Senior Regulatory Affairs Officer - CMC

28 Nov 2018
28 Jan 2019


Acts as CMC lead/specialist for client projects, will have CMC responsibility for a portfolio of products.

Conducts CMC change control assessments

Provides regulatory strategy of CMC submissions worldwide

Authors and reviews Module 3 sections

Prepares and reviews CMC documentation required to support submissions e.g. IMPD updates, MAA, post approval variations and renewals.

Manage own work load, tracks project timelines, implements client requests and manages day-to-day workload.

Actively participates 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.

Acts as mentor to junior colleagues

May act as Project Manager/CMC RA Lead on projects



Technical Skills

Bachelor of Science Degree in life science related discipline

Minimum 4 years regulatory CMC experience, focusing on marketed products in Europe and/or emerging markets

Knowledge of variations/renewals/procedures in Europe and/or emerging markets

Complete understanding of the content and typical level of detail in Module 3.

Conducted CMC Change Control Assessment – determine if regulatory action is required and if so determine the strategy, documentation requirements and timelines;

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

Manage cross functional interactions to support CMC activities;

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

Project Management of small to medium size projects

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

Soft Skills

Be able to manage own workload

Ability to work to tight timelines

Adaptable to change

Excellent verbal and written communication skills

Excellent computer skills e.g. Word, Excel

Experience of using document management and change control systems

Good team player

Cultural awareness

Project management experience

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