Regulatory Affairs Specialist
hace 1 día
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at PharmaLex. As a key member of our regulatory affairs team, you will be responsible for managing the creation and maintenance of labelling and regulatory submissions for innovator drugs on a global level.
Key Responsibilities- Participate in the preparation, revision, and compilation of informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in the EU and non-EU markets.
- Manage the creation and maintenance of CCDS/CCSI/RSI, as applicable, in collaboration with relevant departments and expert functions.
- Ensure communication to internal and external stakeholders regarding new and updated CCDSs.
- Escalate deviation and compliance issues to labelling governance bodies as necessary.
- Provide regulatory expertise to regulatory programs and projects, as well as to clients.
- General guidance and consultancy of PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities.
- Create, revise, edit, and maintain regulatory documentation.
- Professional interaction with clients and Health Authorities.
- Coordinate project teams with internal and external staff and Regulatory Alliance Partners on a worldwide level.
- Participate in strategic regulatory issues, including the definition of suitable methods of resolution.
- Provide technical support to business development with a focus on Labelling activities and adjacent areas on EU and global levels.
- Fluent business English or English as mother tongue.
- Skills in another EU language.
- Completed degree in pharmacy, medicine, or other life sciences or a bachelor's degree in science, engineering, or mathematical domain.
- Professional experience in regulatory affairs with a profound track record in labelling activities for innovator drugs on a global level.
- Experience in handling marketing authorizations and their lifecycle management.
- Sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region.
- Affinity for databases, labelling software tools, and project management software.
- Team player, communicative, conscientious, accurate, and responsible.
- Confident with MS Excel and MS Word as well as databases and document management systems.
-
Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Zentiva Group, a.s. A tiempo completoJob Title: Regulatory Affairs SpecialistAt Zentiva Group, a.s., we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing the Regulatory Affairs agenda at the country level, ensuring compliance with national and European regulations.Key...
-
Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Zentiva Group, a.s. A tiempo completoJob Title: Regulatory Affairs SpecialistAt Zentiva Group, a.s., we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing the Regulatory Affairs agenda at the country level, ensuring compliance with national and European regulations.Key...
-
Regulatory Affairs Specialist
hace 3 días
Madrid, Madrid, España Zentiva Group, A.S. A tiempo completoJob Title: Regulatory Affairs SpecialistJoin Zentiva Group, A.S. as a Regulatory Affairs Specialist and take on a challenging role that requires a deep understanding of regulatory requirements and a proactive approach to ensuring compliance.Key Responsibilities:Manage the Regulatory Affairs agenda at country level, ensuring that all regulatory submissions...
-
Regulatory Affairs Specialist
hace 3 días
Madrid, Madrid, España Zentiva Group, A.S. A tiempo completoJob Title: Regulatory Affairs SpecialistJoin Zentiva Group, A.S. as a Regulatory Affairs Specialist and take on a challenging role that requires a deep understanding of regulatory requirements and a proactive approach to ensuring compliance.Key Responsibilities:Manage the Regulatory Affairs agenda at country level, ensuring that all regulatory submissions...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Zentiva Group, a.s. A tiempo completoJob Title: Regulatory Affairs SpecialistZentiva Group, a.s. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing the Regulatory Affairs agenda at country level within Zentiva.Key Responsibilities:Provide an efficient and proactive Regulatory...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Zentiva Group, a.s. A tiempo completoJob Title: Regulatory Affairs SpecialistZentiva Group, a.s. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing the Regulatory Affairs agenda at country level within Zentiva.Key Responsibilities:Provide an efficient and proactive Regulatory...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Reconocida empresa A tiempo completoRegulatory Affairs SpecialistReconocida empresa is seeking a highly skilled Regulatory Affairs Specialist to join our team in Singapore. As a key member of our Regulatory Affairs team, you will be responsible for preparing life cycle management submissions to the Health Authority.Key Responsibilities:Receive and assess CLCN and CMC variations from the AP RMC...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Reconocida empresa A tiempo completoRegulatory Affairs SpecialistReconocida empresa is seeking a highly skilled Regulatory Affairs Specialist to join our team in Singapore. As a key member of our Regulatory Affairs team, you will be responsible for preparing life cycle management submissions to the Health Authority.Key Responsibilities:Receive and assess CLCN and CMC variations from the AP RMC...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Eurofragance, S.L. A tiempo completo{"h1": "Join Eurofragance as a Regulatory Affairs Junior Specialist", "p": "At Eurofragance, we are passionate about creating a world of fragrances and smells. As a Regulatory Affairs Junior Specialist, you will be part of our exciting journey, working with top professionals in a global and multicultural environment.Our company is committed to creating an...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Eurofragance, S.L. A tiempo completo{"h1": "Join Eurofragance as a Regulatory Affairs Junior Specialist", "p": "At Eurofragance, we are passionate about creating a world of fragrances and smells. As a Regulatory Affairs Junior Specialist, you will be part of our exciting journey, working with top professionals in a global and multicultural environment.Our company is committed to creating an...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid Centro, Madrid, España Zentiva Group, a.s. A tiempo completoRegulatory Affairs SpecialistAt Zentiva Group, a.s., we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing the regulatory agenda at the country level, ensuring compliance with national and European regulations, and supporting the...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid Centro, Madrid, España Zentiva Group, a.s. A tiempo completoRegulatory Affairs SpecialistAt Zentiva Group, a.s., we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing the regulatory agenda at the country level, ensuring compliance with national and European regulations, and supporting the...
