Regulatory Affairs Europe, Associate Liaison
Il y a 6 mois
For our site in Brussels, we are looking for a Regulatory Affairs Europe, Associate Liaison
Primary Activities:
- Provides administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements.
- Plans and coordinates new submissions, variations, CHMP referrals, FUM. to ensure timely submission.
- Drafts of module 1 components and organizing the gathering of the module 1 components.
- Collaborates closely with Regulatory Operations to establish submission timelines and content of Module 1.
- Collaborates closely with Country RA Registration Managers in order to ensure timely submission.
- For the centralized procedure, supervises and coordinates the translation process to ensure timely submission to EMA.
- Provides other administrative support related to Marketing Authorization Applications to the Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed.
- Ensures updates to regulatory databases.
- Keeps up to date with EU procedural requirements and legislation.
- Participates as SME in relevant workstreams/projects as deemed appropriate by Regulatory Affairs Europe Senior Staff.
Education/skills
- University degree (or similar such as A1 in Belgium), preferably in a science related to medicine, and at least four years of experience in the pharmaceutical industry with knowledge of the drug development and/or approval process.
- Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English.
- Can work across boundaries, demonstrates the ability to act as intermediary across boundaries.
- Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
- Demonstrates ability to coordinate tasks with others for timely completion and to avoid setbacks.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R255967
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