Submission Delivery Coordinator

One of our clients, an international company in the pharmaceutical industry currently requires a Submission Delivery Coordinator

Start: ASAP
Length: min. 6 months
Location: South of Brussels

FUNCTION DESCRIPTION:

Within the Global Regulatory Affairs Operations team, the Submission Delivery Coordinator will provide the following key services:

- the planning, coordination and/or preparation and follow-up of the renewal files registered via the national route in the countries assigned and of all market specific items supporting a regulatory submission to ensure the timely approval of regulatory submissions.These items include official documentation (CPP's, GMP Certificates,Manufacturing Authorisations ), samples (packaging samples, vaccine samples), statements, certificates etc. The required items vary from case to case (country-specific and specific to each registration type).To this end, the Submission Delivery Coordinator will efficiently communicate to and liaise with Local Operating Company's (LOC's, located world-wide) and other internal stakeholders.
- the tracking and electronic filing of administrative activities and official documents

KEY RESPONSIBILITIES:

* Accountability

The Submission Delivery Coordinator organises the preparation, submission and follow-up of the renewal files and/or of all items supporting a submission file (ie MSR's):

- Plans requests and follow-up to ensure all requests are addressed on time and/or in line with priorities.
- Respects the priorities, based on business and compliance considerations.
- Through continuous contact with the LOC's in the countries, ensure saccuracy of their requests and communicates timings of availability.
- Coordinates the preparation of the items in collaboration with other Regulatory Affairs teams, other internal departments (eg, Quality Assurance, Global Industrial Operations) and other sites involved in the manufacture.
- Monitors progress of file and or MSR's preparation and highlights possible issues/delays to project leads, delegates and/or LOC's.

* Complexity

- The role is complex and needs to identify and anticipate issues that may cause delays in providing documents to LOCs.
- Numerous stakeholders & numerous regions to be managed.
- Numerous different documents to be handled.
- Potential contact with the authorities.
- Maintaining close contacts with LOCs to ensure customer needs.
- To liaise within the company to ensure that the teams responsible for documents generation are well aware of the customer needs and will deliver them in due time.
- To liaise with external teams.
- To be aware of the regulatory needs of the clients Local Operating Companies (LOCs) to ensure that the client can maximally support the local vaccine business.

PREREQUISITES:

Specialised Knowledge and Experience

* min. Baccalaureate ("graduate") level
* A similar experience, or experience in the Regulatory Affairs environment is a plus
* Computer proficient
* Strengths must include planning and organization
* Good team spirit (communication and collaboration)
* English and French speaking - additional language can be a plus (worldwide interaction)
* Experience with document management systems is suitable
* Ability to develop relationships based upon trust and mutual respect
* Ability to develop credibility with colleagues

Tags: Regulatory, submission, files, regulatory affairs, affaires réglementaires, LOC, soumissions, pharmaceutical, pharmaceutique