Regulatory Submission Planner

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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 Planners will work within the our Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional Regulatory Affairs Operations Europe, Middle-East and Africa (RRO-EMEA) department based in Europe.

The Regional Submissions Planners support the regulatory submission planning and execution process for the whole of the EMEA portfolio.

As a members of the cross-functional team and for the assigned products, they manage all operational aspects for submission planning and execution of Original Marketing Application and post-approval regulatory changes.

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

**What you will do**:
Plan and manage regulatory operation projects from authorization through to delivery to country regulatory affairs teams and/or Health Authorities.
Be accountable for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
Work closely with the HQ planner who is based in the US Headquarters 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 established timelines.
Be accountable 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).

**What we are looking for**:
Bachelors degree in a Life Science related discipline.
Ideally 3+ years’ experience in the regulatory operations area, regulatory affairs will be an asset.
Ability to multitask with proven project management capabilities including managing dynamic timelines, interacting and negotiating with others, partnership skills 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.

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are