Manager CMC Regulatory Affairs (m/f/x) - limited to 3 years -

Apply now »

Date: 06-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:

 

Manager CMC Regulatory Affairs (m/f/x) 

- limited to 3 years -

 

The position:

 

The Manager RACMC supports the regulatory life cycle management and maintenance in DSE territories (EU and non-EU), provides regulatory guidance and strategy to assigned regulatory projects and approved products in a manner that is scientifically sound, commercially viable and in accordance with regulatory standards, drug laws and regulations. This activity includes all quality aspects (Module 2 and 3) of the marketing authorization. In this role, the manager ensures maintenance of approved products, provides regulatory oversight and ensures regulatory compliance. 
The Manager RACMC communicates EU and international regulatory requirements to authoring teams and develops the regulatory strategies and collaborates companywide within the RACMC department and subject matter experts.

 

Roles and responsibilities:

 

  • Represent EU RACMC in global regulatory, supply chain and development teams and provide regulatory guidance and strategy for assigned projects and products
  • Liaise, negotiate and communicate with functional groups within Daiichi Sankyo, corporate partners, affiliates and agencies to obtain and/or provide information/data for regulatory submissions
  • Interpret, develop strategy and lead response preparation on Health Authority information requests
  • Lead preparation of M2.3 (Quality Overall Summary) and M3 CTD documents for development, EU MAAs and LCM  filings to European and other assigned non-EU authorities 
  • Provides operational regulatory support in document authoring, review and document management system 
  • Develop regulatory strategies, provide risk assessments
  • Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders
  • Participate in or lead assigned non-project tasks designed to enhance the functionality and processes of RACMC

 

Personal skills and professional experience:

 

  • Degree (Bachelor, Master, State Examination, Diploma) in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus 
  • Working experience in pharmaceutical industry, in Clinical Research Organizations or in a regulatory authority with at least 2 years work experience in regulatory affairs with an emphasis on New Drug Applications or regulatory life cycle management activities in Europe (EU and non-EU) and international markets
  • Proven ability to plan, coordinate 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 is a plus
  • 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

 

 

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.