Regulatory Procedural Management and Clinical Trial

vor 7 Monaten

Munich, Deutschland Daiichi Sankyo Europe Vollzeit

With emphasis on product development and regulatory life cycle management in Europe and AMELA (Australia, Middle East, Eastern Europe, Latin America, Africa) this Senior Director position will provide regulatory leadership, guidance, project management and procedural focused strategy and support to assigned projects in a manner that is scientifically sound, commercially viable and in accordance with regulatory standards.
Represent RA and/or Daiichi Sankyo Europe in internal and external interactions (e.g. project and working teams, affiliates, license partners, authorities, industry associations) pertinent to regulatory procedural and project management. Lead or support projects to enhance the functionality and improve procedural processes of the organization and/or to adapt to a regulatory environment (“non-project projects”).

**Roles & Responsibilities**:
For assigned regulatory projects and “non-projects support” and in close collaboration with the global regulatory team and other functions:

- Lead the Regulatory Procedural & Project Management team in the EU & AMELA serving as a link between Regulatory Strategists, and other disciplines inside RA (e.g. Labelling, RegOps, Affiliates, CT office) and in R&D and in the business units
- Represent EU & AMELA Regulatory Procedure & Management in global regulatory and development teams and provide regulatory procedural guidance and operational strategy for assigned projects
- Plan, lead and manage assigned regulatory submissions during development and life cycle management, in alignment with Regulatory Strategists, to European and other assigned non-EU authorities. Determine required documents, coordinate the document preparation and project manage the planning and tracking for project and submission delivery timelines.
- Act as regulatory contact person for authorities for all procedural aspects and support internal communications on regulatory status for the assigned assets. Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives. Communicate important changes and trends within RA and other functions when relevant. Design and revise SOPs and SOIs if required.
- Lead assigned non-project tasks designed to enhance the functionality and processes of RA.
- Mentor/instruct and provide guidance to internal and external (in-)direct reports including members of the consultants and vendors. Plan, assign and direct work; manage competing priorities as appropriate.

**Education & Professional Experience**:

- Degree (Bachelor, Master, State Examination, Diploma) in pharmacy, medicine, life or natural science; PhD preferred
- Post-doctorate or professional experience in pre-clinical research or clinical development, a TOPRA diploma or Master Degree in Regulatory Affairs or further pharmaceutical specialization (e.g. “Fachapotheker für Arzneimittelinformation”) is a plus
- Deep knowledge of Global and European laws, regulations, guidelines in EU, US and Japan and other requirements for human medicinal product marketing authorization and maintenance is essential. Working knowledge of other evolving landscapes such as China.
- Experience of working in a global and European regulatory environment and interacting with regulatory authorities
- Excellent interpersonal leadership and communication skills. Ability to communicate and work across functions effectively in a multinational organization to accomplish results. Be “detailed-oriented” with a good oversight, well organized and self-motivated. Proven ability to plan, coordinate and lead activities simultaneously on multiple projects. High ethical behaviour.
- Foster effective, positive interactions with regulatory agencies, and corporate partners, and ability to lead and influence project teams, committees, etc. to attain group goals
- Computer proficiency (e. g. MS office, document management systems, databases) and excellent written and verbal communication skills in English. German and a third language preferred.

**Why work with us?**:

  • Clinical Trial Coordinator

    vor 7 Monaten

    Munich, Deutschland MSD Vollzeit

    **Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.** Under the oversight of the line-manager, this role is responsible for...

  • Transparency Specialist

    vor 7 Monaten

    Munich, Deutschland Staburo GmbH Vollzeit

    **Your responsibilities will include**: - All posting activities for drug, device, and biologic clinical trials - Authoring of protocol registrations and results postings for submission to local and global regulatory agencies - Maintenance of international clinical trial registry and results records on public databases including status tracking and...

  • Transparency Specialist

    vor 7 Monaten

    Munich, Deutschland Staburo GmbH Vollzeit

    **Your responsibilities will include**: - All posting activities for drug, device, and biologic clinical trials - Authoring of protocol registrations and results postings for submission to local and global regulatory agencies - Maintenance of international clinical trial registry and results records on public databases including status tracking and...

  • Clinical Trial Trainee

    vor 1 Woche

    Munich, Deutschland Linical Europe Vollzeit

    **Linical Co., Ltd. (‘Linical’**) **is a premier global CRO headquartered in Osaka, Japan.** Linical is listed in the prime segment of the Tokyo Stock exchange and dedicated to serve its clients as a true partner in development. With approximately 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and...

