Director of Regulatory Affairs Stellenangebote


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Jobbörse Stellenangebote Director Of Regulatory Affairs Jobs gefunden bei Jobbörse Jobleads

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Job vor 2 Tagen gefunden

Country Medical Director (Senior Director) for Germany and Switzerland

• München, Bayern Führungs-/ Leitungspositionen
MEHRCountry Medical Director (Senior Director) for Germany and Switzerland ViiV Healthcare is a global specialist HIV company dedicated to delivering innovative new options for the care and treatment of people living with HIV/ AIDS. As the Country Medical Director, you will play a pivotal role in shaping and driving [...] the medical teams to achieve the highest standards of medical and scientific excellence. A key focus of this role will be to define the unmet medical need of the long- acting HIV treatment and prevention modalities, while also overseeing patient affairs to enhance patient engagement and support. Key Responsibilities: Leadership and Strategy: Develop and implement the country medical strategy for Germany [...] a culture of excellence, collaboration, and continuous improvement Drive the long- acting market transformation of HIV treatment, ensuring that innovative long- acting therapies are effectively integrated into clinical practice Represent ViiV Healthcare in interactions with key stakeholders, including healthcare professionals, regulatory authorities, and patient advocacy groups Medical Affairs: Lead the planning and execution of medical activities, including advisory boards, symposia, and [...]
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Job vor 5 Tagen gefunden Country Medical Director (Senior Director) for Germany and Switzerland • München, Bayern Führungs-/ Leitungspositionen
MEHRSite Name: Munich- Office Posted Date: Nov 14 2024 Country Medical Director (Senior Director) for Germany and Switzerland The deadline for the job posting is the 28th of November in 2024 Overview: ViiV Healthcare is a global specialist HIV company dedicated to delivering innovative new options for the [...] the medical teams to achieve the highest standards of medical and scientific excellence. A key focus of this role will be to define the unmet medical need of the long- acting HIV treatment and prevention modalities, while also overseeing patient affairs to enhance patient engagement and support. Key Responsibilities: Leadership and Strategy: Develop and implement the country medical strategy for Germany [...] a culture of excellence, collaboration, and continuous improvement Drive the long- acting market transformation of HIV treatment, ensuring that innovative long- acting therapies are effectively integrated into clinical practice Represent ViiV Healthcare in interactions with key stakeholders, including healthcare professionals, regulatory authorities, and patient advocacy groups Medical Affairs: Lead the planning and execution of medical activities, including advisory boards, symposia, and [...]
Job vor 6 Tagen gefunden

Medical Director, Rheumatology

• Langen, Hessen Führungs-/ Leitungspositionen Work-Life-Balance
MEHRMedical Director, Rheumatology ICON plc is a world- leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Rheumatologist to join our diverse and dynamic team at ICON. As the Medical [...] execution of clinical research programs. What you will be doing Providing medical expertise and guidance to cross- functional teams on the design, implementation, and interpretation of clinical trials. Serving as the primary medical liaison with investigators, key opinion leaders, and regulatory authorities to ensure scientific integrity and compliance with regulatory requirements. Contributing to the development of clinical study protocols, investigator brochures, and other medical and scientific documents. Reviewing and analyzing clinical trial data to support decision- making and strategic planning. Collaborating with medical monitors, clinical operations, and regulatory affairs teams to ensure the safety and ethical conduct of clinical trials. Providing medical input and support for publications, presentations, and [...]
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Job vor 7 Tagen gefunden Associate Director- (Senior) Patient Safety Physician (gn) : Oncology Baden- Württemberg, German. . . Führungs-/ Leitungspositionen
MEHRAssociate Director- (Senior) Patient Safety Physician (gn) : Oncology Baden- Württemberg, Germany, or relocation to Germany (relocation assistance available) . #clientvacancy #director #pv oncology Together with a German member of INRALS (International Network of Recruitment Agencies in Life Sciences) , we are looking for an Associate Director Patient Safety Physician [...] database setup, continual safety monitoring, and addressing safety concerns. Engaging in cross- functional collaboration with departments such as Clinical Development and Global Patient Engagement to devise patient- centric benefit- risk evaluations for developmental compounds. Collaborating with Global Epidemiology and Medical Affairs to design safety- oriented post- authorization studies. Analyzing clinical trial safety data for incorporation into clinical trial reports and regulatory submissions. Providing medical- scientific insights into regulatory documents, including PSURs, DSURs, RMPs, and Clinical Overview Statements. Keeping senior management apprised [...]
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Job vor 13 Tagen gefunden

Associate Director Engineering- Device Technology (m/f/d)

