Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Regulatory Affairs Coordinator
Eingestellt von Clearsource
Gesuchte Skills: Support, Marketing
Projektbeschreibung
For one of my best clients I am actively looking for a Regulatory Affairs Coordinator for a challenging opportunity in a communicative company leader in its market.
START: ASAP
DURATION: 1 year ( +extension)
LOCATION: Brussels
DESCRIPTION:
As a Regulatory Affairs Coordinator you will be in charge of the following tasks:
Primary activities of EMEA Regulatory Coordinator:
- To provide procedural, administrative and planning support for new submissions and variation submissions in the EU, Switzerland and the non-EU CES countries for products approved through the Centralized, Mutual Recognition and Decentralized procedures
- To provide administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements
- To plan and coordinate new submissions, variations, CHMP referrals, FUM, in order to ensure timely submission
- To draft module 1 components and to organize the gathering of the module 1 components
- To collaborate closely with Regulatory Operations to establish submission timelines and content of Module 1
- To collaborate closely with subsidiary Registration Managers in order to ensure timely submission
- To prepare the English Product Information (SmPC, label and leaflet) in collaboration with WPL
- For the centralized procedure: to supervise and coordinate the translation process to ensure timely submission to EMA
- To provide other administrative support related to Marketing Authorization Applications to Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed
- To ensure updates to regulatory databases
- To keep up to date with EU procedural requirements and legislation
- To participate as Subject Matter Expert in relevant work streams/projects as deemed appropriate by Regulatory Affairs Europe Senior Staff
- To lead regional submission cross-portfolio planning team meetings; agenda, decisions, action items
- To act as the regional point of contact (on status of regional regulatory milestones) for Business Owners
- To assist Business Owner in resolution of issues identified with acceleration or delay of regulatory milestones
- To interact as necessary with regional MMD planning and/or manufacturing sites regarding issues
SKILLS:
- University degree or similar (such as A1 in Belgium),
- Preferably at least two years of experience in the pharmaceutical industry with knowledge about regulatory affairs
- Experience with project management is an asset
- Good understanding of the end-to-end pharmaceutical life cycle
- Excellent written and verbal English is a must; other European languages are an asset
Interested? Please send me your CV immediately
START: ASAP
DURATION: 1 year ( +extension)
LOCATION: Brussels
DESCRIPTION:
As a Regulatory Affairs Coordinator you will be in charge of the following tasks:
Primary activities of EMEA Regulatory Coordinator:
- To provide procedural, administrative and planning support for new submissions and variation submissions in the EU, Switzerland and the non-EU CES countries for products approved through the Centralized, Mutual Recognition and Decentralized procedures
- To provide administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements
- To plan and coordinate new submissions, variations, CHMP referrals, FUM, in order to ensure timely submission
- To draft module 1 components and to organize the gathering of the module 1 components
- To collaborate closely with Regulatory Operations to establish submission timelines and content of Module 1
- To collaborate closely with subsidiary Registration Managers in order to ensure timely submission
- To prepare the English Product Information (SmPC, label and leaflet) in collaboration with WPL
- For the centralized procedure: to supervise and coordinate the translation process to ensure timely submission to EMA
- To provide other administrative support related to Marketing Authorization Applications to Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed
- To ensure updates to regulatory databases
- To keep up to date with EU procedural requirements and legislation
- To participate as Subject Matter Expert in relevant work streams/projects as deemed appropriate by Regulatory Affairs Europe Senior Staff
- To lead regional submission cross-portfolio planning team meetings; agenda, decisions, action items
- To act as the regional point of contact (on status of regional regulatory milestones) for Business Owners
- To assist Business Owner in resolution of issues identified with acceleration or delay of regulatory milestones
- To interact as necessary with regional MMD planning and/or manufacturing sites regarding issues
SKILLS:
- University degree or similar (such as A1 in Belgium),
- Preferably at least two years of experience in the pharmaceutical industry with knowledge about regulatory affairs
- Experience with project management is an asset
- Good understanding of the end-to-end pharmaceutical life cycle
- Excellent written and verbal English is a must; other European languages are an asset
Interested? Please send me your CV immediately
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Marketing/Vertrieb, Sonstiges