-
Regulatory Affairs Specialist
hace 3 días
Madrid, Madrid, España Straumann A tiempo completoAbout StraumannStraumann is a global leader in implant and restorative dentistry and oral tissue regeneration. Our company has a proud history of pioneering innovations and advancing dental regeneration, restoration, and replacement. We partner with passionate individuals who share our vision and values.About the RoleWe are seeking a highly skilled...
-
Regulatory Affairs Specialist
hace 3 días
Madrid, Madrid, España Straumann A tiempo completoAbout StraumannStraumann is a global leader in implant and restorative dentistry and oral tissue regeneration. Our company has a proud history of pioneering innovations and advancing dental regeneration, restoration, and replacement. We partner with passionate individuals who share our vision and values.About the RoleWe are seeking a highly skilled...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Eurofragance, S.L. A tiempo completo{"h1": "Join Eurofragance as a Regulatory Affairs Junior Specialist", "p": "At Eurofragance, we are passionate about creating a world of fragrances and smells. As a Regulatory Affairs Junior Specialist, you will be part of our exciting journey, working with top professionals in a global and multicultural environment.Our company is committed to creating an...
-
Regulatory Affairs Specialist
hace 1 mes
Madrid Centro, Madrid, España Elanco A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Elanco. As a key member of our regulatory team, you will play a critical role in ensuring the successful development and approval of our animal health products.Key ResponsibilitiesDevelop and Implement Regulatory StrategiesDevelop and implement global regulatory...
-
Regulatory Affairs Specialist
hace 1 mes
Madrid Centro, Madrid, España Elanco A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Elanco. As a key member of our regulatory team, you will play a critical role in ensuring the successful development and approval of our animal health products.Key ResponsibilitiesDevelop and Implement Regulatory StrategiesDevelop and implement global regulatory...
-
Regulatory Affairs Specialist
hace 3 días
Madrid, Madrid, España Ramboll Group AS A tiempo completoJoin Our Team as a Regulatory Affairs ConsultantWe are seeking a highly skilled Regulatory Affairs Consultant to join our team in Barcelona. As a key member of our Health Sciences service line, you will play a crucial role in supporting our clients in bringing products to market while ensuring compliance with European regulations.About the RoleAs a...
-
Regulatory Affairs Specialist
hace 3 días
Madrid, Madrid, España Ramboll Group AS A tiempo completoJoin Our Team as a Regulatory Affairs ConsultantWe are seeking a highly skilled Regulatory Affairs Consultant to join our team in Barcelona. As a key member of our Health Sciences service line, you will play a crucial role in supporting our clients in bringing products to market while ensuring compliance with European regulations.About the RoleAs a...
-
Regulatory Affairs Specialist
hace 3 días
Madrid, Madrid, España Ramboll Group AS A tiempo completoUnlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Consultant to join our international team at Ramboll Group A/S. As a key member of our Health Sciences service line, you will play a crucial role in supporting clients and colleagues on product regulatory compliance and stewardship in Spain.Key...
