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Job Details

Regulatory Affairs Officer 2

Company: Quintiles
Location: Reading
Reference: 1701413
Closing Date: 09 Apr 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

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. ...

Requirements:

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. 
  • 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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
 


Technical Skills
  • 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
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 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

Apply for this job: Regulatory Affairs Officer 2

Contact Information:

Address:  .
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England
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