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Regulatory Affairs Assistant BE LUX
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Marketing
Projektbeschreibung
One of our clients, a multinational company in the pharmaceutical industry currently requires a Regulatory Affairs Assistant with experience in the Belgian and Luxembourgish market
Start: ASAP
Length: min 9 months
Location: South of Brussels
Regulatory Affairs Assistant Belgium and Luxembourg
FUNCTION DESCRIPTION:
Description:
The Regulatory Affairs Assistant is responsible for preparing and submitting regulatory dossiers (initial marketing authorisations applications, variations, commitments, PSURs, answers to questions, renewals) to the Belgian Federal Agency for Health and Medicinal Products and tothe Luxemburgish Ministry of Health in accordance with the legislation.
The Regulatory Affairs Assistant is also responsible for following upwith these Regulatory Authorities up to the approval.
The timely approval of changes are key to ensure continuity of vaccine supply, not only on the Belgian and Luxembourg markets, but also on allmarkets outside Europe relying on the Belgian (source-country) regulatory approvals.
KEY RESPONSIBILITIES:
* In line with legal requirements, prepares the submissions of regulatory dossiers specific to Belgium and Luxembourg based on the generic data packages provided by the Regulatory Affairs Project teams.
* Ensures that regulatory dossiers are submitted in due time to the Belgian and Luxemburgish Regulatory Authorities via the Common European Submission Platform, and are successfully validated.
* Ensures that the financial obligations relative to each submissionare met.
* Is responsible for handling the administrative steps to allow final administrative approval of variations and renewals leading to theissuing of updated marketing authorisations.
* Is responsible for internal communication of regulatory approvals andappropriate tracking in databases.
* Ensures that the official communications with the Regulatory Authorities and the updated marketing authorisation are stored in appropriate databases.
* Communicates with the Belgian and Luxemburgish Regulatory Authoritiesas appropriate, as well as with Project teams and with the Local Operating Company developing the Prescribing Information artworks for vaccines.
PREREQUISITES:
Education:
- Baccalaureate ("graduate") level
Knowledge/Experience:
- Experience in working in the Regulatory Affairs environment
- A similar experience in working with the Belgian and Luxemburgish Regulatory Authorities is a plus
- Good level of spoken and written English and French
- Ability to develop relationships based upon trust and mutual respect
Skills:
- Excellent organizational and planning skills to meet agreed short-term deadlines
- Flexible and sense of urgency
- Analytical and detail oriented
- Use of databases
- Customer oriented and good team player
- Autonomous
- Good communication skills
- English and French (oral and written)
Tags: Regulatory, Règlementaires, Belgium, Luxembourg
Start: ASAP
Length: min 9 months
Location: South of Brussels
Regulatory Affairs Assistant Belgium and Luxembourg
FUNCTION DESCRIPTION:
Description:
The Regulatory Affairs Assistant is responsible for preparing and submitting regulatory dossiers (initial marketing authorisations applications, variations, commitments, PSURs, answers to questions, renewals) to the Belgian Federal Agency for Health and Medicinal Products and tothe Luxemburgish Ministry of Health in accordance with the legislation.
The Regulatory Affairs Assistant is also responsible for following upwith these Regulatory Authorities up to the approval.
The timely approval of changes are key to ensure continuity of vaccine supply, not only on the Belgian and Luxembourg markets, but also on allmarkets outside Europe relying on the Belgian (source-country) regulatory approvals.
KEY RESPONSIBILITIES:
* In line with legal requirements, prepares the submissions of regulatory dossiers specific to Belgium and Luxembourg based on the generic data packages provided by the Regulatory Affairs Project teams.
* Ensures that regulatory dossiers are submitted in due time to the Belgian and Luxemburgish Regulatory Authorities via the Common European Submission Platform, and are successfully validated.
* Ensures that the financial obligations relative to each submissionare met.
* Is responsible for handling the administrative steps to allow final administrative approval of variations and renewals leading to theissuing of updated marketing authorisations.
* Is responsible for internal communication of regulatory approvals andappropriate tracking in databases.
* Ensures that the official communications with the Regulatory Authorities and the updated marketing authorisation are stored in appropriate databases.
* Communicates with the Belgian and Luxemburgish Regulatory Authoritiesas appropriate, as well as with Project teams and with the Local Operating Company developing the Prescribing Information artworks for vaccines.
PREREQUISITES:
Education:
- Baccalaureate ("graduate") level
Knowledge/Experience:
- Experience in working in the Regulatory Affairs environment
- A similar experience in working with the Belgian and Luxemburgish Regulatory Authorities is a plus
- Good level of spoken and written English and French
- Ability to develop relationships based upon trust and mutual respect
Skills:
- Excellent organizational and planning skills to meet agreed short-term deadlines
- Flexible and sense of urgency
- Analytical and detail oriented
- Use of databases
- Customer oriented and good team player
- Autonomous
- Good communication skills
- English and French (oral and written)
Tags: Regulatory, Règlementaires, Belgium, Luxembourg
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Marketing/Vertrieb