Regulatory Procedural Management and Clinical Trial

vor 3 Wochen

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?**:

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