NL-Sr. Manager Regulatory Affairs

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Date: 03-Nov-2022

Location: Nationwide, Netherlands, 1014BA

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.nl.

 

 

 

For our Regulatory Affairs Department we are seeking highly qualified candidates to fill the position:

 

Sr. Regulatory Affairs Manager Benelux

 

 

 

 

 

Reporting line

The Sr. Regulatory Affairs Manager reports to the Executive Director Regulatory Affairs. The position will be based either in The Netherlands or Belgium.

 

 

Accountabilities / Measures:

 

  • Act as the regulatory liaison and primary contact person for MEB, support or lead negotiations on regulatory issues and organize meetings and teleconferences, if required.
  • In close collaboration with the RA & Quality Manager BENELUX provide regulatory support for products marketed in Belgium and Luxemburg.
  • Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives with particular focus on Dutch national regulations. Communicate important changes and trends within Regulatory Affairs and Dutch affiliate business functions when relevant. Design and revise SOPs and SOIs if required.
  • Where applicable, mentor/instruct and provide guidance to internal and external reports including consultants and Clinical Research Organisations. Plan, assign and direct work; manage competing priorities as appropriate.
  • Where required, working with the European Regulatory Team provide regulatory advice on matters related to interventional and non-interventional clinical trials in the Netherlands.
  • Support the preparation of documents and dossiers for national Pricing and Reimbursement /Market Access submissions and discussions.
  • In close collaboration with the European Regulatory Team develop regulatory strategies and advice and provide clear guidance and information to internal and external stakeholders in Daiichi Sankyo Netherlands.
  • Advise on national submission matters and any specific additional national requirements, identify deficiencies requiring resolution.
  • Provide and prepare national information and documents for submission including documents required for labelling and artwork implementations.
  • Maintain licenses of approved products, initiate and supervise implementation of changes; provide oversight and ensure regulatory compliance. Keep the EU headquarter informed about the status of submissions and implementation of changes.
  • Provide launch support and advise on supply questions of medicinal products to patients.
  • Represent Regulatory Affairs and/or DS in internal and external interactions and liaise with functional groups at the Dutch Affiliate, multidisciplinary project and working teams, license partners, authorities, and industry associations. Build up strong relationship with internal and external stakeholders at the Dutch affiliate and EU head office.
  • Lead or support projects to enhance the functionality and improve processes of the organization and/or to adapt to a regulatory environment.

 

 

What do you bring:

 

Essential 

  • Degree in Pharmacy, Medicine, Life or Natural Sciences.
  • Deep knowledge of European and Dutch national laws, regulations, guidelines and other requirements for human medicinal product marketing authorization and maintenance is essential.
  • +5 yrs Working experience in pharmaceutical industry, in Clinical Research Organizations or at a regulatory authority with proven experience in regulatory affairs with an emphasis on regulatory pre-submission and post-approval activities and preparation of new marketing authorization in the Netherlands and Europe.
  • Working experience with MEB
  • Excellent interpersonal skills. Ability to communicate and work across functions effectively in a multinational organization to accomplish results.
  • Be detailed-oriented, well organized and self-motivated. Proven ability to plan, coordinate and lead activities simultaneously on multiple projects.
  • Very high ethical standards.
  • Understanding of development and life-cycle management of drugs and regulatory processes. Ability to interact and communicate effectively with regulatory authorities and stakeholders.
  • Computer proficiency (e. g. MS office, document management systems, databases), native level Dutch and excellent written and verbal communication skills in English and French.

 

     Desirable

  • PhD, post-doctorate or professional experience in pre-clinical research or clinical development, a TOPRA diploma or Master Degree in Regulatory Affairs or other relevant specialization.
  • Experience in Oncology and centrally approved products

 

 

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.