Regulatory Affairs Specialist
Há 5 dias
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."
-
Sintra, Lisboa, Portugal Tecnimede Group Tempo inteiroTecnimede 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...
-
Pharmaceutical Quality Assurance Professional
Há 24 horas
Sintra, Lisboa, Portugal Tecnimede Group Tempo inteiroAbout UsTecnimede Group is a multinational company with over 40 years of experience in the drug product life cycle, encompassing development, production, promotion, and marketing. Our mission is to improve and preserve human life and health.With a presence in six countries, we export to over 100 nations worldwide. Our focus lies in expanding internationally...
-
Specialist Product Support
2 semanas atrás
Sintra, Lisboa, Portugal Phiture Tempo inteiroAbout UsLinData is an award-winning software solutions company. We believe finance matters to our society as much as energy to life and fueling financial transformation is vital for development and leadership.We humanize technology:Our team of passionate experts provides investment management and credit communities with innovative, user-friendly products...
-
Regulatory Affairs Specialist
4 semanas atrás
Sintra, Portugal Tecnimede Group Tempo inteiroTecnimede 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,...
-
Regulatory Affairs Specialist
Há 2 dias
Sintra, Portugal Tecnimede Group Tempo inteiroTecnimede 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,...
-
Field Value Access Partner
Há 20 horas
Sintra, Portugal Novartis Tempo inteiro**Summary**: - Leads the implementation of a sustainable Patient Access strategy at a local (CPO) level. Collects and analyze data to generate insights for Patient Access submissions that jointly create value for customers, patients and Novartis. **About the Role**: **Major accountabilities**: **Key performance indicators**: - Achievement of Novartis...
-
Sintra, Portugal Tecnimede Group Tempo inteiroTecnimede 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...
-
Sintra, Portugal Tecnimede Group Tempo inteiroTecnimede 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...
