Director Regulatory Affairs Cmc - Pfaffenhofen an der Ilm, Deutschland - Daiichi-Sankyo Europe

Daiichi-Sankyo Europe

Geprüftes Unternehmen

Pfaffenhofen an der Ilm, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Passion for Innovation

Compassion for Patients:

Director Regulatory Affairs CMC (M/F/x):

Purpose of the function:

The Director RACMC 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 interactions in scientific advices, CMOs).

The function will lead the preparation of regulatory CMC documents during development and life cycle management as IMPDs and MAAs in a manner that is scientifically sound, commercially viable and in accordance with regulatory CMC standards.

The function may act as a specialist for biological products in the EU regulatory CMC field.

The function communicates EU and international regulatory requirements to authoring teams, develop the EU regulatory strategies and review dossiers and technical documents.

The function and the team collaborates companywide within the global RACMC department and technical functions. The function is proactively influencing the internal, but also external regulatory affairs environment.

Roles and responsibilities:

Lead regulatory teams to conduct preparation of M2 and M3 CTD documents for EU MAAs and IMPDs filings of new drugs, incl. Quality Overall Summary (QOS).
Represent EU RACMC function in global RACMC and CMC development teams and provide CMC regulatory guidance and strategy
Review CMC documents, develop regulatory strategies, provide risk assessments
Lead 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, communicate important changes and trends with the relevant stakeholders
Participate or lead assigned nonproject tasks and process improvements
Influence the EU regulatory landscape

Personal skills and professional experience:

Master degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus
Minimum of 8 years of experience in the pharmaceutical industry
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 organisation
Experience of working in global environment in interdisciplinary teams
Experience of leading interdisciplinary teams
Solution and detailoriented; well organised and selfmotivated
Excellent written and oral communication skills in English, German as a second language preferred
Strong working knowledge of Microsoft Office

What we offer:

Working at Daiichi Sankyo:

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients' needs.

We know that our bold ambition to change patients' lives for the better can only be achieved through the power of collaboration and the exploration of new approaches.

Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow.

When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.