Technical Procedural Ra Consultant
il y a 3 semaines
At Capgemini Engineering we value excellence, care, responsibility, dynamism and innovation. We offer a job with variation that leaves plenty of room for initiative and development. In fact, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.
As a Technical Procedural RA Professional it is your mission to manage the content of relevant technical/CMC sections of product specific documents at our clients’ site, to ensure proper planning and execution of regulatory submission packages.
- Participate to discussions and provides in-depth strategic, scientific and RA input for technical/CMC and procedural aspects of given product.
- Provide input into the asset specific regulatory strategy on a global scale for technical/CMC and procedural aspects.
- Review of the technical and procedural section of regulatory documents
- Coordinate (for technical/CMC and procedural part) the determination of key messages for product specific regulatory documents to be submitted to Authorities
- Compile/write high quality product specific regulatory documents to be submitted to Authorities (for technical/CMC and procedural sections) and ensure that those documents meet regulatory requirements.
- Ensure efficient interactions with the regulatory authorities to achieve on-time approvals
- Ensure planning and proper organisation of activities (for technical/CMC and procedural aspects) in line with the overall project plan and RA milestones
- Significant experience in regulatory affairs (CMC/ procedure lifecycle management
- Relevant scientific and technical background in Life Sciences or related field
- Pro-active and go getter
- Good understanding of regulatory environment
- Good time management and organizational skills
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