Consultant, Regulatory Affairs, Pharma, Tech Transfer, CMC, LCM, Post Approvals

5 - 7 years experience  •  Business Services

Salary depends on experience
Posted on 12/05/17
5 - 7 years experience
Business Services
Salary depends on experience
Posted on 12/05/17

QUALIFICATION SUMMARY (4-6 META QUALIFICATIONS) 1)    5+ years of Regulatory Affairs Experience: The role requires 5+ years of Regulatory systems and process experience. Strong ability to make risk based decisions.   a.    Authoring Module 3 & Defining Regulatory Strategy (Not just compiling):  This role will require more than publishing or compiling.  We are looking for someone who has worked cross functionality to author documentation and defining strategy.   b.    Document & Technical Remediation: Making sure that documents at initial site are correct.  Making sure that documents at new manufacturing site are aligned.  Ability to weight impact to regulatory strategy.  Determine impact assessment of changes related to manufacturing processes, methods, etc. c.    Tech Transfers:  Develop Dossier sections to get sites qualified from global standards.  Ability to perform impact assessments. d.    Test Method & Stability/Validation:  Analysis between registration and internal documentation.  Process change controls and work on global regulatory strategies.   2)    CMC Experience:  Experience with API, Drug Product, Manufacturing Processes & Validation, Analytical Methods, & Stability are highly preferred. 3)    eCDT & CTD Documentation Experience 4)    Team Leadership Experience:  The ideal candidate will have experience motiving a team to accomplish goals.  Matrix team experience is highly desirable. 5)    Pharmaceutical Experience:  This roles required strong and broad background with Pharmaceuticals.  Pharma experience with Regulatory, R&D, Quality, and Operations/Manufacturing are all beneficial.  Parental liquid experience is ideal. 6)    Strong Communication Experience: The ideal candidate will need to have excellent written and verbal communication skills. Ability to clearly articulate issues, impact, and mitigation strategies. 7)    Global Experience: The ideal candidate will have experience leading and communicating with global teams. 8)    Bachelor’s Degree
  ADDITIONAL QUALIFICATIONS / NICE TO HAVES 1)    Life Cycle Management or Post Approvals Experience
2)    Project Management Experience
3)    Submission Experience
4)    Sterilization Experience
5)    R&D, Manufacturing/Operations, Quality Experience

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