I am exclusively supportinga client who are currently looking for an experienced Regulatory Consultant to support the team with licensing activities to the EMA.
The successfulcandidate would provide appropriate regulatory guidance to Project Teams for the development of regulatory submissions and responsible for the overall quality of submissions; manages, reviews and organizes documents intended for submission to EMA to assure compliance with regulatory standards. This person would work with publishing as we as a Regulatory lead to ensure on-time submissions to the EMA and possibly other regions.
- Works closely with global and local colleagues to agree on regulatory data requirements.
- Critically evaluates submission packages in line with regulatory requirements in order to eliminate deficiencies prior to construction and submission of MA applications within agreed timeframes.
- Monitors and influences assessment process to expedite andoptimisethe outcome of their submissions.
- Ensure Communication of any regulatory changes to the business as necessary to support licence compliance
- Submission and maintenance of official local drug information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs, and their Educational Material.
- Assists senior RA team members with new MA submissions eg Scientific Advice meetings, attendance at launch meetings, pre-vetting materials, and stock readiness
- Contributes to the continuous process improvements and inspection readiness for both internal process reviews/audits and HA inspections for GxP.
If you are interested, then please apply or email directly at firstname.lastname@example.org
- Agency: Cpl Life Sciences
- Contact: Ed Taylor
- Reference: JO-2111-480948
Website: Cpl Life Sciences
- Posted: 25th November 2021
- Expires: 23rd December 2021