Team Associate Regulatory Affairs (m/f/x)

Apply now »

Date: 30-Mar-2019

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

Affiliate: Daiichi Sankyo Europe GmbH

 

Passion for Innovation. Compassion for Patients.™

Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, the Group’s 2025 vision is to become a “Global Pharma Innovator with Competitive Advantage in Oncology”. Our European headquarters are in Munich, Germany and we have affiliates in 12 European countries. For more information: www.daiichi-sankyo.eu.

 

For our Regulatory Affairs team in our European headquarters in Munich we are seeking highly qualified candidates to fill the position:

 

 

Team Associate Regulatory Affairs (m/f/x)

 

 

 

The position:

The Team Associate Regulatory Affairs will provide administrative and operational regulatory support to apply for or to maintain European or international marketing authorizations for assigned products. Furthermore he/she will support the regulatory oversight and compliance and will act as a specialist with regard to specific field of regulatory or technical knowledge.

 

 

Key responsibilities:

  • To prepare or support the preparation of regulatory documents and registration dossiers including QC and archiving
  • To submit the prepared submission including necessary formal information to agencies
  • To monitor and track submissions and deadlines
  • To coordinate the preparation of mock-ups and packaging materials, including QC of specific packaging material
  • To act as primary contact for DSE affiliates and license partners
  • To closely cooperate with other functions within the organization and external partners in order to maintain existing marketing authorizations and to support new product registrations
  • To be responsible for SAP-entries and other internal and external database entries
  • To support electronic publishing
  • To prepare budgets and support accounting for regulatory fees
  • General administrative support

 

Professional experience and personal skills:

  • Education as Technical assistant (PTA, MTA, CTA, BTA, lab assistant), translator or equivalent
  • 3 to 5 years working experience in Regulatory Affairs in pharmaceutical companies or a Clinical Research Organization
  • Experience with the preparation and preferably publishing of Common Technical Documents
  • Team oriented and forward thinking attitude
  • Strong interpersonal and communication skills
  • Structural and independently way to work, talent for organisation
  • Computer proficiency (e.g. MS office)
  • Written and oral communication skills in English and German, third language preferred

 

 

What we offer:

 

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.