EXPERIENCE & EDUCATION

• Technical pharmaceutical CMC experience (laboratory, manufacturing, analytical control etc.) is desirable
• Several years of direct Regulatory CMC experience is preferred
• Knowledge of global regulations/guidelines and key Health Authority and Industry trends of advantage
• Ph.D or Master in a science/health field (e.g. Chemistry, Pharmacy, Pharmacology, Biology, Biotechnology etc.) or equivalent (not mandatory)

SOFT SKILLS

• 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.

TECHNICAL SKILLS

• Knowledge of both Chemical and Biological products is a plus
• Skills for handling of internal data management systems and documentation tools

• Ensure regulatory compliance by assessing whether manufacturing and control procedures on site are in line with dossiers approved by Health Authorities
• 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
• Provides regulatory expertise to site projects like the introduction of new products, process technologies and continuous improvement projects
• Support change management of transfer projects by providing regulatory expertise for available product dossiers
• Write CMC regulatory documents/dossiers ready for submission by transforming scientific content to consistent CMC language and optimized terminology 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)
• 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
• Act as interface to Global or Affiliate Regulatory Affairs for QA or Manufacturing functions of the site
• 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
• Support preparation of inspections and audits and participate as subject matter expert in audits/inspections
• Apply and optimize the use of appropriate company software tools to manage all regulatory activities