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, promotion and marketing - with the mission to improve and preserve human life and health.
Exporting to more than 100 countries worldwide, it is present in 6 countries (Portugal, Spain, Italy, Morocco, Colombia, and Brazil) with a strong focus on expanding internationally and building strategic partnerships.
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 (SOPs, 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.
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