Regulatory Manager- Retro Compliance

Job Summary:

Contract Role - 9 Months - Regulatory Manager- Retro Compliance
Requirements:

Title: Regulatory Manager - Retro Compliance

Location: London

Main Purpose of role

Part of the team to deliver the on going, high priority MA Compliance project

KEY RESPONSIBILITIES:

Be part of the team working solely on the Client Retro compliance project
Perform detailed gap analysis of designated products
Liaise with the team and project lead to agree required actions
Execute and follow up on the agreed actions (often variations)
Work within the agreed processes, SOPs and timeframes set for the project as a whole and on an individual basis.
Achieve and maintain excellent cross functional working
Collaborate across the unit when required to achieve operational effectiveness
Ensure timely delivery of compliance dossiers using regulatory document management system and publishing tools as appropriate
100% accurate and complete review and approval of Change Control Forms for changes relating to technical information

PERFORMANCE STANDARDS:

Local and global regulatory and legal standards
High standard of documentation throughout the workflow process
High degree of accuracy in all tasks

Qualifications:

Life science degree
Relevant regulatory affairs training (can be mainly internal)

Experience & Competences

Regulatory affairs and technical experience : at least 3 years
Competency in documentation systems including EDMS or similar

Knowledge & Skills

Good working knowledge of the current Retro Compliance project or related / similar projects
Knowledge of MS Word, Excel, Adobe Acrobat, power point and Documentum.
Knowledge of European Regulations, Guidelines and Application Procedures
Experience with Common Technical Document components and Quality Overall Summaries
Knowledge of European Regulations, Guidelines and Application Procedures
Experience of technical aspects of product manufacture

Personal Qualities

Excellent communication skills, results driven, customer focus at all times, team player
Focus on attention to detail and quality/accuracy

NOTE: I am a senior recruiter within the industry across a number of job divisions for the pharmaceutical, biotech and CRO sectors. For a confidential and professional chat about your requirements/ career advice and the chance to register for free and receive weekly job updates, please call Alex on or email

If this role is not what you are looking for and you have experience in or are looking to enter the pharmaceutical, pharmacy, biochemical or other scientific fields, please still contact us anyway because listed here on Pharmiweb are only a selection of the many vacancies we have available.

Keywords:

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