Regulatory Affairs Specialist (M/F)

Tecnimede Group is a Portuguese multinational company, with more than 40 years of history in the life cycle of the drug product for human use - development, production and marketing - with the mission to improve and preserve the human life and the human health.

Exporting to more than 100 countries worldwide, it is present in 6 countries (Portugal, Spain, Italy, Marocco, Columbia and Brazil) with strong focus in expanding internationally and building strategic partnerships.

We are looking to reinforce our team with a regulatory affairs specialist to support our subsidiary in Italy.

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:

-Minimum of 2 years of experience in a similar role;

- 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;

-Availability to travel to Italy;

- Fluency in English.

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