Jobbeschreibung
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.
For our headquarter in Munich we are seeking highly qualified candidates to fill the position:
Senior Manager Regulatory Affairs CMC (m/w/x)
The function of EU Regulatory Affairs CMC:
Within Daiichi Sankyo`s Technology Unit, the role of the EU Regulatory Affairs CMC function is to lead the preparation of dossiers of Daiichi Sankyo's development and commercial products, and to submit to EU and international health authorities. To ensure high quality standards and health authority expectations are met, we are both closely interacting with research and manufacturing functions within Daiichi Sankyo, and aiming to maintain a trustful relationship with health authorities, striving to ensure on-time approval of our drugs and securing patient supply.
The position:
The Senior Manager Regulatory Affairs CMC will provide European regulatory CMC guidance and strategy for assigned products and will represent Regulatory Affairs CMC EU in internal and external interactions (e.g. global and local project teams, working teams, authorities communication (Scientific Advice), CMOs). He/She/It will lead the preparation of regulatory CMC documents for products of diverse modalities (small molecules, biological products or ATMPs) during development and/or commercial stage in a manner that is scientifically sound, commercially viable and in accordance with current regulatory CMC standards. Further, it is a goal of the role to translate latest EU and international regulatory CMC requirements into state of the art, high-quality regulatory CMC documentation, develop EU and international regulatory submission strategies, and review dossiers and technical documents.
- Working in regulatory teams to prepare of M2.3 and M3 CTD documents for EU and international HA for development and commercial filings
- Represent EU RACMC function in global RACMC and CMC teams and provide RA CMC guidance and strategy to project teams
- Review CMC documents, develop regulatory strategies, conduct risk assessments
- Support the preparation and execution of Health Authority meetings
- Interpret, develop strategy and lead response preparation on Health Authorities information requests
- Keep close collaboration with global RACMC colleagues and technical experts across all regions
- Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, and communicate important changes and trends with the relevant stakeholders
- Participate or lead assigned non-project tasks and process improvements
- Ensure maintenance of regulatory compliance
- Master degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus
- Minimum of 5 years of experience in the pharmaceutical industry
- Minimum of 3 years of experience in global regulatory affairs CMC with experience in biologics or small molecules (experience in both preferred)
- Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
- Experience of working in global environment in interdisciplinary teams
- Experience of working in or leading interdisciplinary teams
- Solution and detail-oriented; well organised and self-motivated
- Excellent written and oral communication skills in English, German as a second language preferred
- Strong working knowledge of Microsoft Office
- Excellent Benefits
- Work-Life Balance
- Growth and Development
- Health and Wellbeing Support