Regulatory Affairs Specialist

hace 2 semanas

Alcobendas, Madrid, España Precision Medicine Group A tiempo completo
Regulatory Manager Job Description

Precision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the timely preparation and submission of high-quality regulatory documents to regulatory authorities and ethics committees.

Key Responsibilities:

  • Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, pediatric planning, and accelerated procedures.
  • Compile, coordinate, and review applications to regulatory authorities, including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications.
  • Develop and/or review documents intended for submission to regulatory authorities and/or ethics committees to ensure compliance with regulatory standards.
  • Serve as a representative of Global Regulatory Affairs at project team meetings with external and internal customers.
  • Work within a project team and lead projects for the region or globally as needed.
  • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs.
  • Maintain project plans, project trackers, and regulatory intelligence tools as it pertains to assigned responsibilities and keep Regulatory Leadership updated.
  • Assist in the development of Regulatory Affairs Specialists and other operational area staff as required.
  • Provide input into regulatory strategy and timeline development for new study opportunities.
  • Assist in establishing company standards to ensure the highest quality of submitted information.
  • Participate in maintaining and executing on corporate quality initiatives across business units within clinical solutions.
  • Stay up-to-date with laws, regulations, and guidelines governing drug development and approval.
  • Provide ICH GCP guidance, advice, and training to internal and external clients.
  • Serve as a representative of Global Regulatory Affairs at business development meetings.

Qualifications:

  • Bachelor's degree or equivalent experience in a scientific or healthcare discipline.
  • 5 years of regulatory experience required for the Manager level and 7 years of regulatory experience required for the Senior Manager Regulatory level.
  • Computer literacy (MS Office/Office 365).
  • Fluent in English.

Preferred Qualifications:

  • Graduate or postgraduate degree.
  • Possesses basic understanding of financial management.

Other Requirements:

  • Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions.
  • Informed knowledge of all aspects of the drug development process, including regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US), including submissions to regulatory authorities, including INDs/CTAs and amendments, scientific advice procedures, and post-approval submissions.
  • Ability to understand clinical and pre-clinical study results to help in its interpretation for regulatory positions and strategy.
  • Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied.
  • Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development.
  • Availability for domestic and international travel, including overnight stays.

Competencies:

  • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities.
  • Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture, and positive interactions with customers and teammates.
  • Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills.
  • Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
  • Motivates other members of the project team to meet timelines and project goals.
  • Flexible attitude with respect to work assignments and new learning.
  • Resolves project-related problems and prioritizes workload to meet deadlines with little support from management.
  • Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
  • Collects data of consistently high standard.
  • Communicates effectively in the English language both verbally and in written form.
  • Conducts formal presentations to a wide variety of audiences, including colleagues, investigative staff, and clients, with a high level of proficiency.

  • Regulatory Affairs Specialist

    hace 2 semanas

    Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

    Regulatory Manager Job DescriptionPrecision for Medicine is seeking a highly skilled Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and submissions to Regulatory Authorities and/or Ethics Committees.Key Responsibilities:Develop and implement regulatory strategies to ensure...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

    Regulatory Manager Job DescriptionPrecision for Medicine is seeking a highly skilled Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and submissions to Regulatory Authorities and/or Ethics Committees.Key Responsibilities:Develop and implement regulatory strategies to ensure...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

    Regulatory Manager Job DescriptionPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

    Regulatory Manager Job DescriptionPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric...

  • Regulatory Affairs Specialist

    hace 1 mes

    Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

    Regulatory ManagerPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a Regulatory Manager, you will play a critical role in ensuring the timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations.Key Responsibilities:Provide regulatory strategy and development...

  • Regulatory Affairs Specialist

    hace 1 mes

    Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

    Regulatory ManagerPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a Regulatory Manager, you will play a critical role in ensuring the timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations.Key Responsibilities:Provide regulatory strategy and development...

  • Regulatory Affairs Specialist

    hace 5 días

    Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

    Job Summary:Precision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a Regulatory Manager, you will be responsible for providing regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures.Key...

