Assist in preparation and execution of global regulatory strategies defined for three biosimilar projects in partnership with an external pharmaceutical company. Under the leadership of a TA Head coordinate regulatory activities between regulatory affiliates, reg. CMC and partner company with the view of submitting regulatory dossiers in specific geographies: USA, Europe, Brazil, Switzerland, and Australia.
Coordinate the regulatory activities performed by Merck in support of three projects including management and coordination of the preparation of all regulatory documentation at different regulatory milestones.
Support the partner regulatory function in coordinating Merck regulatory inputs and supportive activities.
Support transition of regulatory activities between Merck and Partner company.
When under Merck supervision, oversee of the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (under supervision of a TA Head).
Support Merck regulatory CMC participation to the CMC and Devices subteam.
Prepare and support Merck regulatory participation within clinical, safety and regulatory workstream.
- Several years of industry experience with regulatory experience > 5 yrs.
- Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA) > 5 yrs.
- Interest into Scientific details > 5 yrs.
- Knowledge of international regulatory affairs > 5 yrs.
- Prior exposure to Regulatory Affairs preferably in a global position > 5 yrs.
English – business fluent
Standort: Darmstadt & remote
Projektbeginn: August 2018
Projektlaufzeit: 70 Tage bis 31.12.2018
Verfügbarkeit: 20% on-site support, 80% remote