Job Description

The Regulatory Submission Planner will work within the Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional Regulatory Operations Asia Pacific (RRO-AP).

The Regulatory Submission 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 AP region.

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 (OMA) and post-approval regulatory changes.

This position requires a high-level expertise and knowledge of the regulatory landscape across the AP 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 and cross-regional 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 regional regulatory procedures on internal and external guidelines and standards.

Education Minimum Requirement:

•  Bachelor’s degree in a Life Science related discipline.

Experience and Skills:

• At least 3-4 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 AP region is required.
• 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.

Note: There is no relocation for the role. The successful candidate will work remotely from his/her home location.

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/31/2025

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