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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 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 (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."
Seniority level
- Seniority level
Mid-Senior level
Employment type
- Employment type
Full-time
Job function
- Job function
Project Management and Production
- Industries
Pharmaceutical Manufacturing
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