Director of Regulatory Affairs Stellenangebote

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Stellenangebote Director Of Regulatory Affairs Jobs bei Jobleads

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

Führungs-/ Leitungspositionen

MEHR

Associate Director Engineering- Device Technology (m/f/d) Job ID REQ- 10026381 Austria 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 [...] 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 vor 5 Tagen gefunden General Manager Commercial and Contracting

MEHR

General Manager Commercial and Contracting We are seeking an experienced and strategic General Manager Commercial and Contracting to oversee and drive the commercial performance of ADF Health Services (ADFHS) , encompassing ADF, Department of Veterans Affairs (DVA) , and Open Arms (OA) . In this pivotal role, you will lead and optimise the commercial outcomes across [...] be key in ensuring we deliver optimal outcomes for the ADFHS business. You will add value by: Develop and execute growth initiatives for the portfolio, maximising commercial outcomes and aligning with the company s broader strategy. Collaborate with the ADF Director to implement optimisation strategies across the ADF portfolio. Oversee the ADFHS Contract, Subcontractor Contracts, and agreements with Joint Health Command [...] process of existing contracts and the bidding for new government contracts, ensuring alignment with organizational goals and competitive positioning. Lead the development, monitoring, and management of performance frameworks for financial and operational contract performance. Ensure all contracts comply with legal, regulatory, and company standards, working closely with the Legal team. Monitor, report, and analyse contract adherence and performance, ensuring governance and [...]
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Job vor 6 Tagen gefunden

Medical Director, Metabolics

• Zürich Führungs-/ Leitungspositionen

MEHR

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead [...] Position Summary: ultra dedicated Your biggest challenges yield rare possibilities Ultragenyx is seeking a medical professional with the passion and creativity to develop new therapies for patients with rare and ultra- rare diseases. Reporting to the VP Head of Medical Affairs EMEA, this role will be a key contributor to shaping strategy and implementing the medical affairs plans for Metabolics. Furthermore, [...] This will include training as well as development of materials. Partner cross- functionally within medical affairs on assigned programs with all key stakeholders e. g. , Cluster medical leads and field teams, training, Market Access, molecular diagnostics, patient advocacy, commercial, regulatory, clinical development and other related departments. Exhibit leadership skills within and outside of the organization (including collaboration, mentoring, presentation skills [...]
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Job vor 8 Tagen gefunden Director Corporate Audit (m/f/d) • München, Bayern Führungs-/ Leitungspositionen

MEHR

Director Corporate Audit (m/f/d) Apply remote type Hybrid locations Munich time type Full time posted on Posted 2 Days Ago job requisition id JR100470 About us Bay Wa r. e. AG Holding in Munich, with an outstanding view over the Alps, unites about 400 people of all our core Corporate Functions under one roof. With comprehensive service offerings, we support our renewable energy business worldwide from [...]

Job vom 27.11.2024

Medical Director- EU (Switzerland)

Führungs-/ Leitungspositionen

MEHR

Department: Medical Affairs Summit Therapeutics (Summit) Mission To build a viable, long- lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal- friendly medicinal therapy intended to improve quality of life, increase potential duration of life, and [...] in first- line PD- L1 High, Metastatic NSCLC ( HARMONi- 7 ) Ivonescimab is an investigational therapy that is not approved by any regulatory authority other than China s National Medical Products Administration (NMPA) . Overview of Role: The Medical Director, Europe, is a highly motivated and experienced scientific expert specializing in Immuno- Oncology. Reporting to the Head of Global Medical [...]

Job vom 25.11.2024 Head of Trading Compliance (d/ f/m) • Karlsruhe, Baden- Württemberg Führungs-/ Leitungspositionen

MEHR

A wide range of Tasks We are looking for an experienced Compliance Manager for our Trading business unit. In this role, you will work [...] and optimize the existing compliance management system to ensure we meet all our local and international compliance requirements. You will actively contribute to the development of compliance structures specific or particularly relevant for Trading, for example compliance with competition law, regulatory reporting, and sanctions, and will coordinate the relevant Plan- Do- Check- Act cycles. Reporting to the Director of Risk, you will lead a team that will work with you to coordinate compliance work internally and externally: Development [...] to adapt to our changing business requirements. Monitor regulatory compliance in the area of algo trading. Monitor compliance with respect to regulatory reporting (MiFID, REMIT, MAR) and ESG reporting. Work with internal stakeholders, in particular Legal and Market Design Regulatory Affairs, to analyze and evaluate suspicious cases, new requirements and risks, and develop appropriate solutions. Perform compliance risk assessments and provide [...]
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Job vom 14.11.2024

Associate Director- (Senior) Patient Safety Physician (gn) : Oncology Baden- Württemberg, German. . .

