Regulatory Affairs Officer 2
Closing Date: 09 Apr 17
Type: Full Time
Salary (£): Negotiable
RESPONSIBILITIES Acts as CMC lead/specialist for client projects, may 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. ...
Acts as CMC lead/specialist for client projects, may have CMC responsibility for a portfolio of products.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
- 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 in collaboration with senior staff, as appropriate.
- 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.
- 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 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
- 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 an advantage
MINIMUM EDUCATION AND CERTIFICATION(S)
- Bachelor of Science Degree in life science related discipline
- Minimum 2 years regulatory CMC experience, focusing on marketed products in Europe and/or emerging markets