Responsibilities of the Support Regulatory Submission Planning
The Regulatory Submissions Planner will work within the MSD Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations Europe, Middle-East and Africa (RAO-EMEA) department in Europe.
The Regulatory Submissions Planner supports the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective for the whole of the EMEA region, with a current focus on Europe.
As a member of cross-functional team and for the assigned products, he/she manages all operational aspects from submission planning, document retrieval, to submission creation and delivery to Health Authorities.
This position requires a high level expertise and knowledge of the European regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD). Primary Activities include but are not limited to:
- Planning, coordinating and reviewing regulatory submissions with release to Country Operations teams and/or submission to Health Authorities.
- Responsible for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
- Lead Submission Planning Management Teams (SPMT) meetings.
- Work closely with the corresponding Planner based in the HQ(US) on assigned products/projects.
- Drive the submission assembly and delivery process with the Global Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions as per the agreed timelines.
- Responsible for accessing and maintaining the regulatory systems and databases to fulfil daily functions.
- Assist in identifying opportunities to continually improve the efficiency of the submission process and participate in small-scale process improvement projects.
- Maintain knowledge on the European and non-European procedures (on internal and external guidelines and standards).
Profile of the Support Regulatory Submission Planning
- Bachelors degree or equivalent in life sciences, business, or other related discipline
- At least 2 years experience in the regulatory operations area, regulatory affairs will be an asset.
- Able to multitask with proven project management capabilities including managing dynamic timelines, interacting and negotiating with others, collaboration skill and excellent follow-up ability
- Thorough knowledge of regulatory guidelines and procedures within the European Region is preferable
- Excellent communication skills to manage interactions with colleagues within and outside the department to co-ordinate the regulatory submission for a timely delivery
- Capability to keep overview in the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs for internal and external customers.
- Ability to handle time pressure and the consequence of any delay in timely submissions.
- Affinity to work with complex IT systems.
Offer for the Support Regulatory Submission Planning
- Challenging projects based on your interests and skills
- Personal follow-up and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees