Regulatory Procedural Management and Clinical Trial Lead

Gefunden in: Talent DE C2 - vor 2 Wochen

Munich, Deutschland Daiichi Sankyo Europe Vollzeit

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

We are seeking highly qualified candidates to fill the position:

Regulatory Procedural Management and Clinical Trial Lead (m/f/x), Regulatory Affairs Europe

The Position:

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. 
In this role, lead EU & AMELA Regulatory Procedural Management and Clinical Trial Office providing regulatory oversight and ensuring smooth run of regulatory procedures, clinical trial applications and regulatory procedural as well as compliance.
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 clinical trials, 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 teams and other functions:

Lead the Regulatory Procedural Procedure & 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 Lead the EU & AMELA Regulatory Procedure & Management team and provide managerial and regulatory procedural guidance and operational strategy for development projects and marketed products Provide managerial support and oversight to the Clinical Trial Office Team in the EU to ensure smooth regulatory applications of clinical trials and regulatory clinical trial compliance in the EU 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. Working experience in pharmaceutical industry, in Clinical Research Organizations or in a regulatory authority with at least 10 year experience in regulatory affairs with an emphasis on regulatory pre-submission and post-approval activities and preparation of new global marketing applications (EU and non-EU) and major regulatory submissions and supplemental amendments/major variations. Experience in paediatric development. 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?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

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