Senior Specialist Regional Submission Planner

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The Regulatory Submissions Planner will work within the MSD Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations International Europe, Middle-East and Africa (RAOI-EMEA) department in Europe.

The Regulatory Submissions Planner supports the regulatory submission planning and execution process for the whole of the EMEA portfolio.

As a member of cross-functional team and for the assigned products, her/she will manage all operational aspects for submission planning and execution of Original Marketing application and post-approval regulatory changes.

This position requires a high-level expertise and knowledge of the regulatory landscape across the EMEA Region, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).

Primary Activities include but are not limited to:

• Planning and managing regulatory operation projects from authorization through delivery to country regulatory affairs teams and/or Health Authorities.
• Responsible for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
• Lead or participate in cross-functional forums and meetings
• Work closely with the central planner based in the HQ (US) on assigned products/projects.
• Drive the submission assembly and delivery process with the Global and/or Regional 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).

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 in a multicultural environment.
• 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.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R127827