Senior Regulatory Affairs Officer - CMC
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
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
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
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
Project management experience