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Regulatory Affairs Specialist

Job Brief:

We are seeking a Regulatory Affairs Specialist to join the registration team of a leading pharmaceutical company. The successful candidate will work on the preparation and maintenance of eCTD dossiers for the EU and US markets, ensuring compliance with international regulatory standards. This is a unique opportunity to contribute to the development of life-changing products in a collaborative and innovative environment.

Responsibilities:

Prepare and maintain product registration dossiers in eCTD format for EU and US regulatory submissions.
Coordinate with clients, manufacturers, and subject matter experts to gather and manage the necessary data for registration.
Provide expert advice to internal and external stakeholders on regulatory matters, including responses to health authority queries.
Represent the regulatory function in cross-functional project teams, ensuring compliance requirements are integrated into product development plans.
Monitor and implement changes in regulatory guidelines and ensure their application in current processes (Regulatory Intelligence).
Oversee regulatory changes and manage the lifecycle of products to ensure ongoing compliance.
Lead initiatives to enhance regulatory processes and contribute to continuous improvement within the department.
Collaborate closely with Quality, Operations, and other departments to maintain compliance and streamline workflows.
Proactively propose and implement regulatory strategies or solutions to address challenges related to projects and products.
Review and evaluate change control requests, ensuring timely notification of supporting data for variations.
Ensure accurate and timely submission of product variations through client coordination.
Support the company during inspections from health authorities by providing regulatory expertise.

Requirements and Skills:

Bachelor’s degree in Health Sciences (Pharmacy, Chemistry, or a related field).
Proven experience in Regulatory Affairs within the pharmaceutical industry.
Strong knowledge of eCTD dossier preparation and submission processes for the EU and US markets.
Proficiency in spoken and written Spanish and English.
Excellent understanding of international regulatory standards (ICH, EU, US).
Strong project management and organizational skills, with the ability to manage multiple priorities effectively.
Proactive mindset with the ability to propose solutions and strategies to complex regulatory challenges.
Collaborative approach with strong interpersonal skills to work across teams and departments.

Next steps:

Do you consider yourself the ideal candidate for this role? If so, take the next step and apply now. Our team will take care of the rest.