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:

Adaptability, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Technical Writing

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

09/30/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.