  • Regulatory Affairs Specialist

    hace 1 semana

    Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

    Regulatory Manager Job DescriptionPrecision Medicine Group is seeking a highly skilled Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for providing strategic guidance and support to ensure the timely preparation and submission of high-quality regulatory documents to regulatory authorities and...

  • Medical Device Regulatory Affairs Specialist

    hace 4 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Job Title: Medical Device Regulatory Affairs LeadWe are seeking a highly skilled Medical Device Regulatory Affairs Lead to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for overseeing key regulatory activities and providing strategic and tactical support on combination product portfolios.Key...

  • Medical Device Regulatory Affairs Specialist

    hace 4 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Job Title: Medical Device Regulatory Affairs LeadWe are seeking a highly skilled Medical Device Regulatory Affairs Lead to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for overseeing key regulatory activities and providing strategic and tactical support on combination product portfolios.Key...

  • Regulatory Affairs Expert

    hace 4 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Job Title: Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines.Key Responsibilities:Provide overall project leadership and ensure successful...

  • Regulatory Affairs Expert

    hace 4 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Job Title: Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines.Key Responsibilities:Provide overall project leadership and ensure successful...

  • Regulatory Affairs Expert

    hace 1 día

    Alcobendas, Madrid, España Parexel A tiempo completo

    Parexel's Regulatory Affairs TeamWe are seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines.About the RoleThe ideal candidate will possess strong regulatory affairs experience, project management skills, and...

  • Regulatory Affairs Expert

    hace 1 semana

    Alcobendas, Madrid, España Parexel A tiempo completo

    Parexel Seeks Regulatory Affairs ExpertAt Parexel, we're committed to delivering exceptional consulting services to our clients. We're seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines.Key Responsibilities:Provide...

  • Regulatory Affairs Expert

    hace 1 semana

    Alcobendas, Madrid, España Parexel A tiempo completo

    Parexel is seeking a highly qualified Regulatory Affairs Expert to join our team.Parexel, a leading Clinical Research Organization (CRO), is looking for a skilled CMC Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience, project management skills,...

  • Regulatory Affairs Project Lead

    hace 1 mes

    Alcobendas, Madrid, España Parexel A tiempo completo

    Senior Regulatory Affairs Consultant (Project Lead)We are seeking a highly experienced Senior Regulatory Affairs Consultant to lead internal projects on behalf of our clients. As a Senior Consultant, you will be responsible for providing a broad range of consulting services and working within project guidelines to identify, refine, and address client issues...

  • Regulatory Affairs Project Lead

    hace 1 mes

    Alcobendas, Madrid, España Parexel A tiempo completo

    Senior Regulatory Affairs Consultant (Project Lead)We are seeking a highly experienced Senior Regulatory Affairs Consultant to lead internal projects on behalf of our clients. As a Senior Consultant, you will be responsible for providing a broad range of consulting services and working within project guidelines to identify, refine, and address client issues...

  • Senior Regulatory Affairs Consultant

    hace 1 mes

    Alcobendas, Madrid, España Parexel A tiempo completo

    Job Title: Senior Regulatory Affairs ConsultantWe are seeking a highly skilled Senior Regulatory Affairs Consultant to join our team at Parexel. As a Senior Consultant, you will be responsible for leading internal projects on behalf of our clients, providing a broad range of consulting services, and working within project guidelines to identify, refine, and...

  • Senior Regulatory Affairs Consultant

    hace 1 mes

    Alcobendas, Madrid, España Parexel A tiempo completo

    Job Title: Senior Regulatory Affairs ConsultantWe are seeking a highly skilled Senior Regulatory Affairs Consultant to join our team at Parexel. As a Senior Consultant, you will be responsible for leading internal projects on behalf of our clients, providing a broad range of consulting services, and working within project guidelines to identify, refine, and...

  • Senior Regulatory Affairs Specialist

    hace 2 días

    Alcobendas, Madrid, España Parexel A tiempo completo

    Accelerating Time to Filing and ApprovalParexel is seeking an experienced Regulatory Affairs professional to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets. This is an exciting opportunity to play a crucial role in accelerating time to filing and approval in Global Country Initiative (GCI),...