Consultant Regulatory Affairs (m/w)

September 2018

März 2019

D-Großraum München

auf Anfrage

04.09.2018

Projektbeschreibung

Typically requires a degree in a scientific field and/or master in regulatory affairs and minimum 4 years of relevant experience in regulatory affairs.
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.


Regulatory Submissions

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.

Kontaktdaten

Als registriertes Mitglied von freelance.de können Sie sich direkt auf dieses Projekt bewerben.

Login

direkt bewerben:


Noch kein Mitglied?

jetzt registrieren »

Projektkategorien

Finanzen, Versicherung, Recht:

Projektstatistiken

Projektstatistiken sind für PREMIUM-Mitglieder einsehbar.

Sie suchen Freelancer?

Schreiben Sie Ihr Projekt kostenlos aus und erhalten noch heute passende Angebote.

jetzt Projekt erstellen »