  • Global Clinical Trials Coordinator

    vor 1 Woche

    Munich, Bayern, Deutschland Pharmiweb Vollzeit

    Company Overview">We are Medpace, a full-service clinical contract research organisation (CRO). Our mission is to accelerate the global development of safe and effective medical therapeutics through our scientific and disciplined approach.We leverage local regulatory and therapeutic expertise across all major areas, including oncology, cardiology, metabolic...

  • Clinical Trial Leader

    Vor 6 Tagen

    Munich, Deutschland Boehringer Ingelheim Vollzeit

    Clinical Trial Leader (m/w/d)-228769 **OUR COMPANY**: At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about...

  • Regulatory Associate

    vor 2 Wochen

    Munich, Deutschland Precision Medicine Group Vollzeit

    **Position Summary**: To assume regulatory responsibilities including initial and subsequent Clinical Trial submissions to Competent Authority (CA) and Ethics Committees (ECs) in the assigned country(ies) and ensure compliance with local and international clinical trials regulations and guidelines. **Essential functions of the job include but are not...

  • Clinical Trial Leader for Cmr

    vor 2 Wochen

    Munich, Deutschland Boehringer Ingelheim Vollzeit

    **Clinical Trial Leader for CMR** **-** **233665** **OUR COMPANY** At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family-owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are...

  • Medical Director of Clinical Trials

    vor 1 Woche

    Munich, Bayern, Deutschland Pharmiweb Vollzeit

    Company Overview:">Medpace, a leading Contract Research Organization (CRO), is expanding its Clinical Trial Management Group in the DACH region, specifically in Munich, Germany. With a focus on delivering high-quality clinical trials, Medpace provides remote flexibility to its associates with relevant experience.">Salary and Benefits:">We offer a very...

  • Clinical Trial Assistant

    vor 2 Wochen

    Munich, Deutschland Medpace, Inc. Vollzeit

    Job Summary: Role: Clinical Trial Assistant in Clinical Monitoring Training Department. Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Trial Assistant to join our Clinical Monitoring Training and Development team. This position will work in a team to accomplish tasks and projects that are...

  • Clinical Trial Administrator

    vor 2 Wochen

    Munich, Deutschland PSI CRO Vollzeit

    Company Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,600 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...

  • Clinical Trial Coordinator

    vor 7 Monaten

    Munich, Deutschland Thermo Fisher Scientific Vollzeit

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...

  • Clinical Director, Clinical Research

    vor 7 Monaten

    Munich, Deutschland MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we ‘follow the science’ and that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference...

  • Clinical Trial Coordinator

    vor 7 Monaten

    Munich, Deutschland Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Clinical Trial Leader for Central Nervous System

    vor 2 Wochen

    Munich, Deutschland Boehringer Ingelheim Vollzeit

    **Clinical Trial Leader for Central Nervous System** **-** **233662** **OUR COMPANY** At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family-owned company, we focus on long-term performance. We believe that, if we have talented and ambitious...

  • Clinical Trial Coordinator

    vor 7 Monaten

    Munich, Deutschland Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Sr Clinical Research Associate

    vor 7 Monaten

    Munich, Deutschland Thermo Fisher Scientific Vollzeit

    **Senior CRA - Germany** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking...

  • Director Clinical Development

    vor 7 Monaten

    Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

    Oversees one or more trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and regulatory strategy; Drafts protocol profiles and sections of key submission...

  • Clinical Trial Coordinator

    vor 2 Wochen

    Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

    The clinical trial coordinator will support the Senior Project Leader in all aspects of interventional and non-interventional studies in cardiovascular and oncology (study start up, study conduct, study closure, study results delivery). ***Key responsibilities**: - Responsible for the day-to-day logistics of assigned study related tasks. The main...

  • Regulatory Submissions Technical Advisor

    vor 1 Woche

    Munich, Deutschland Medpace, Inc. Vollzeit

    Job Summary: Our clinical operations activities are growing rapidly and we are currently seeking full-time, Regulatory Submissions Technical Advisors to join our Site Activation and Maintenance team, within Clinical Operations. This position plays a key role at Medpace, preparing and reviewing regulatory documents and providing strategic regulatory advice...