Senior Regulatory Affairs Manager

hace 4 semanas


Madrid, Madrid, España Innovaderm Research A tiempo completo

Job Summary

The Senior Regulatory Affairs Manager will oversee the Regulatory Affairs group in assigned regions, ensuring services are conducted according to Innovaderm's standard operating procedures, applicable regulations, and good clinical practices. This role requires leadership on regulatory activities, planning, and assigning work, overseeing direct reports, and performing annual reviews.

Key Responsibilities

  • Provide leadership on regulatory activities, including global start-up of clinical trials, planning, and assigning work.
  • Oversee the performance of direct reports, including annual reviews, addressing employee relation issues, and escalating concerns.
  • Ensure quality deliverables on time, within budget, and in compliance with SOPs, industry standards, regulations, and study-specific requirements.
  • Manage performance, establish clear objectives, and conduct formal performance reviews and talent conversation meetings.
  • Plan regional resources, forecast project needs, and oversee recruitment efforts to ensure adequate resources.
  • Ensure adequate regional training and oversee practices to ensure alignment across the team.
  • Serve as a subject matter expert in regulatory affairs, assist with submission strategies, and communicate project risks to management.
  • Support strategic business expansion activities, including new offerings and geographical regions.
  • Review documents and submissions, ensure complete and timely responses to Health Authorities, and perform regulatory project tasks as needed.
  • Lead departmental quality and process improvement initiatives, monitor quality issues, and develop proactive solutions.
  • Participate in request for proposals and requests for information, outline regulatory strategies, and evaluate project budgets.
  • Ensure adequate monitoring of out-of-scope work, accurate forecasting, and recognition of departmental project revenue.
  • Oversee implementation of systems related to departmental activities, including change management, documentation of procedures, and training.
  • Oversee vendors and subcontractors, ensuring high-quality standards before submission.
  • Write, review, and update related SOPs, tools, and working instructions.
  • Ensure centralization of global changing regulatory requirements and maintenance of regulatory intelligence databases.
  • Point of contact for client audits, regulatory agency inspections, and serious breach committees.

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 Senior Regulatory Affairs Manager, you will be eligible for a flexible work schedule, permanent full-time position, and ongoing learning and development.



  • Madrid, Madrid, España TRIUM Clinical Consulting NV A tiempo completo

    About the RoleWe are seeking a highly experienced Senior Regulatory Affairs Officer to join our team at QbD Group in Spain. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with pharmaceutical legislation and regulations.With a strong background in regulatory affairs, you will have expertise in ICH...


  • Madrid, Madrid, España Qiagen A tiempo completo

    About the Role:The Regulatory Affairs team at QIAGEN is seeking a qualified professional to take on a management role, alongside a Senior Manager. The ideal candidate will have experience in a regulated industry, with participation in Regulatory Affairs activities preparing FDA submissions and EU Technical Documentation.Key Responsibilities:Regulatory...


  • Madrid, Madrid, España Oatly A tiempo completo

    Oatly, the original oatmilk company, is expanding its presence in North America and seeks a highly skilled Regulatory Affairs Manager to join our team. As the leader of our US-based regulatory affairs function, you will provide expert guidance on food law and compliance matters.About the Role:This role involves leading the Oatly North America Regulatory...

  • Regulatory Affairs Expert

    hace 4 semanas


    Madrid, Madrid, España Parexel A tiempo completo

    Unlock 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...


  • Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    About the Role:This position is responsible for providing regulatory guidance throughout the clinical development life cycle, compiling and reviewing applications to Regulatory Authorities, and developing documents intended for submission to ensure compliance with regulatory standards.Key Responsibilities:Provide regulatory strategy and development guidance...


  • Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory Manager Job DescriptionThe Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable...


  • Madrid, Madrid, España Johnson And Johnson A tiempo completo

    Regulatory Affairs SpecialistJohnson and Johnson is seeking a skilled Regulatory Affairs Specialist to join our team in Madrid. This role offers a hybrid working model and is an exciting opportunity to contribute to our company's mission to build a world where complex diseases are prevented, treated, and cured.Key ResponsibilitiesSupport the growth of our...

  • Regulatory Affairs Expert

    hace 3 semanas


    Madrid, Madrid, España Sobi Group A tiempo completo

    Key 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...


  • Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory Manager Job DescriptionThe Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable...


  • Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory Manager Job DescriptionThe Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures. This role ensures timely preparation of well-organized, quality regulatory submissions in compliance with...


  • Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory Manager Job DescriptionWe are seeking a highly skilled Regulatory Manager to join our team at Precision for Medicine (CRO). The successful candidate will provide regulatory strategy and development guidance for optimal conduct of clinical trials, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with...


  • Madrid, Madrid, España Mcr International A tiempo completo

    Job Summary:Mcr International is seeking a highly skilled Senior Quality Assurance and Regulatory Affairs Manager to join our team. As a key member of our Quality Assurance and Regulatory Affairs department, you will be responsible for ensuring the company's compliance with regulatory requirements and maintaining a robust quality management system.Key...


  • Madrid, Madrid, España Cpl Healthcare A tiempo completo

    Job 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...


  • Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory ManagerThe Regulatory Manager plays a critical role in ensuring the compliance of clinical trials with applicable regulations. This includes providing regulatory strategy and development guidance, coordinating and preparing regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, and maintaining a current knowledge...


  • Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory 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...


  • Madrid, Madrid, España Kenvue A tiempo completo

    Regulatory 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:...


  • Madrid, Madrid, España Mcr International A tiempo completo

    Quality Assurance and Regulatory Affairs ManagerMADRIDQuality Assurance- Requirements:As a Quality Assurance and Regulatory Affairs Manager at Mcr International, you will participate in the implementation of a total quality culture in the company, ensuring full company compliance with MDR, ISO 13485, and 9001 requirements, and internal quality manuals,...


  • Madrid, Madrid, España Free Now A tiempo completo

    About This RoleWe are seeking an experienced public affairs and communications professional to join our team as a Senior Public Affairs And Communications Manager. As a key member of our central Public Affairs and Corporate Communications team, you will play a vital role in shaping our regulatory, public affairs engagement strategy, media relations,...


  • Madrid, Madrid, España Kenvue A tiempo completo

    We 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...


  • Madrid, Madrid, España Ventos A tiempo completo

    We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ventós Group. As a key member of our international company, you will be responsible for maintaining our product database, collaborating in the homologation of new products and suppliers, and preparing technical documentation for our products.As a Regulatory Affairs Specialist,...