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MSD Associate Specialist Regulatory Affairs Argentina, Autonomous City of Buenos Aires, Buenos Aires 918710826
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Job Description
Country Functions & Responsibility:
Under supervision of the Country Sr. Specialist/Assoc. Director Regulatory Affairs, the incumbent is responsible for providing regulatory administrative support and coordination for the department with maintenance of tracking systems and databases, minor translations, preparing submissions and renewals and maintenance of local files as well as minor translations and artwork management.
Under supervision of Country Sr. Specialist/Assoc. Director Regulatory Affairs the incumbent contributes to other regulatory tasks, as required.
Senior position may take on more advanced and independent responsibilities and act as supervisor regarding selected activities.
Cluster Functions & Responsibility:
Labelling Working Group:
In connection with submission of MA applications and post-approval submissions assists in preparation, translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and performs quality assurance including linguistic check of these documents.
Artwork Working Group:
Ensures that artwork including all package components (leaflets, labels, outer cartons etc), is developed in a timely and correct manner and according to relevant Artwork Management procedures.
GMP Working Group:
Ensure validity of GMPs/CPPs certifications issued by foreign Reg. Authorities. Store in Cluster repository and update tracking tool accordingly.
Apply for local GMP inspections: prepare dossier according to country requirements, follow-up submission status and manage RTQs related to these submissions.
License Renewal Working Group:
Participate in the management of License Renewal Process according to cluster schedule.
Monitor timelines are achieved by GENPACK.
Provide countries within the cluster ready-for-submission dossiers in a timely manner.
Compliance Working Group:
Participate in cluster compliance initiatives according to selected priorities focused on continuous improvement.
Perform regulatory assessment for new legislation according to global process meeting local requirements.
Requirements:
B.A./B.S. with strong emphasis in medical and/or biology preferred(pharmacy, biochemistry, biology, genetics, etc).
1 or 2 years of experience in similar positions.
Fluent in English (verbal and written) with excellent communication skills.
Excelent organizational skills and detail oriented, problem solving skills.
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
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.
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