Regulatory Affairs Analyst:REG002991
Description
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.
Under guidance of the Regulatory Coordinator, depending upon project, the incumbent is responsible for collecting and preparing documentation used by regulatory agencies in CACAR in connection with variations involving products approved through the centralized, mutual recognition and concertation procedures. Also incumbent is assisting the process of harmonization of artworks, procedures of samples and analytical standards and the follow up to the submission at authorities of CACAR and the report of Pharmacovigilance.
Major Activities and Responsibilities:
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Arranges for timely submissions of the variation notifications/applications and responses in liaison with subsidiary registration managers when needed.
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Responsible for all registration process in Panamá (Registration application,renewals, variations and notifications) .
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Supports the harmonization artworks for CACAR.
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Does the requirements and follow up at the request of analytical standards and samples for CACAR.
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Supports the answers of technical concepts generated for CACAR authorities.
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Plan and perform a regulatory process including preparation of documents for New Registrations, Renewals and PACs for E Salvador, Venezuela and islands.
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Submission, follow up before the Agency and notification of approval letters.
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Does follow up at Pharmacovigilance cases reported in the region.
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Assists with administrative support during filing and review of any centralized submission to safeguard submissions according to CACAR requirements.
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Provides other administrative support to CACAR Regulatory Liaison as needed.
Qualifications
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Education: Veterinary or Pharmaceutical Degree
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Specialty Science related to animal health of pharmaceutical industry (desirable)
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Experience: More than one year in Regulatory Affairs at Pharmaceutical Industry
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Good knowledge of GMP and local regulations.
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English (Reading, writing and speaking) :Medium:advanced level
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Knowledge: Central America and Caribbean legal regulations
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Leadership behaviors
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we're inventing for life.
MSDHJ082017
Job: Regulatory Affairs Generic Job Title:Spclst, Regulatory Affairs
Primary Location: LATAM:Panama:Panamá:Panamá
Employee Status: Regular
Travel: No
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:MSD
Salario:Competitive