Führungs-/ Leitungspositionen

MEHR

Associate 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 vom 08.11.2024 Associate Director Engineering- Device Technology (m/f/d) • Schaftenau, Tirol Führungs-/ Leitungspositionen

MEHR

Associate 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 26.10.2024

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

• München, Bayern Führungs-/ Leitungspositionen

MEHR

Our 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 25.10.2024 Director Medical Affairs- Hematology (f/m/d) Führungs-/ Leitungspositionen

MEHR

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Stellenangebote Director Of Regulatory Affairs Jobs bei StepStone

Job vom 30.11.2024 Otsuka Pharma GmbH

Director, Global CMC Regulatory Affairs (EU) (m/f/d)

• Frankfurt am Main Führungs-/ Leitungspositionen Beratungs-/ Consultingtätigkeiten

MEHR

Otsuka- people creating new products for better health worldwide. More than 47, 000 employees worldwide in the 196 companies of the Otsuka Pharmaceutical Group are committed to this. With creativity and a spirit of research, we develop innovative products to [...] 28 countries with a unique corporate culture that combines Japanese and Western values. An inspiring environment for people who are open to innovation and creativity and want to make a difference together For Otsuka Pharma GmbH in the department Global Regulatory Affairs we are looking for a full- time employee to start as soon as possible as Director, Global CMC Regulatory Affairs (EU) (m/f/d) Anticipate, develop and recommend strategies and contingency plans, provide guidance, determine regulatory and scientific/ [...]
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Stellenangebote Director Of Regulatory Affairs Jobs bei Neuvoo

Job vor 4 Tagen gefunden Jobleads Senior Medical Director Oncology Clinical Development- Solid Tumor • Bezirk Schaffhausen, Schaffhausen, Switzerland Führungs-/ Leitungspositionen

MEHR

Company Description Abb Vies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas immunology, oncology, neuroscience, and [...] Job Description Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Abb Vie s customers, markets, business operations, and emerging issues. Oversees project- related education of investigators, study site personnel, [...] development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. Acts as clinical lead and actively solicits opinion leader interactions related to the disease area (s) ; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross- functional perspectives [...]

Job vor 5 Tagen gefunden Jobleads Medical Director, Metabolics • Bezirk Zuerich, Zürich, Switzerland Führungs-/ Leitungspositionen

MEHR

Job vor 7 Tagen gefunden Jobleads P2429- Associate Medical Director Oncology • Lausanne District, Lausanne, Switzerland Führungs-/ Leitungspositionen

MEHR

Debiopharm is a privately- owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique development only business model, acting as a bridge [...] infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow. For our Clinical Development organization based at our Headquarters in Lausanne, we are looking for Associate Medical Director Oncology As an Associate Medical Director in Clinical Development, you will play a pivotal role in shaping the future of [...] functional teams to execute clinical studies and support the overall Clinical Development Plan. Design and implement study protocols, ensuring adherence to the highest standards of scientific rigor and ethical conduct. Foster strategic partnerships with key stakeholders including Pharmacovigilance, Clinical Operations, Regulatory Affairs, and Biostatistics to ensure seamless study execution. Provide insightful analysis and interpretation of clinical data, driving evidence- based decision- making [...]

Job vom 28.11.2024 Jobleads

Associate Medical Director Clinical Science

• Basel- Stadt, Basel, Switzerland Führungs-/ Leitungspositionen

MEHR

Associate Medical Director Clinical Science Full- time Sobi Location: United States Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100 of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100 of the qualifications. We [...] patients who are in need of life- saving treatments Role Function The Associate Director Clinical Science is responsible for Sobi s clinical development activities and serves as scientific and medical expert on matters relating to the assigned development program including regulatory and drug safety. Key Responsibilities Provide clinical, medical, and strategic input to clinical development plans, while adhering to the highest [...] Health Authority s questions to support e. g. , scientific advice, IND application, marketing authorization. Where applicable and assigned, provide scientific and medical expert support to other functions within Sobi on specific therapeutic area of expertise, including global safety, medical affairs activities such as advisory boards, scientific communications publications, and business development such as due diligence evaluations of external compounds and [...]

Job vom 23.10.2024 Jobleads Senior Director, Head of IAI Medical Affairs, Region Europe • Morges District, Morges, Switzerland Führungs-/ Leitungspositionen

MEHR

Overview: Summary This is a great position within a promising therapeutic area that includes innovative medicine in Inflammation and Autoimmunity (IAI) and more in particular in Dermatology. This is the accountable leadership position in Medical Affairs Region Europe for IAI. This person will lead the Medical Affairs IAI team in Regional Headquarters (HQ) have dotted line responsibility for the country medical affairs leads. As head of IAI Medical Affairs Region Europe, this person will lead the strategy all medical affairs activities. This person will lead and [...] as within company guidelines. Requirements MD/ PhD with 10+ years in academic, clinical, industry setting required. Dermatology/ Immunology experience required. Familiarity with GCP/ ICH/ FDA requirements as well as clinical trial design, biostatistics, medical writing, product safety, healthcare compliance and regulatory affairs. Strong interpersonal, verbal and written communication skills. Strong public speaking skills. Excellent leadership and management skills. Ability to influence [...]
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