EMA Procedure and Liaison Manager

17 Jul 2019
03 Aug 2019
Regulatory Affairs
Full Time
Experienced (non-manager)
We are offering you an opportunity to join our EU Product Development Regulatory Team. Our highly motivated team is a key partner in navigating the EU regulatory environment. We closely collaborate with many other functions in PDR such as Program Management, Emerging,Regional Affiliates Support (ERAS), Regulatory operations, as well as with PTR (Pharma Technical Regulatory) and Artworks, as needed.

As an EMA Procedure and Liaison Manager you are an expert on EMA general procedural aspects. Together with members of the EU Regulatory organization, such as the EU Regulatory Intelligence team and the EU Policy Head you advise on specific EU regulatory issues such as legislation, guidelines, procedures. You are pivotal in spotting opportunities to influence in the Centralized and other EMA procedures. You contribute to the development and the implementation of best practices and operational excellence within the department and cross-functionally to increase efficiency, consistency and compliance with regulatory requirements. More precisely, you:
  • Continuously update and Maintain platforms and tools for EU registration procedures and EU scientific advice in collaboration with other PDR functions
  • Are the EMA interface for e-business pipeline updates and general procedural questions. You support organization of EMA portfolio meetings together with the EU PDR Head and other PDR leads
  • Coordinate MAH-related activities (Roche Registration GmBH) with EMA, Roche Germany, Clinical trial group, EU Program Management ,ERAS and others
  • Support organization of venues and networks to share information/learnings on EMA procedures
  • When appropriate, you coordinate centralized procedure submissions affecting all registered products (e.g MAH transfer, accession, others)
  • Liaise with EU QPPV office as appropriate (responsible for PV system summary)
  • Are involved in training/identifying training and communication needs for EU regulatory community on EU processes.

What else are we offering?

We are dedicated to support our staff in development of their knowledge and skills and offer further career opportunities locally and globally where people demonstrate talent and aptitude.

Who are we looking for?

We are seeking a committed individual who brings:
  • A University degree, preferably in a scientific/technical discipline, 2-5 year's experience in EU Regulatory (Industry or Health Authority) and a deep and hands-on knowledge of EU regulatory procedures and environment.
  • Communication and Negotiation Skills: You are able to influence individuals or groups on more than one level who may have different interests or goals to reach consensus and achieve team objectives
  • Relationship and trust building: You have demonstrated the ability to create trustworthy partnerships with Health Authorities
  • Teamwork: You effectively work in matrix environment to share responsibility as a team member.
  • Strategic and Innovative Thinking: You apply regulatory and scientific knowledge to determine solutions and solve complex problems. You develop clear, effective and creative regulatory communications and strategies to achieve goals
  • Leadership: You provide operational/strategic input, set milestones, allocate responsibility and monitor the progress towards results. You can efficiently lead multiple projects and initiatives.

Ready to apply?

Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs