Regulatory Affairs Officer 633

4 days ago

Remote, India ProductLife Group Full time

Responsibilities

In the context of a project for one of our top Pharma client, we’re looking for 2 talented Regulatory Affairs Officer to lead the following missions, and much more

Compile, or supervise the compilation of regulatory dossiers
Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
Provide regulatory support to clients and associate companies
Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling
Review tasks for, support and mentor Regulatory Affairs Associates
Profile
UK and IE lifecycle maintenance experience
Providing support during external and unannounced audits.
Responding to internal requests for technical and/or regulatory information.
Preparation and submission of Technical/Site Transfer Applications
Assisting with the preparation of UK and IE Marketing Authorisation Applications
Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
Ensuring compliance with the regulations of the MHRA and HPRA
Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva (or comparable EDMS), LorenZ, Trackwise etc
A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
General regulatory administration duties and compliance requirements
Experience of promotional/non-promotional activities would be an advantage
Experience of operating within the post-Brexit regulatory landscape in UK and IE
Good IT skills/knowledge
Good organisational skills
Good communication skills
Pro-active attitude and able to work on own initiative as well as part of a team
Ability to prioritise different workloads/multi-task

Personal responsibility for ensuring a high standard of work

**Job Types**: Full-time, Temporary, Contract

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