• Schaftenau, Tirol Führungs-/ Leitungspositionen
MEHRAssociate Director Engineering- Device Technology (m/f/d) Job ID: REQ- 10026381 Summary LOCATION: Schaftenau, TYPE: Hybrid Working, #LI Hybrid Are you looking for a challenging and rewarding career in Combination Product Development with a brand new device? Do you want to be part of a team of talented and passionate engineers and scientists responsible for the development of parenteral combination products to ensure that [...] as well as LCM of commercial products. Write key design history file documents: design input requirements, global component specifications, and design verification documents. Ensure device design development is delivered to a high quality following the design control process and applicable regulatory framework. Ensure components are delivered and controlled to the required quality for clinical trials and commercial production. Support Regulatory Affairs to prepare medical device/ combination product pre- registration documents and provide input to answer health authority questions. Support internal external [...]
Job vom 05.11.2024 Associate Director Engineering- Device Technology (m/f/d) • Schaftenau, Tirol Führungs-/ Leitungspositionen
MEHRJob Description Summary LOCATION: Schaftenau, TYPE: Hybrid Working, #LI Hybrid Are you looking for a challenging and rewarding career in Combination Product Development with a brand new device? Do you want to be part of a team of talented and passionate engineers and scientists who are responsible for the development of parenteral combination products to ensure that our delivery systems fulfill the highest customer expectations? If yes, then this is the opportunity for you The Device Technology Solution Center is seeking an Associate Director Engineering within the Global Device and Packaging Development (GDPD) department in Schaftenau, Austria. Job Description Key Responsibilities: Lead technical development [...] as well as LCM of commercial products. Write key design history file documents: design input requirements, global component specifications and design verification documents. Ensure device design development is delivered to a high quality following the design control process and applicable regulatory framework. Ensure components are delivered and controlled to the required quality for clinical trials and commercial production. Support Regulatory Affairs to prepare medical device/ combination product pre- registration documents and provides input to answer health authority questions. Support internal external [...]
Job vom 27.10.2024

EMEA Regulatory Affairs- Executive Director/ Vice President (all genders)

• Frankfurt, Hesse Führungs-/ Leitungspositionen
MEHR[...] with EU based regulators including but not limited to the ECB, ESMA, EBA, and the European Systemic Risk Board. The position will be based in Frankfurt. The role would require regular travels, primarily to London and EU countries (approximately 25 of the time) . As a Executive Director/ Vice President within our EMEA Regulatory Affairs team, you will support regulatory policy engagement in the region. You will act as a member of the EMEA Regulatory [...]
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Job vom 25.10.2024 Director Medical Affairs- Hematology (f/m/d) Führungs-/ Leitungspositionen
MEHROur team of expert medical affairs physicians and scientists at Regeneron bridge the gap between our innovative medicines and the scientific and healthcare community. As the Director Medical Affairs Hematology, you will represent Regeneron in Medical Affairs and Clinical Development providing scientific and medical leadership for our [...] a multifunctional, matrix organization, aligning with Global and US teams to ensure that medical and clinical activities in Germany are in sync with global strategies and goals. You will collaborate with internal colleagues across Medical Affairs, Clinical Sciences, Operations, and Regulatory, and provide guidance to Commercial teams. As the key medical resource for Hematology in Germany, you will be instrumental in [...]
Job vom 24.10.2024

Director Medical Affairs- Hematology (f/m/d)

• München, Bayern Führungs-/ Leitungspositionen
MEHROur team of expert medical affairs physicians and scientists at Regeneron bridge the gap between our innovative medicines and the scientific and healthcare community. As the Director Medical Affairs Hematology, you will represent Regeneron in Medical Affairs and Clinical Development providing scientific and medical leadership for our [...] a multifunctional, matrix organization, aligning with Global and US teams to ensure that medical and clinical activities in Germany are in sync with global strategies and goals. You will collaborate with internal colleagues across Medical Affairs, Clinical Sciences, Operations, and Regulatory, and provide guidance to Commercial teams. As the key medical resource for Hematology in Germany, you will be instrumental in [...]
Job vom 22.10.2024 Medical Director, Rheumatology • Zürich Führungs-/ Leitungspositionen Work-Life-Balance
MEHRMedical Director, Rheumatology ICON plc is a world- leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Rheumatologist to join our diverse and dynamic team at ICON. As the Medical [...] execution of clinical research programs. What you will be doing Providing medical expertise and guidance to cross- functional teams on the design, implementation, and interpretation of clinical trials. Serving as the primary medical liaison with investigators, key opinion leaders, and regulatory authorities to ensure scientific integrity and compliance with regulatory requirements. Contributing to the development of clinical study protocols, investigator brochures, and other medical and scientific documents. Reviewing and analyzing clinical trial data to support decision- making and strategic planning. Collaborating with medical monitors, clinical operations, and regulatory affairs teams to ensure the safety and ethical conduct of clinical trials. Providing medical input and support for publications, presentations, and [...]
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Job vom 02.11.2024 Pharmiweb

Director Clinical Development- Neurology

• Geneva, CH Führungs-/ Leitungspositionen
MEHRDirector, Clinical Development (Neurology) Job Summary: We are seeking a highly motivated and experienced Director of Clinical Development with a specialization in Neurology to lead and drive our clinical development programs. The Director will play a [...] of Neurology therapies, managing clinical trials, and contributing to the strategic development of our Neurology portfolio. Key Responsibilities: Clinical Strategy : Develop and implement the clinical development strategy for our Neurology programs, including phase I- III trials, to ensure successful regulatory submissions and commercialization. Clinical Trial Design : Lead the design of clinical trials, including protocol development, selection of endpoints, and determination of appropriate patient populations. Regulatory Affairs : Collaborate with regulatory affairs to ensure compliance with regulatory requirements and provide guidance on clinical trial applications and approvals. [...]
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