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Regulatory Operations Specialist - 3 Months Contract
About Our Client
Our client is an international bio pharmaceutical company who is reinforcing its Regulatory Operations.
- Ensure support to the Regulatory Liaison team (EMEA and Global) for proactive interactions with other functions, contract research organizations, partner companies, and health authorities.
- Ensure tracking of reporting obligations in the RIMS system and proactively inform the Regulatory Liaison team of upcoming submissions.
- Plan and lead with Regulatory Liaison the preparation, review, and approval of compliant documents for regulatory submissions throughout the product life cycle.
- Manage the electronic publishing of regulatory submission documents according to ICH, Competent Authority and company defined standard (CTA, MAA, eCTD) in compliance with technical validation requirements and in accordance with agreed timelines for regulatory submissions in the assigned regions.
- Coordination of packaging and labelling activities between Regulatory Affairs, Regulatory Consultants and Supply Chain.
- Artwork QC of packaging proofs/mock-ups vs Product Information.
- Contribute positively to a strong culture of business integrity and ethic's.
- Act within compliance and legal requirements as well as within company guideline.
The Successful Applicant
- Use of Microsoft Office and project management experience.
- Minimum of 3 years pharmaceutical regulatory operations experience of pharmaceutical regulatory operations with use of eCTA software and Adobe Acrobat desktop publishing.
- Experience industry standard DMS.
- Experience with publishing clinical trails applications and eCTD MAA lifecycle submissions.
What's on Offer
We are looking for someone who could quickly come on board and be operational/ autonomous.