Global Regulatory Affairs Project Support (m/f)

Arbeitsort Raum Darmstadt
Berufsgruppe Life Sciences (Natur­wissen­schaften)
Arbeitszeit Vollzeit
Branche Chemie/Pharma/Kosmetik/Kunststoff
Veröffentlicht am 20.07.2016
Jetzt bewerben

adesta - Erfolg ist Einstellungssache

Als renommierte Personalberatung mit Qualitätsanspruch ist adesta für namhafte Unternehmen erster Ansprechpartner, wenn es um die Gewinnung qualifizierter Fach- und Führungskräfte geht.

On behalf of our client, a world-renowned pharmaceutical enterprise with headquarters in the Rhine Main area, we are looking for


Global Regulatory Affairs Project Support (m/f)

  • Assist in preparation and execution of global regulatory strategies
  • Manage the submission and approval of applications for clinical trials (WW), amendments, prior to Marketing application activities such as PIP, orphan designation etc.
  • Manage the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentation at different Regulatory milestones
  • Managing regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (under supervision of a TA Head or Regulatory Strategist)
  • Participate to the regulatory strategies for projects (under supervision of the Regulatory Strategist )
  • Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy and labeling) including CTAs
  • Degree in a Life Science or related discipline
  • Minimum of 5 years' industry experience of which at least 3 years' regulatory experience
  • Experience in preparation and submission of a full submission/or large variation/supplement in at least one ICH region through to authorization
  • Experience with regulatory agency interactions and preparation of documentation to support interactions
  • Experience in CTA requirements worldwide Knowledge of in­ter­na­tio­nal regulatory affairs  Experience with supporting a project with development activities in at least two regions Experience with maintenance of regulatory authorizations in at least one region
  • Advantageous: eCTDs experience
  • Excellent spoken and written English
  • Excellent written and spoken communication skills
  • Good interpersonal skills
  • Attention to details
  • Ability to work in teams
  • Contribution to Pharma business
  • Good organizational and planning skills
  • Ability to lead GRA subteams
Are you interested in this challenging interim job? Then please submit your English profile under specification of reference number 29-302-461. If you have any questions, please do not hesitate to contact Mr Jungclaus.


„Als diplomierte Lebensmitteltechnikerin hatte ich eine langjährige Berufserfahrung vorzuweisen, doch den pas­sen­den Job zu finden, war trotzdem nicht so einfach. Nach dem ersten Vor­stel­lungs­ge­spräch blieb ich mit meiner adesta-Beraterin in ständigem Kontakt. Es dauerte dann zwar noch einige Zeit, aber letztendlich konnte ich erfolgreich vermittelt werden.“

Anna Szabo