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Technical Regulatory Writer - Compliance Belgium,
Keyrus Biopharma (company)
Posted on : 24 June 2017
We are looking for a medior Technical Regulatory Writer for Compliance for one of our clients.
The Technical compliance regulatory writer is involved in the company s regulatory activities related to Compliance projects, on a domestic or international basis.
Role and main tasks:
- Writing CMC parts of regulatory life cycle variations/supplement for all destinations
- Writing Module 2 of regulatory files derived from completed eCTD Modules 3
- Writing Responses to Questions raised by Regulatory Authorities on CMC matters
- Support to transversal Regulatory CMC activities
University level (Life Sciences background is preferred)
- Knowledge of regulatory procedures / systems / guidances
- Knowledge of Qualification / Validation principles.
- Knowledge of Change Control process
- Knowledge of cGMP
- Knowledge of biological products and process equipment.
- Experience is writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
- Experience working with Biologics (if possible preferred over Pharmaceuticals)
- Manages own time to meet agreed short-term targets. Ability to clearly identify prioties and manage multiple tasks
- Good communication skills
- Writing skills
- Analytical skills, creative and critical mind
- Team player
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization &).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our human approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.
Walloon Brabant Belgium
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