Regional Submissions Planner – AP Regulatory Operations

Merck Gruppe - MSD Sharp & Dohme; Rahway (NJ); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme is seeking a Specialist Regional Submissions Planner within GRACS, RRO. You will support regional regulatory submission planning for the AP region and contribute to cross-regional planning, ensuring timely regulatory and safety submissions for approval.

You will manage submission plans independently across all product lifecycle stages, collaborate with stakeholders, and participate in process improvements or strategic initiatives in a multicultural,

Qualifications

• Bachelor's degree in Life Science, Pharmacy or Engineering required.
• At least 2 years in pharma in operational roles, PM or regulatory affairs.
• Strong written and oral English communication.

Responsibilities

• Plan and manage regulatory operation projects from authorization through delivery to country teams.
• Develop and maintain the regulatory submission plan and milestones.
• Facilitate cross-functional forums to ensure timely submission activities.
• Work closely with HQ central planner on assigned products/projects.
• Drive submission assembly and delivery with publishing teams.
• Access and maintain regulatory systems and databases for daily tasks.
• Identify opportunities to improve submission efficiency and participate in process improvements.
• Maintain knowledge of regional regulatory procedures and guidelines.

Skills

eCTD

Regulatory Affairs

Project Management

Cross-cultural Management

Life Science

Pharmaceutical Industry

Education

Bachelor's degree in Life Science

Job description

Merck Gruppe - MSD Sharp & Dohme is seeking a Specialist Regional Submissions Planner within GRACS, RRO. You will support regional regulatory submission planning for the AP region and contribute to cross-regional planning, ensuring timely regulatory and safety submissions for approval.

You will manage submission plans independently across all product lifecycle stages, collaborate with stakeholders, and participate in process improvements or strategic initiatives in a multicultural,