Regulatory Affairs Associate Maternity leave

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 peoples 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 global 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 verify compliance with regulatory requirements.
• Track service agreements.
• Track and archive regulatory submissions.
• Support Clinical Operations with public database disclosures such as .
• Ensure that the regulatory database for assigned projects in the region is always up to date.
• Stay up to date with the latest regulatory requirements in the region.
• Inform key stakeholders such as Commercial Business Development and Top Management about the regulatory status in the relevant area.

The challenge!

• Coordinate the preparation and review of regulatory documentation for international submissions.
• Manage regulatory lifecycle activities across the product portfolio.
• Ensure compliance with regulatory timelines for variations renewals and amendments.
• Work closely with internal teams and local affiliates to support national submissions.
• Oversee the archiving and traceability of essential regulatory documentation.
• Support regulatory activities related to US clinical trials.
• Verify the regulatory and documentary compliance of clinical sites when required.
• Maintain clear and proactive communication with internal stakeholders regarding the regulatory status of projects.

What do you need

• Bachelors degree in Health Sciences preferably Pharmacy although degrees in Chemistry Biology Biochemistry or related fields will also be considered.
• 3 years of relevant experience preferably in a regulated industry ideally within the pharmaceutical industry.
• Fluent English both written and spoken.
• Additional languages will be considered a plus.
• Basic knowledge of international standards related to drug registration and drug development including ICH GCPs regulations and directives.
• Knowledge of international markets and distribution business will be considered an asset.
• Experience with or understanding of eCTD documentation preparation.
• Knowledge of regulatory documentation related to clinical sites and clinical trials.
• Willingness to travel.
• A profile with initiative proactivity autonomy decisiveness and strong attention to detail.

Do you think this job is not for you

We encourage you to stay tuned for future opportunities at Exeltis and to share this vacancy with people in your network who may be a great fit. Your next professional challengeor someone elsesmight be closer than you think!

COMMITMENT TO EQUAL OPPORTUNITIES

At Exeltis we are committed to equal opportunities and to building diverse and inclusive workplaces. All applications will be considered regardless of gender gender identity or expression sexual orientation marital status age ethnicity nationality religion beliefs disability or any other characteristic protected by applicable law.