Regulatory Affairs - Clinical Trials Support (m/f/x)

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Date: 10-Jan-2022

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 highly qualified candidates to fill the position:


Regulatory Affairs - Clinical Trials Support (m/f/x)


Purpose of the function:


To serve as the European regulatory coordinator and support for assigned projects, products and non-project work in the area of Clinical Trials. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally to become a fully recognized support function of clinical study teams and relevant stakeholder, providing support to EU regulatory strategists. Represent Regulatory Affairs working with authorities, affiliates, partners and CROs.

 


Roles and Responsibilities:

 

  • Act as a regulatory contact person for European clinical trial matters 
  • Acts as the EU interface with CROs for regulatory submissions related to Clinical Trials
  • Act as a coordinator of responses to agency questions for studies under CTR
  • Review and interpret regulatory guidelines, especially the CTR and provide guidance to peers and direct reports regarding regulatory issues
  • Advises the regulatory strategist and EU product leads on CTA submission strategy and evaluates the adequacy of the content of regulatory submissions and identifies deficiencies requiring further resolution
  • Provide regulatory support and guidance as required for the preparation of documents required for regulatory submissions for example Investigational Medicinal Product Dossier (IMPD) or Response to Queries
  • As assigned by manager participate or lead 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. Also communicates with outside consultants (i.e. CRO's) as needed

 

 

Qualification and Requirements:

 

  • Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master preferred; Master Degree in Regulatory Affairs is a plus
  • Minimum of 3 years of experience in Clinical Trials 
  • Experience of working in global environment
  • Experience of working with CROs, National Health Agencies and EMA
  • 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
  • Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner
  • Solution and detail-oriented; well organized 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.