Specialist, Regional Submission Planner

The Specialist Regional Submissions Planner will work within our Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional Regulatory Operations department (RRO), supporting regional planning activities for the AP region while also contributing to cross-regional planning activities as needed. The Regional Submission Planner will support the regulatory submission plan creation and registration tracking of the company’s regulatory submission targets from a regional and cross-regional operational perspective.

This role works closely with various stakeholders to drive the identification, planning, execution, and management of activities to deliver high quality and timely regulatory and safety submissions for approval. The incumbent is expected to demonstrate strong project management skills with the ability to operate in a multicultural environment and experience working in a cross-functional setting.  Should be capable of independent management of all submission plans and documentation, at any level of complexity, across all submission types throughout the product lifecycle. Additionally, the incumbent may be involved in supporting internal or external process improvement or strategic initiatives.

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 the 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 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.
• Access and maintain the regulatory systems and databases to fulfill daily functions.
• Assist in identifying opportunities to continually improve the efficiency of the submission process and participate in process improvement projects.
• Maintain knowledge on the regional regulatory procedures on internal and external guidelines and standards.

Qualifications:

• Bachelor’s degree in a 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.

Desired Skills:

• Ability to multitask with proven project management capabilities, including managing dynamic timelines, interacting, and negotiating with others, collaboration skills, and excellent follow-up ability.
• Working knowledge of regulatory guidelines and procedures within the AP region.
• Excellent communication skills to manage interactions with colleagues in a multicultural environment.
• Capability to keep an overview in the complexity of planning, managing, tracking, assembling, and delivering regulatory content to meet regulatory strategy, regulatory compliance, and informational needs for internal and external customers.
• Ability to handle time pressure and the consequences of any delay in timely submissions including the ability to adjust, modify, or change one's approach, behavior, mindset and/or plan in response to evolving priorities.
• Affinity to work with complex IT systems.

Additional location(s) Compensation Information:

Required Skills:

Adaptability, Adaptability, Communication Sciences, Cross Cultural Management, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, Enterprise Project Management (EPM), Life Science, Life Sciences Industry, Pharmaceutical Industry, Pharmaceutical Regulatory Affairs, Pharmaceutics, Pharmacovigilance, Process Improvements, Project Cycle Management (PCM), Project Management, Project Management Tools, Publishing, Regional Planning, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Reporting {+ 8 more}

Preferred Skills:

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