Requisition ID: REG003851 MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125:year legacy. MSD's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD's Regulatory Affairs division helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results:driven individuals, we're a global network on the leading:edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.
This position is responsible and accountable for all matters related to the planning, development, approval and rejection of product registration processes, as MSD policies and procedures, GMP requirements and local legislation in Central America and Caribbean Countries. Responsible for ensuring the appropriate filing/documentation related to product changes.
Main Responsibilities:
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Provides strategic input and regulatory support for local submissions including preparation, samples and legal documentation request, as required ensuring compliance with regulatory expectations.
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Serves as a liaison with local regulatory authority as required, to facilitate the review, responses to questions and approval of all local submissions on a timely manner. In addition, to monitor completion of any post approval commitments.
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Provides regulatory support for the timely submission of new drug applications, variations and clinical trial applications, in accordance with local regulatory requirements.
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Manages all issues with regard to re:registrations/renewals of products, in compliance with time:lines set by the respective regulatory authorities, and communicated in the re:registration/renewal plan.
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Manages and updates all internally required reporting activities.
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Supports and reviews, communication disclosures and promotional activity, in accordance with local licenses, regulations and ethics codes.
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Provides regulatory support for cross functional activities within the affiliate e.g. Pharmacovigilance (PV), Pricing, Reimbursement Activity (if applicable), and government bids, among others.
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Developments and maintains a consolidated work plan with estimated/actual submission and approval dates.
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Maintains list of date of tender requirements.
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Makes timely updates of regulatory communication systems.Qualifications
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Degree: Pharmacist, Industrial/Chemical Engineer.
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3 to 5 years in Regulatory Affairs or Quality Assurance/Operations at Pharmaceutical Industry.
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Good knowledge of ICH, GMPs systems, Project Managements and pharmaceutical products regulations.
Knowledge
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Central America and Caribbean countries legal regulations
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Communication skills
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Leadership behaviors
Skills
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Dynamic, organized, proactive, responsible, committed, good communication skills
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Proficient in MS Office software
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Ability to work cross:functionally in pharmaceutical company environment
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Time management
Language
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Spanish
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English (Reading, writing and speaking) :advanced level
Job: Regulatory Affairs Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 20 of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD:ul
