Senior Manager Regulatory Affairs Oncology (m/f/x)

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Date: 16-Oct-2021

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

 

Passion for Innovation. Compassion for Patients.

 


Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

 

For our Headquarter in Munich we are seeking two highly qualified candidates to fill the position:

 

Senior Manager Regulatory Affairs Oncology (m/f/x)

Purpose of the function:

To provide European regulatory strategy support for assigned projects, products and non-project work. Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a multi-disciplinary team, providing expertise on regulatory matters. Represent Regulatory Affairs in external interactions (e.g. authorities, affiliates, partners, CROs) providing expertise on regulatory strategy to achieve regional and global goals.


Role and Responsibilities

  • European regulatory strategy support for assigned projects, covering product development plans, clinical trials and Marketing Authorizations Applications (MAA) as well as product life cycle management.

  • European Regulatory Affairs representation on global development teams providing regulatory guidance and strategy and supporting EU MAA submissions

  • Act as regulatory contact person for authorities for assigned projects

  • Participate in assigned non-project tasks and process improvements

  • Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders
     

Personal skills and professional experience

  • Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred; Master Degree in Regulatory Affairs is a plus

  • Minimum of 8 years of experience in the pharmaceutical industry and minimum of 5 years of experience in global regulatory affairs with emphasis on late stage drug development and marketing authorization applications in Europe, experience with clinical trials, orphan drugs and pediatric clinical development

  • Experience of working in global environment as well as with National Health Agencies and EMA

  • Proven ability to plan, coordinate and lead activities simultaneously on multiple project

  • Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation

  • Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner

  • Solution and detail-oriented; well organised and self-motivated

  • Excellent written and oral communication skills in English, second language preferred

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.