Regulatory Submissions Planner - Costa Rica

Job Description

The Regulatory Submissions Planner supports the preparation of regulatory submissions and manages registration tracking from a regulatory operations perspective ensuring alignment with strategic target dates across the region.

As part of a cross-functional team and assigned programs, he/she/they will manage all operational activities for submission planning and execution of Original Marketing Applications (OMA) and other post-approval submissions.

This role requires advanced expertise and knowledge of the regulatory landscape across the Latin America Region, including regional registration procedures and a comprehensive understanding of dossier technical requirements.

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.

• Participate in cross-functional forums and meetings.

• Work closely with other stakeholders 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 of regional regulatory procedures on internal and external guidelines and standards.

Education Requirements:

• Bachelor’s Degree in a Science, Pharmacy or related discipline required.

Experience and Skills:

• With at least 2 years’ experience in the regulatory operations area, regulatory affairs will be an asset.
• Advanced English
• Able to manage multiple priorities with proven project management skills, including coordinating dynamic timelines, negotiating and collaborating effectively with stakeholders, and consistently following through completion.
• Thorough knowledge of regulatory guidelines and procedures within the Latin America region is preferable.
• Excellent communication skills to manage interactions with colleagues in a multicultural environment.
• Ability to maintain a clear overview of complex processes involved in planning, managing, tracking, assembling and delivering regulatory content to support regulatory strategy, ensure compliance, and meet informational needs of internal and external stakeholders.
• Ability to perform effectively under time pressure and to manage the impacts of any delays in timely submissions.
• Aptitude for working with complex IT systems.

Required Skills:

Preferred Skills:

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