Global Regulatory Affairs Project Support (m/f)

Arbeitsort Raum Darmstadt
Berufsgruppe Life Sciences (Natur­wissen­schaften)
Branche Chemie/Pharma/Kosmetik/Kunststoff
Veröffentlicht am 30.10.2017
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.

„My experience with adesta was a pleasant and rewarding one. I had excellent service during the recruitment process, with the Senior Consultant helping me to prepare me for my interview. There was effective communication and the team was approachable and committed.“

Christine Nkemngu

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