Experience in and understanding of role of RA and regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local territory is preferred
Excellent organization skills and ability to work on a number of projects with tight timelines.
Excellent verbal and written communication skills and interpersonal skills.
Interaction with Local Health Authorities (HA)
Supports the management of relevant local HA inspections.
Prepares regulatory (submission) documentation regarding
Quality defects / falsified or counterfeit products / batch recall management.
Out of stock situation management.
Dear Healthcare Provider Communications submissions and follow-up until approval.
Risk Minimization Measures submissions and follow-up until approval.
Prepares regulatory submission to local HAs with some supervision from line manager in line with local HA expectations, concern processes and business objectives for assigned product(s) or projects.
Main types of submissions are (not-exhaustive):
Clinical trials applications, amendments and other clinical trials submissions.
Compassionate Use & Early Access applications.
Risk Minimization Activities materials.
Dear Health Care Professional communication
Local Statutory Responsibilities and Liabilities
Supports the activities to ensure that the company fulfills all requirements linked to the Marketing Authorization/local license as Marketing Authorization Holder or as local representative of the Marketing Authorization Holder.
Compliance with the Relevant Laws and Regulations that Relate to the Core Activities of Regulatory Affairs
Supports all activities to ensure compliance with local law and regulation and consistency with global and local procedural documents.
Supports activities needed to ensure compliant labeling for the company medicinal products in the country (SmPC, PIL, packaging) and manage timely updates for assigned product(s). This includes translation checks and submission to compendia.
Supports activities in relation to Regulatory Compliance audits within the affiliate.
Supports activities required to maintain GDP license in the country, eg support management of 3PL audits, setup of Quality Agreements, etc.
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