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Job Details

Regulatory Consultant- FMD 3 Days a week

Company: SRG Clinical
Location: Uxbridge
Reference: J27079
Closing Date: 10 Jul 18
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a part time Regulatory Affairs Consultant with experience dealing with EU FMD to be based at their offices in West London.

Requirements:

Responsibilities
- Review of the status of National Medicines Verification organisation (NMVO) and support if necessary for the on-boarding / registration process.
- Follow-up and interpretation of national and European notes, local news related to Serialization readiness.
- Support other departments involved in the project on clarification on specific technical queries (e.g. labelling, anti-tampering device, National and Global trade identification numbers (NTIN/GTIN) requirements, batch and expiry date prefixes, marking requirements)
- To review and update accordingly the list of products affected by the EU Falsified Medicines Directive (FMD)
- Follow up of “Regulatory readiness” for serialization (QRD changes)
- Review and confirmation of NTINs with local Regulatory colleagues

Experience / Qualifications
- Extensive hands on experience within Regulatory affairs
- Knowledge / understanding of the EU FMD (EU Falsified Medicines Directive)
- Capacity of interpret the regulation (Delegated Act / Q&A document)
- Be able to contact and work with each one of the RA country representatives to ensure that local requirements in terms of Serialization are well addressed
- Be able to contact with local Competent Authorities (HA, EU/National Medicines Verification organisations.) for specific queries or support the Local RA Managers to do so
- Capability for multi-country follow-up in terms of Serialization local requirements
- Basic knowledge / understanding of manufacturing / packaging operations

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

Apply for this job: Regulatory Consultant- FMD 3 Days a week

Contact Information:

Address:  Head Office
SRG Clinical 9 Devonshire Square London United Kingdom
EC2M 4HP
England
Tel:  +44 (0)203 096 4700
Website:  Visit Our Web Site

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