Empleos actuales relacionados con Regulatory Affairs Director - Madrid, Madrid - Innovaderm Research
-
Regulatory Affairs Director
hace 1 mes
Madrid, Madrid, España Innovaderm Research A tiempo completoJob Title: Associate Director, Regulatory AffairsJob Summary:The Associate Director, Regulatory Affairs is a key member of our team, responsible for overseeing the Regulatory Affairs group in assigned regions. This role ensures that all regulatory activities are conducted according to Innovaderm's standard operating procedures, applicable regulations, and...
-
Regulatory Affairs Director
hace 1 mes
Madrid, Madrid, España Innovaderm Research A tiempo completoJob Title: Associate Director, Regulatory AffairsJob Summary:The Associate Director, Regulatory Affairs is a key member of our team, responsible for overseeing the Regulatory Affairs group in assigned regions. This role ensures that all regulatory activities are conducted according to Innovaderm's standard operating procedures, applicable regulations, and...
-
Senior Regulatory Affairs Director
hace 2 semanas
Madrid, Madrid, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs Medical Device Lifecycle ManagementAt Cpl Healthcare, we are seeking an experienced Associate Director, Regulatory Affairs Medical Device Lifecycle Management to join our Pharmaceutical team.This key role will be responsible for the strategic lifecycle management of our Medical Device portfolio, ensuring...
-
Regulatory Affairs Director
hace 4 semanas
Madrid, Madrid, España Innovaderm Research A tiempo completoJob Title: Associate Director, Regulatory AffairsJob Summary:The Associate Director, Regulatory Affairs is a key member of our team, responsible for overseeing the Regulatory Affairs group in assigned regions. This role ensures that all regulatory activities are conducted according to Innovaderm's standard operating procedures, applicable regulations, and...
-
Regulatory Affairs Director
hace 4 semanas
Madrid, Madrid, España Innovaderm Research A tiempo completoJob Title: Associate Director, Regulatory AffairsJob Summary:The Associate Director, Regulatory Affairs is a key member of our team, responsible for overseeing the Regulatory Affairs group in assigned regions. This role ensures that all regulatory activities are conducted according to Innovaderm's standard operating procedures, applicable regulations, and...
-
Regulatory Affairs Expert
hace 2 semanas
Madrid, Madrid, España Sobi Group A tiempo completoKey Responsibilities and Accountabilities:Global Regulatory LeadershipThe Global Regulatory Affairs Lead provides global regulatory leadership of assigned programs, developing global regulatory strategies, including risk assessment and mitigation strategies. This role chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s) and is the...
-
Regulatory Affairs Specialist
hace 3 semanas
Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completoRegulatory Affairs SpecialistAs a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our clinical trials with regulatory requirements. Your responsibilities will include providing regulatory guidance throughout the clinical development life cycle, compiling and coordinating applications to Regulatory Authorities, and...
-
Regulatory Affairs Specialist
hace 4 semanas
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 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 5 días
Madrid, Madrid, España Kenvue A tiempo completoRegulatory Affairs InternAt Kenvue, we are committed to delivering high-quality products that meet the highest standards of safety and efficacy. As a Regulatory Affairs Intern, you will play a critical role in ensuring compliance with regulatory requirements and maintaining our competitive edge in the market.Key Responsibilities:Regulatory Affairs:...
-
Regulatory Affairs Specialist
hace 1 mes
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 mes
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 4 semanas
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 4 semanas
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 Expert
hace 3 semanas
Madrid, Madrid, España Parexel A tiempo completoUnlock Your Potential in Regulatory AffairsWe are seeking a highly experienced Senior Regulatory Affairs Manager/Consultant to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for managing client relationships, developing regulatory strategies, and ensuring compliance with EU guidelines.Key...
-
Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Kenvue A tiempo completoWe are seeking a talented Regulatory Affairs Intern to join our team at Kenvue. As a Regulatory Affairs Intern, you will play a key role in ensuring the compliance of our products with regulatory requirements in Spain.Key Responsibilities:Coordinate and submit new drug applications, cosmetics, medical devices, food supplements, or similar products to...
-
Regulatory Affairs Specialist
hace 4 semanas
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...
-
Regulatory Affairs Specialist
hace 4 semanas
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...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Alk-Abelló AS A tiempo completoJob Title: Regulatory ProfessionalWe are seeking a highly skilled Regulatory Professional to join our team at Alk-Abelló A/S. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our pharmaceutical products.Key Responsibilities:Handling CMC documentation for products...
-
Regulatory Affairs Specialist
hace 4 semanas
Madrid, Madrid, España Alk-Abelló AS A tiempo completoJob Title: Regulatory ProfessionalWe are seeking a highly skilled Regulatory Professional to join our team at Alk-Abelló A/S. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our pharmaceutical products.Key Responsibilities:Handling CMC documentation for products...
Regulatory Affairs Director
hace 2 meses
Job Summary:
The Associate Director, Regulatory Affairs is a key member of our team, responsible for overseeing the Regulatory Affairs group in assigned regions. This role ensures that all regulatory activities are conducted according to Innovaderm's standard operating procedures, applicable regulations, and good clinical practices.
Key Responsibilities:- Leadership and Oversight: Provide leadership on regulatory activities that lead to global start-up of clinical trials, plan and assign work, oversee the performance of direct reports, and perform annual reviews.
- Regulatory Expertise: Serve as a subject matter expert in regulatory affairs within the department and to the organization, assisting with development of submission strategies.
- Project Management: Manage performance, establish clear objectives and performance indicators, conduct formal performance reviews, and develop direct reports.
- Team Development: Plan regional adequate resources, ensure adequate training, and oversee practices to ensure alignment of practices across the team.
- Client and Stakeholder Management: Serve as a senior point of contact for project teams, assist with sponsor interactions, and escalate issues to management as necessary.
- Quality and Process Improvement: Lead departmental quality and process improvement initiatives, continuously monitor, identify, and report quality issues, develop proactive solutions, and initiate action plans.
- Business Development: Participate in request for proposals and requests for information for new studies, outline regulatory strategies, and evaluate project budgets at the proposal stage.
About Innovaderm:
Innovaderm is a contract research organization (CRO) specialized in dermatology. We offer a stimulating work environment, attractive advancement opportunities, and a company benefits package. As a member of our team, you will have the opportunity to work with brilliant and driven colleagues, collaborate on innovative projects, and contribute to the growth and success of our organization.
Requirements:
- Education: Bachelor's degree (or equivalent) in life sciences or scientific discipline.
- Experience: At least 8 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, and/or CRO industry, including 3 years in a management role.
- Skills: Solid knowledge of review and approval processes of applicable regulatory Health Authorities, excellent communication and interpersonal skills, and ability to assess impact of evolving information and provide guidance.
