Regulatory Expert (m/w/d) - befristet bis 30.11.2022

Job description

Responsibilities

·  Ensure regulatory compliance by assessing whether manufacturing and control procedures on site are in line with dossiers approved by Health Authorities
·  Provides regulatory expertise to site projects like the introduction of new products, process technologies and continuous improvement projects
·  Assessment of and decision on regulatory impact of product-related changes
·  Manage regulatory site activities for changes with regulatory impact by organization of site meetings and participation in global meetings
·  Support QA functions for implementation of changes by cross-functional communication of regulatory timelines and approval statuses worldwide
·  Create and maintain quality-related submission documents for drug products and
·  Support change management of transfer projects by providing regulatory expertise for available product dossiers
·  Coordinate and follow up submission-related regulatory requests following dossier variations or new registrations
·  Prepare with contribution of site experts answers to questions from Health Authorities
·  Collaborate in creation and maintenance of standard operation procedures with regulatory context
·  Contribute to and support continuous improvement of performance and efficiency of regulatory working processes
·  Act as interface to Global or Affiliate Regulatory Affairs for QA or Manufacturing functions of the site
·  Support preparation of inspections and audits and participate as subject matter expert in audits/inspections
·  Write CMC regulatory documents/dossiers ready for submission by transforming scientific content to consistent CMC language and optimized terminology in order to facilitate the management of future changes.
·  Support Marketing Authorizations worldwide (territory extensions, renewals, site registrations and transfers, new submissions) by providing CMC documents/dossiers and collecting GMP related documents from the site(s)
·  Apply and optimize the use of appropriate company software tools to manage all regulatory activities

Requirements

·  Ph.D or Master in a science/health field (eg, Chemistry, Pharmacy, Pharmacology, Biology, Biotechnology etc.) or equivalent
·  Technical pharmaceutical CMC experience (laboratory, manufacturing, analytical control etc.) is desirable
·  Typically, 1-5 years of direct Regulatory CMC experience is preferred
·  Skills for handling of internal data management systems and documentation tools
·  Knowledge of both Chemical and Biological products is a plus
·  Knowledge of global regulations/guidelines and key Health Authority and Industry trends
·  Capability of strategic thinking for resolving technical and regulatory issues
·  Demonstrate initiative, independent thinking, anticipatory foresight, and ability to communicate effectively to internal and external audiences
·  Ability to make decisions in a highly moving environment
·  Fluency (oral and written) in English language is strongly recommended

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.

                      

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.