Regulatory Affairs Planning Partner

Are you motivated by ensuring effective planning of regulatory submissions worldwide? Do you thrive in an international environment, coordinating between different global stakeholders? And do you have a flair for working with data and business intelligence tools? You now have the great opportunity to join the Regulatory Affairs Planning and Processes team as a Regulatory Planning Partner in the Regulatory Affairs CMC and Device

Apply now for a life-changing career!

The position

You will join a growing department and get your own individual area of responsibility, supporting part of the manufacturing portfolio. As a partner to affiliates, Regulatory Affairs (RA) areas, and Product Supply (PS), you will be responsible for the submission planning of global rollouts of life cycle management (LCM) variations, enabling the RA headquarter function to support affiliates with realistic, transparent plans.

The position requires analytical skills and the ability to create good, structured overviews of regulatory activities. We enable high-level reporting of detailed submission information and develop structured summaries for management and stakeholders around the organization. Focus is needed on following up and providing tactical plans with all affiliates across the world for LCM changes, submissions of a new manufacturing site, or an optimized process in manufacturing.

Your main tasks will include:

The RA Planning and Processes team is newly established, and you will also have the chance to shape how we work. You will be part of a transformational journey, actively participating in establishing new LCM processes and supporting IT solutions and tools for proactive submission planning.

Qualifications

As a person, you need to be a dedicated team player, build good working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills.

To be successful in this role, you need the following:

About the department

Regulatory Affairs Planning and Processes is part of the Submission Excellence area in RA CMC & Device. RA CMC and Device is one of two headquarter-based regulatory functions with the responsibility to drive regulatory strategies for projects from the early phases to the LCM of marketed products worldwide.

Submission Excellence is a relatively new area, consisting of four departments. We have the overall purpose of driving an ambitious LCM agenda to ensure flexibility in the supply network and to act as strategic partners for manufacturing and capacity expansion projects. We have a key role in setting the regulatory strategies, streamlining processes, and ensuring fast and efficient global rollout and approvals.

RA Planning and Processes currently comprises six colleagues, with an expectation of further growth. The primary role is to manage the streamlined, well-governed planning of all regulatory submissions across the world. The main stakeholders are PS, Supply Chain, and regulatory functions in the global affiliates and headquarters, primarily within RA CMC & Device. The PS and Supply Chain areas are setting directions for how to best optimize and utilize our global manufacturing network, and our role is to be a strategic partner, balancing regulatory requirements into an optimal plan for executing on approvals of manufacturing site additions and optimization. The profile of the colleagues in the team is very diverse, covering everything from regulatory experience to data and business analysts.