Regulatory Affairs Consultant (CMC/procedure lifecycle management/Life sciences) - Remote - 6 month
Posted on Sep 24, 2021 by Octopus Computer Associates
Regulatory Affairs Consultant (CMC/procedure life cycle management/Life sciences) - Remote - 6 months
One of our Blue Chip Clients is urgently looking for a Regulatory Affairs Consultant.
For this role you can work fully remotely.
Please find some details below:
Job description summary
Coordinate and manage the content of relevant technical/CMC sections of product specific documents, 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 (Pre/Post publishing dossier review).
- 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 (Cover Letter, eAF, Present/Proposed).
- Ensure efficient interactions and alignment with stakeholders and teams (RA CMC, writers, contributive disciplines,..) on submission strategy.
- Ensure planning and proper organisation of activities (for technical/CMC and procedural aspects) in line with the overall project plan and RA milestones.
- Support on change control assessment."
- Pro-active, reactive, flexible and go getter.
- Good understanding of regulatory environment.
- Good time management and organizational skills. "
"Significant experience in regulatory affairs (CMC/procedure life cycle management).
Relevant scientific and technical background in Life Sciences or related field."
Please send CV for full details and immediate interviews. We are a preferred supplier to the client.