Merck
Job Description
The Regulatory Submissions Planner will be part of the Regional Regulatory Operations team within the Global Regulatory Affairs and Clinical Safety organization of our company.
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, the incumbent will manage all operational activities from submission planning, and execution of submissions and/or delivery to Health Authorities.
This role requires an advance expertise and knowledge of the Latin American countries’ regulatory landscapes, including regional registration procedures and a comprehensive understanding of dossier technical requirements.
Primary Activities include but are not limited to:
Education Requirements:
• Bachelor’s degree in a Life Science, Engineering, or a related discipline.
• Pharmacy degree preferred.
Experience and Skills:
Languages:
English
Portuguese
Spanish
Preferred Skills:
We take pride in being a company that recognizes the value of bringing together talented and committed people from diverse backgrounds. The fastest way to drive innovation is when diverse ideas come together in an inclusive environment. We encourage our employees to approach challenges collaboratively and to respectfully challenge one another’s thinking. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace where all employees can thrive.
#LaboratoriesBR
Required Skills:
Business, Communication, Cross-Functional Teamwork, Global Regulatory, Government Affairs, Regulatory Compliance, Regulatory Operations
Preferred Skills:
Microsoft Excel, Microsoft PowerPoint, Microsoft SharePoint, Operational Excellence, Operational Performance, Process Management, Stakeholder Engagement
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:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
no
Job Posting End Date:
10/3/2026
*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.