Sr Ctry Approval Spec

Work Schedule

Environmental Conditions

Job Description

Prepares reviews and coordinates under guidance local regulatory submissions
(MoH EC additional special national local applications if applicable e.g. gene
therapy approvals viral safety dossiers import license) in alignment with global
submission strategy.
Provides under guidance local regulatory strategy advice (MoH &/or EC) to
internal clients.
Provides project specific local SIA services and coordination of these projects.
May have contact with investigators for submission related activities.
Key-contact at country level for either Ethical or Regulatory submission-relatedactivities.
Coordinates under guidance with internal functional departments to ensure
various site start-up activities are aligned with submissions activities and
mutually agreed upon timelines; ensures alignment of submission process for
sites and study are aligned to the critical path for site activation.
Achieves PPDs target cycle times for site.
May work with the start-up CRA(s) to prepare the regulatory compliance reviewpackages as applicable.
May develop country specific Patient Information Sheet/Informed Consent formdocuments.
May assist with grant budgets(s) and payment schedules negotiations with sites.
Supports the coordination of feasibility activities as required in accordance withagreed timelines.
Entes and maintains trial status information relating to SIA activities onto PPD
tracking databases in an accurate and timely manner.
Ensures the local country study files and filing processes are prepared set up
and maintained as per PPD WPDs or applicable client SOPs.
Maintains knowledge of and understand PPD SOPs Client SOPs/directives andcurrent regulatory guidelines as applicable to services provided.

Qualifications:
Education and Experience:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to5 years).
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to5 years).

Working Conditions and Environment:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear garments and gloves.