Manager Global Regulatory Affairs And Safety Operations

Thousand Oaks, CA

Post Date: 08/04/2017 Job ID: 280905-0_1 Category: Pharmaceutical Salary: $95,000 to $105,000
Manager Global Regulatory Affairs and Safety Operations
Industry: Pharma/Biotech
Location: Thousand Oaks, Ca or REMOTE

The Manager (GRAAS) will lead a team of regulatory publisher and managers to facilitate global registration through planning, managing, tracking, and ensuring on-time production and delivery of major global filings while ensuring quality, doing more with less, and contributing to overall reduction of Data Loss Prevention (DLP) to filing time.

Key Activities for the Manager include:
1.The manager will have direct and dotted line reports
2.The incumbent will divide time between serving as a dossier management expert in Global Regulatory Operations and managing strategic direction for the group
3.Lead and guide delivery of regulatory dossiers for global filings
4.Liaise with other Global Regulatory Operations (GRO) management team members for assignment of filing-specific GRO roles
5.Elicits and analyzes needs identified by business stakeholders and convert them into functional system requirements
6.Drive and implement process and system improvements by applying Lessons Learned from previous filings to continue improving global MA filing processes
7.Communicates functional requirements by preparing the appropriate artifacts
8. Technical mastery of Electric Common Technical Document (eCTD) software

Basic Qualifications
*Doctorate degree
OR
*Master's degree and 3 years of regulatory and/or regulatory operations experience
OR
*Bachelor's degree and 5 years of regulatory and/or regulatory operations experience
OR
*Associate's degree and 10 years of regulatory and/or regulatory operations experience
OR
*High school diploma / GED and 12 years of regulatory and/or regulatory operations experience
AND
*Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:
1.Bachelor's degree, or equivalent combination of education and experience
2.5 years of Pharmaceutical or biotech industry experience in an operation-focused role within Regulatory Affairs
3.Previous experience as a lead in US/EU marketing application (publishing, regulatory affairs/CMC project management, emerging markets dossiers, regulatory affairs lead, etc.)
4.Technical mastery of US and Global Electric Common Technical Document (eCTD) requirements
5.Advanced knowledge of EU/US regional dossier structure and format
6.Working knowledge of emerging markets eCTD
7.Master knowledge of upstream processes across cross-functional filing teams
8.Master knowledge of Interdependencies and relationship between technical modules, regional differences/adaptations, and regional requirements (e.g., translations)
9.Advanced Publishing/Technical skills and knowledge (global and regional requirements)
10.Previous experience in developing innovative processes or improve existing processes to maximize efficiency cross-functionally

Ken Kupersmith
Executive Recruiter

Ken's relationship with his clients and candidates is one of personalized, knowledgeable service. His primary focus is helping companies acquire the top talent they need to grow, and working with candidates throughout their careers to put their skills to their highest and best use.Ken's practice focus is in the recruitment of Medical Affairs, MSLs, Regulatory Affairs and Medical and Scientific Writers.
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