Keyrus Life Science is looking on a regular basis for Technical Regulatory CMC Writers to join our consulting team for clients (from big pharma to small biotech) based in Belgium.
This job description is an example on how your job could look like. Once we have a specific project and client you will be informed and you will have of course the choice to be presented at our client.
Your potential challenges could be:
- The Technical Regulatory Writer is involved in the company’s regulatory activities related to new & existing products,
on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions....
- Write CMC, “facility and equipment” parts and new files for WW regulatory File.
- Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion.
- Ensure the coordination with the departments involved in the writing/review process
- Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities
- Monitor that supportive data provided by other departments are compliant.
- Report significant issues
- Manage the projects within all company/GRA tracking tools
- Assess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities.
- University level (Life Sciences background is preferred) or equivalent by experience.
- At least 3 years of experience in writing CMC (technical) parts of regulatory documents (registration files or variations).
- Experience working in validation/QA/production in Biologics/Pharmaceuticals industry
- Knowledge of regulatory procedures / systems / guidance
- Good level of spoken and written English
- Knowledge of biologic process and process equipment.
- Knowledge of Qualification / Validation principles.
- Manages own time to meet agreed short-term targets
- Good communication skills
- Writing skills
- Analytical skills, creative and critical mind
- Ensures the coherence between contributions / quality of final results
- Team player
What we offer
Joining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.
As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, fuel card, meal vouchers, group insurance, hospitalization…) based on your background and experience.
Who we are
Keyrus Life Science 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.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skilfully, 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, Biostatistics, Medical Writing & Medical Information, Real World evidence services.