Regulatory Site Officer (m/f/d)

Einsatzort: Frankfurt am Main

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Regulatory Site Officer (m/f/d)

The Regulatory Site Officer (RSO) is responsible to ensure and conduct compliant regulatory CMC (chemistry, manufacturing and controls) activities. The major focus is related to the marketing authorization dossiers worldwide for the manufacturing site in collaboration with global regulatory affairs and other internal as well as external functions.

Responsibilities

Regulatory Compliance

  • Supports batch release by following submission and approval to ensure the product regulatory compliance
  • Ensures that the CMC dossier is in line with manufacturing and control procedures and with dossiers approved by health authorities
  • Contributes to site inspections and audits
  • Supports product licenses maintenance and site registration
  • Reviews and signs-off documents like SOPs or technical reports

Change Control

  • Assesses and manages change control activities with regulatory impact for the site
  • Provides regulatory expertise to site projects
  • Manages regulatory activities linked to change controls including updating of the CMC files

CMC Documentation Management

  • Supports Marketing authorisations worldwide (territory extensions, renewals, site registrations and transfers, new submissions) by writing and approving the corresponding CMC documents/dossiers and collecting GMP related documents
  • Optimizes the content of CMC dossiers to facilitate the management of future changes
  • Facilitates the introduction of new products, process technologies and continuous improvement projects
  • Writes ready for submission CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions and supports CMC writing performed for other entities (internal or external)
  • Prepares with contribution of site experts answers to questions from Health Authorities
  • Consolidates all regulatory activities via good planning
  • Indication when approved variations can be implemented

Transversal Activities

  • Acts as the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs for the site
  • Ensures the regulatory surveillance on his/her specific field of competencies and communicates the appropriate information
  • Provides results of regulatory indicators applicable to the site

Requirements

  • Ph.D or Master in a science/health field (e.g. mathematics, chemistry, pharmacy, biology, biotechnology sciences etc.) or equivalent
  • Knowledge of global regulations/guidelines, key health authority/industry thinking and trends is a must
  • Minimum 2-5 years of direct regulatory CMC experience is preferred
  • Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is desirable
  • Experience of manufacturing operations, biotechnologies, biological products is a plus
  • Capability of resolving strategic technical and regulatory issues
  • Should demonstrate initiative, independent thinking, anticipatory foresight
  • Strong communication skills
  • Ability to make decisions in a highly moving environment
  • Business level in German and English (written & spoken)

Our offer

  • An internatio­nal work environ­ment, in which you can develop your talent and realize ideas and inno­vations within a compe­tent team.
  • An attractive, market-oriented salary aligned with your qualifi­cations and including social benefits above average (e.g. company pension plans, health manage­ment).
  • An individual and well-struc­tured intro­duc­tion and training of new employees.
  • You can create your own career path within Sanofi. Your profes­sio­nal and personal de­velop­ment will be suppor­ted purposefully.
  • As a globally successful and constantly growing company, Sanofi provides inter­national career paths as well.

If you are interested, please send us your online application.

Sanofi-Aventis Deutschland GmbH http://www.sanofi-aventis.de http://www.sanofi-aventis.de https://files.relaxx.center/kcenter-google-postings/kc-276/logo_google.png
2020-01-01T09:00:29.595Z FULL_TIME
EUR
YEAR null
2019-11-06
Frankfurt am Main 65929 Industriepark Höchst
50.0840632 8.5478771