- You coordinate and lead CMC and Compliance regulatory activities for concerned molecules of specific focus area (life cycle management).
- You are accountable and responsible for translation and interpretation of country regulatory requirements into CMC/Technical requirements to provide prospective advice to the interdisciplinary CMC team as well as identifying potential pharmaceutical issues and risks, contribute to risk mitigation and solution of issues in close collaboration with corresponding functions. You will participate in Change Control Procedures according to the current pharmaceutical requirements and systems and processes for CMC Dossier approvals.
- You should ensure CMC Reg Compliance for products handled in the group. Responsible for the creation of the quality reference files for products handled in the group and you will be responsible for performance/preparation of regulatory compliance audits/inspections at the sites including CMOs.
- You are responsible for commenting, interpretation and implementation of CMC relevant laws, directives, guidelines and pharmacopeias.
- You have a University Degree in Life Sciences
- Expert assessment of in-and out licensing projects for business development (Due Diligence)
- You have specific experience in the field of marketing authorizations, ICH and GMP guidelines, Document Management Systems
- Profound expertise in pharmaceutical legislation and application of current regulatory landscape including pharmacopeia requirements for the pharmaceutical areas
- Document Management Systems > 5 yrs.
- Experience in the field of marketing authorizations > 5 yrs.
- ICH and GMP guidelines > 5 yrs.
- Pharmaceutical legislation and application of current regulatory landscape > 5 yrs.
- You have excellent communication skills and fluent in spoken and written English
Standort: Darmstadt & Remote
Projektlaufzeit: 480 Tage bis 01.06.2020
Verfügbarkeit: 4-5 Tage/Woche