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Job Details

Senior Regulatory Affairs Officer - LCM

Company: IQVIA
Location:
Reference: R1051520
Closing Date: 28 Jan 19
Type: Full Time
Salary (£): Competitive
Benefits: Competitive package

Job Summary:

A career at IQVIA™ as a SENIOR REGULATORY AFFAIRS OFFICER will connect you to great opportunity to achieve professional success. At IQVIA™ your work will also impact healthcare around the world as you will be involved with the most important drugs and the highest-profile clients. With clear career paths, a supportive working environment and a flexible working culture, our employees are empowered to drive their careers forwards to match their goals.

Requirements:

Technical Skills/Experience

Degree in life science-related discipline or professional equivalent

Minimum of 5 years in international regulatory lifecycle maintenance experience, focusing on marketed products

Experience in regulatory procedures in Europe and/or emerging markets (e.g. variations/renewals/new MAA submissions)
to support marketing authorisation activities

Good understanding of pharmacovigilance activities relevant to marketed products

Experience in managing regulatory projects

Interaction with Regulatory Agencies (EU/EMA)

Involvement in regulatory strategy and determination of documentation requirements, timelines, budgets

Preparation of relevant CTD documents to support submissions (mainly Module 1), in collaboration with technical/CMC/Labelling experts

Experience in quality review of technical/ regulatory documents

Able to mentor junior colleagues and to assist in their training and development as appropriate

Able to assist in review and revision of regulatory SOPs / act as reviewer as appropriate

 

Soft Skills

Excellent verbal and written communication skills, proficient English skills are essential

Be able to manage peaks of workload and prioritise workload with minimal supervision

Ability to work to tight timelines

Open and communicative personality

Good team player

Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach

Strong computer skills, including MS Office applications, data and document management systems

Adaptable to change

Cultural awareness

Apply for this job: Senior Regulatory Affairs Officer - LCM

Contact Information:

Address:  Reading Office
500 Brook Drive Green Park Reading Berkshire
RG2 6UU
England
Tel:  +44 (0) 1184 508000
Website:  Visit Our Web Site

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