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Senior Specialist, Regional Regulatory Submissions Planner, Brussels, Belgium Job

Date: Nov 7, 2017

Location: Brussels, BE

Company: MSD

Requisition ID: REG003186

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. MRL is a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

We have an exciting opportunity for a Regulatory Submissions Planner, Regulatory Operations, to join our team in Brussels, Belgium.

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 (Brussels, BE).

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, her/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). Regulatory knowledge of the wider region (i.e.: non EU CES, CIS, Middle East and Africa) will be an advantage for this role.

Main responsibilities:

• 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.

o Lead Submission Planning Management Teams (SPMT) meetings

o Work closely with the corresponding Planner based in the HQ(US) on assigned products/projects

o 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).

Qualifications

Education Requirements:
• Bachelors degree in a Life Science related discipline.

Experience and Skills:

• 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 required and knowledge of submissions in the wider region (CIS states and Africa) 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.

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life. 

Recruitment Agency / Search Firm representatives please note:
MSD will not accept unsolicited CVs from recruitment agencies / search firms under any circumstances. In order to present CVs to MSD, your Recruitment Agency / Search Firm will have been invited to work on a specific vacancy and have Terms of Business signed and agreed with the relevant Recruitment and Staffing Regional Lead. Should you send CVs for a vacancy that you have not been specifically invited to work on to any employee at MSD (via email, post, internet, Taleo or any other method), these will be deemed the sole property of MSD. MSD will pay no introduction fee to the Recruitment Agency / Search Firm if a candidate is hired as a result of an agency introduction under these circumstances.



Job: Regulatory Affairs Generic
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Employee Status: Regular
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Company Trade Name: MSD


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