* Manage and enhance protocols for sharing relevant dossier parts with third parties.
* Examine deviations that may have an influence on registered details and confirm dossier
conformity.
* Provide guidelines on assessing the regulatory compliance implications of QMS procedures.
* Respond to requests to improve quality from partners/customers and international health
authorities (FDA, EMA, ...)
* Serve as a subject matter expert on dossier content and train the team.
* Cross-functional quality leadership and experience in technical and business problems are
required.
* Support electronic quality systems by collaborating with the digital team.
* Lead programs that promote regulatory compliance and continual improvement.
* Participate in external committees to have an impact on the industry
Requirements:
* Bachelor's degree or higher, preferably in Sciences or Engineering.
* 20+ years of experience in Regulatory Compliance or equivalent functions in GxP-regulated
Pharmaceutical Industry
* Experience in communicating and working in close contact with FDA, EMA and other
authorities
* Desire to build out a new function in an agile way with flat hierarchies
* Proven track record in management of regulatory dossier compliance reviews and solution-
oriented handling of complex regulatory impacting Change Controls and Deviations.
* Strong proven leadership experience
* Ability to manage stakeholders at all levels and achieve in a matrix organisation.
* Proficient in English, additional languages are a plus.
* Proactive team player with strong interaction skills who will flourish in a dynamic environment.
* Travel up to 20%
