safety reports in collaboration with the Exeltis Pharmacovigilance department.
- Submit renewals on time and communicate timelines to all relevant partners.
- Track the qualification of clinical sites, including the collection, review, and preparation of regulatory documentation such as Form 1571, financial disclosure forms, and debarment/restricted list reviews.
- Perform visits, when needed, to sites involved in US clinical trials to veri

📌 Regulatory Affairs Associate (Madrid)
🏢 Insud Pharma
📍 Madrid