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Job Details

Regulatory Affairs Officer II - LCM

Company: IQVIA
Location:
Reference: R1051517
Closing Date: 28 Jan 19
Type: Full Time
Salary (£): Competitive
Benefits: Competitive package

Job Summary:

As REGULATOR AFFAIRS OFFICER II - CMC you will be expected to prepare and/or reviews regulatory submissions to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. 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.

Requirements:

RESPONSIBILITIES

Acts as a Regulatory Team member involved in projects, under the guidance of senior staff.

Manages day-to-day workload in collaboration with senior staff, as appropriate.

Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.

Actively participates with internal and external customers and communicates confidently in straightforward matters.

Understands the Scope of Work, and deliverables for a given project.

May prepare slides and background material for meetings under senior guidance and present to clients by phone or in person.

Preparation of submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, CMC authoring and \ or updates as required.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Technical Skills/Experience

4-5 years regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)

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

Quality review of technical/ regulatory documents

Interaction with Regulatory Agencies (EU and/or National Agency)

Regulatory strategy and determination of documentation requirements, timelines, budgets

Revision/review of regulatory SOPs, as appropriate

Project management experience - an advantage

Broad experience in preparing international dossiers including APAC regulatory requirements.

Soft Skills

Ability to work to tight timelines and manage peaks in workload

Good team player

Good negotiating skills and the ability to identify and resolve issues

Excellent verbal and written communication skills

Excellent computer skills e.g. Word, Excel, data and document management systems

Cultural awareness for global ways of working

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

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

•     Degree in life science-related discipline or professional equivalent plus at least 5 year’s relevant experience*  

        (*or combination of education, training and experience)

5 years regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions.

Apply for this job: Regulatory Affairs Officer II - 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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