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Job Details

Regulatory Affairs Officer 2 - CMC Specialist

Company: Quintiles
Location: Reading
Reference: 1717821
Closing Date: 14 Nov 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

As a CMC specialist you could be looking to broaden your therapeutic, geographic or study exposure. Or perhaps you are looking a brighter future within Reg Affairs with our selection of development opportunities. At QuintilesIMS, you will get training and development to plan and progress your career in the direction you choose; we do believe there is not a ‘career ceiling. ...

Requirements:

As a CMC specialist you could be looking to broaden your therapeutic, geographic or study exposure. Or perhaps you are looking a brighter future within Reg Affairs with our selection of development opportunities. At QuintilesIMS, you will get training and development to plan and progress your career in the direction you choose; we do believe there is not a ‘career ceiling.

AS PART OF YOUR RESPONSIBILITIES, YOU WILL:

-  Act as CMC lead/specialist for client projects, may have CMC responsibility for a portfolio of products.

-  Conduct CMC change control assessments and provide regulatory strategy of CMC submissions worldwide

-  Author and review Module 3 sections and CMC documentation required to support submissions e.g IMPD updates, MAA, post approval variations and renewals.

-  Manage own work load, track project timelines, implement client requests and handle day-to-day workload in collaboration with senior staff, as appropriate.

-  Participate in project teams with internal and external customers independently and communicates confidently in straightforward matters

-  May prepare and deliver training, as appropriate.

-  Performs other tasks or assignments, as delegated by Regulatory management.

TO MEET OUR NEEDS, YOU WILL HAVE:

Technical Skills

-  Deep knowledge of variations/renewals/procedures in Europe and/or emerging markets and very thorough understanding of the content and typical level of detail in Module 3.

-  Conducted CMC Change Control Assessment – decide if regulatory action is required and if so figure out strategy, documentation requirements and timelines;

-  Preparation of technical justifications to support variations – prepared in cooperation with technical experts

-  Handled cross functional interactions with supervision to support CMC activities;

-  Prepare and review Module 3 CTD sections for regulatory submissions (variations, renewals, responses to RA assessments);

-  Experience of product development/manufacturing or analytical work is strongly preferred

Soft Skills

-  Ability to handle own workload and to work to tight timelines

-  Adaptable to change

-  Excellent verbal and written presentation skills and computer skills e.g. Word, Excel

-  Experience of using document management and change control systems

-  Demonstrate cultural awareness

-  Project management experience an advantage

MINIMUM EDUCATION AND CERTIFICATION(S)

You should have Bachelor of Science Degree in life science related discipline and minimum 2 years regulatory CMC experience, focusing on marketed products in Europe and/or emerging markets

Apply for this job: Regulatory Affairs Officer 2 - CMC Specialist

Contact Information:

Address:  .
.

England
Website:  Visit Our Web Site

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