Regulatory Affairs Specialist (M/F)

At Tecnimede Group, we are driven by a clear purpose: improving people's lives through medical science and technology.

As a Portuguese multinational pharmaceutical company with a presence in six countries and products reaching more than 100 markets worldwide, we offer the opportunity to contribute to a business with global impact while building your career from Portugal.

We believe that great ideas can come from anywhere. That's why we foster a collaborative environment where initiative is valued, innovation is encouraged, and people are empowered to challenge existing ways of working and help shape the future of our organisation.

Joining Tecnimede means becoming part of a company that invests in growth not only through science and technology, but also through its people. Here, you will find opportunities to learn, develop, and build a meaningful career while contributing to a purpose that makes a difference every day.

If you are looking for a role where your work can create real impact, join us in elevating lives worth living.

We are looking to reinforce our team with a Regulatory Affairs Specialist (M/F).

Responsibilities:

- Ensure the coordination of all activities related to the regulatory area, ensuring compliance with applicable regulations and guidelines;

- Prepare and submit pharmaceutical product registration dossiers for approval by authorities;

- Keep up to date with changes in regulations and guidelines and ensure the company is compliant;

- Collaborate with internal teams in the pre-authorization phase (pharmaceutical, analytical and clinical development, and quality) and in the post-authorization phase (industrial production, pharmacovigilance, logistics, price and reimbursement and quality);

- Participate in audits and inspections, providing support and necessary information;

-Develop and update locally controlled regulatory documentation (SOP's, training materials), ensuring they are updated and proactively identify procedural gaps to implement solutions in collaboration with all relevant stakeholders.

Requirements:

- Academic training in Pharmacy, Chemistry or a related field;

- Proven experience in the pharmaceutical regulatory area;

- In-depth knowledge of pharmaceutical legislation and regulations;

- Analytical and problem-solving skills;

- Excellent verbal and written communication skills;

- Ability to work independently and in a team;

- Fluency in English.

"In accordance with the provisions of the GDPR and other legislation in force on personal data protection, the contracting company guarantees that the processing of your personal data is lawful, fair, transparent, and limited to the purposes for which your data was collected."