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Regulatory Affairs - Technical Regulatory Writer - Belgium
Keyrus Biopharma (company)
Posted on : 23 May 2017
- We are looking for a senior Technical writer CMC for one of our clients.
- The technical Regulatory Writer is involved in the company's regulatory activities related to new and existing products, on domestic or international basis.
Primary Tasks & Responsibilities:
- Writing CMC parts of regulatory variations
- Writing Module 2 of regulatory files derived from completed eCTD Modules 3
- Writing IMPDs as far as CMC information is concerned
- Writing Responses to Questions raised by Regulatory Authorities on CMC matters
- Update of internal tracking system linked to their CMC activities
- Involvement in internal initiatives for improvement of processes/ ways of working
- Scientific university degree
- Experience inwriting CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
- Knowledge of regulatory procedures / systems / guidances
- Experience working with Biologics (if possible preferred over Pharmaceuticals)
- Knowledge of the EU/US variations policy
- Experience in a research laboratory or in regulatory/drug development/public health organization
Soft skills :
- Manages own time to meet agreed short-term targets
- Ensures the coherence between contributions / quality of final results
- Team player
ICT skills :
- Microsoft Office (Word, Excel, PowerPoint)
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.