AP Regional Submissions Lead (Hybrid)

MSD; Makati; Hybrid; PHP 700,000 - 1,200,000; Full time

Job summary

Merck & Co., Inc. is seeking a Specialist Regional Submissions Planner to support AP region regulatory operations, coordinating submission planning and cross-functional activities. The role emphasizes independent management of submission plans and documentation across product lifecycles in a multicultural environment.

You will work with a central HQ planner and regional teams to ensure timely regulatory submissions and continuous process improvements. Hybrid work arrangement is offered.

Qualifications

• Bachelor’s degree in Life Science, Pharmacy or Engineering related discipline.
• At least 2 years’ experience in the pharmaceutical industry in operational roles, project management or regulatory affairs.
• Strong written and oral communication skills in English.

Responsibilities

• Plan and manage regulatory operation projects from authorization through delivery to country regulatory affairs teams and/or Health Authorities.
• Develop and maintain the regulatory submission plan for the assigned projects/products and maintain related project milestones.
• Facilitate and participate in cross-functional forums and meetings to ensure smooth planning, execution and communication of regulatory submission activities.
• Work closely with the central planner based in HQ (US) on assigned products/projects.
• Drive the submission assembly and delivery process with Global/Regional Submission Publishing team to ensure timely assembly, publishing, and archival of submissions.
• Access and maintain the regulatory systems and databases to fulfill daily functions.
• Assist in identifying opportunities to improve efficiency of the submission process and participate in process improvement projects.
• Maintain knowledge on regional regulatory procedures and guidelines.

Skills

eCTD

Regulatory Compliance

Regulatory Affairs

Project Management

Regional Planning

Publishing

Life Sciences

Pharmaceutical Industry

Cross Cultural Management

Adaptability

Education

Bachelor’s degree in Life Science/Pharmacy/Engineering

Job description

Merck & Co., Inc. is seeking a Specialist Regional Submissions Planner to support AP region regulatory operations, coordinating submission planning and cross-functional activities. The role emphasizes independent management of submission plans and documentation across product lifecycles in a multicultural environment.

You will work with a central HQ planner and regional teams to ensure timely regulatory submissions and continuous process improvements. Hybrid work arrangement is offered.