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Regulatory Affairs Consultant (CMC/procedure lifecycle management/Life sciences) - Remote - 6 month

Octopus Computer Associates

Posted on Sep 24, 2021 by Octopus Computer Associates

Not Specified, Belgium
IT
Immediate Start
Annual Salary
Contract/Project


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.

Responsibilities

- 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."

IT-Skills

Microsoft office

Soft-Skills

- Pro-active, reactive, flexible and go getter.

- Good understanding of regulatory environment.

- Good time management and organizational skills. "

Other specifics

"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.




Reference: 1333116010

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