Descrição da vaga
Tecnimede Group
Portugal, Sintra
Regulatory Affairs Specialist (M/F) em Sintra, Portugal is listed on Jobeax. Browse 30,000+ vacancies available.
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 datewith 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 workindependently 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."
Vagas semelhantes
Tecnimede Group
... 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 ...
Portugal, Sintra
Ascenza Agro
Assists and advises project teams on regulatory requirements for clinical studies, performs compliance assessments, handles submissions to regulatory bodies, and manages study documentation in Europe.
Portugal, Lisboa
Gentek.ai
Gentek builds agentic AI for regulated financial markets. Our platforms help banks and asset managers automate regulatory reporting under EMIR, SFTR, MiFIR and beyond. We're opening a Lisbon operations hub, and this is a founding hire for that team. What we are looking for We are looking for candidates who are excited to ...
Portugal, Lisboa
Gentek.ai
Gentek builds agentic AI for regulated financial markets. Our platforms help banks and asset managers automate regulatory reporting under EMIR, SFTR, MiFIR and beyond. We're opening a Lisbon operations hub, and this is a founding hire for that team. What we are looking for We are looking for candidates who are excited to ...
Portugal, Lisboa
€82,500 por año
... Takeda’s reputation. - Support new product launches, pipeline assessments, and potential in-licensing opportunities. - Manage and develop Market Access, Public Affairs, and Portfolio Partnership teams. - Ensure compliance with legal, ethical, regulatory, and Takeda requirements. - Monitor budgets, resource allocation, operational ...
Portugal, Lisboa
... congress-related activities. - Learn how medical information requests are managed and supported. - Collaborate with colleagues across Clinical Development, Regulatory Affairs, Market Access, Pharmacovigilance and Commercial functions to better understand the pharmaceutical environment. - Develop knowledge of Immunology and ...
Portugal, Lisboa
Tecnimede Group
... 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 ...
Portugal, Sintra
Tecnimede Group
... 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 ...
Portugal, Sintra
13k - 18900 / month
... compliance or financial crime risks Nice to have - Experience in UK FCA (FCA Handbook), Bank of England/PRA (PRA Handbook), EBA, ECB, and/or Bank of Lithuania regulatory requirements and recommendations - Regulatory experience in insurance (ICOBS), crypto-assets regulatory change (MICA), investment protections (MIFID), financial ...
Portugal, Évora
13k - 18900 / month
... compliance or financial crime risks Nice to have - Experience in UK FCA (FCA Handbook), Bank of England/PRA (PRA Handbook), EBA, ECB, and/or Bank of Lithuania regulatory requirements and recommendations - Regulatory experience in insurance (ICOBS), crypto-assets regulatory change (MICA), investment protections (MIFID), financial ...
Portugal, Beja
13k - 18900 / month
... compliance or financial crime risks Nice to have - Experience in UK FCA (FCA Handbook), Bank of England/PRA (PRA Handbook), EBA, ECB, and/or Bank of Lithuania regulatory requirements and recommendations - Regulatory experience in insurance (ICOBS), crypto-assets regulatory change (MICA), investment protections (MIFID), financial ...
Portugal, Portalegre
13k - 18900 / month
... compliance or financial crime risks Nice to have - Experience in UK FCA (FCA Handbook), Bank of England/PRA (PRA Handbook), EBA, ECB, and/or Bank of Lithuania regulatory requirements and recommendations - Regulatory experience in insurance (ICOBS), crypto-assets regulatory change (MICA), investment protections (MIFID), financial ...
Portugal, Funchal
13k - 18900 / month
... compliance or financial crime risks Nice to have - Experience in UK FCA (FCA Handbook), Bank of England/PRA (PRA Handbook), EBA, ECB, and/or Bank of Lithuania regulatory requirements and recommendations - Regulatory experience in insurance (ICOBS), crypto-assets regulatory change (MICA), investment protections (MIFID), financial ...
Portugal, Setúbal
€65200 EUR - €89650 EUR
... follow-up Translate strategy into an integrated omnichannel tactical plan and lead its execution, tracking impact and adjusting course Partner with Medical Affairs, Market Access and Corporate Affairs to build the clinical and value narrative with healthcare professionals, hospital pharmacy, procurement bodies and patient ...
Portugal, Caparica
Make individual mobility more enjoyable and sustainable by advancing technology and people – As one of the top 100 automotive suppliers worldwide, Webasto actively shapes the transformation of the industry through expertise and forward-thinking solutions.
Portugal, Lisboa
13k
... products, redefining success, and turning the complexity of a chaotic world into the simplicity of a beautiful solution. About the role Our Compliance team blends regulatory expertise with data-driven thinking to make sure our products meet legal and policy requirements and deliver real value to customers. In a fast-moving, digital ...
Portugal, Évora
13k
... products, redefining success, and turning the complexity of a chaotic world into the simplicity of a beautiful solution. About the role Our Compliance team blends regulatory expertise with data-driven thinking to make sure our products meet legal and policy requirements and deliver real value to customers. In a fast-moving, digital ...
Portugal, Santarém
13k
... products, redefining success, and turning the complexity of a chaotic world into the simplicity of a beautiful solution. About the role Our Compliance team blends regulatory expertise with data-driven thinking to make sure our products meet legal and policy requirements and deliver real value to customers. In a fast-moving, digital ...
Portugal, Porto
13k - 18900 / month
... compliance or financial crime risks Nice to have - Experience in UK FCA (FCA Handbook), Bank of England/PRA (PRA Handbook), EBA, ECB, and/or Bank of Lithuania regulatory requirements and recommendations - Regulatory experience in insurance (ICOBS), crypto-assets regulatory change (MICA), investment protections (MIFID), financial ...
Portugal, Vila Real