Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

-Prepares, reviews and coordinates local regulatory submissions and strategies (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.

•-Technical expertise and coordination oversight for projects in collaboration with relevant internal

departments.

• Serves as primary contact for investigators and with the local regulatory

authorities (in collaboration with the local regulatory manager for complex

issues) to ensure submissions are managed in a timely manner.

• Ensures guidelines and processes are followed for effective internal PPD team

communications as well as communications with investigators, and with the

country regulatory authorities to ensure submissions are managed in a timely

manner.

• Acts as a key-contact at country level for all submission-related activities.

• Participates as required in Submission Team Meetings, Review Meetings and

Project Team meetings.

• Coordinates 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 PPD’s target cycle times for site activations.

• Works with the start-up CRA(s) to prepare the regulatory compliance review

packages, as applicable.

• Assists in identifying and recognizing local out of scope activities in a contract in

a timely manner and advise relevant functions.

• Supports the coordination of feasibility activities, as required, in accordance with

agreed timelines.

• Oversees country study files and ensures that that they meet PPD WPD’s or

client SOP’s.

• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Directs/mentors other SIA individuals assigned to support projects of responsibility, as appropriate.

Prepares and maintains country master document templates and other PPD

regulatory intelligence systems, as may be required and assigned.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.