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Lead Consultant - Regulatory Affairs

2.00 to 4.00 Years   Mumbai City   01 Feb, 2021
Headstrong
Job LocationMumbai City
EducationNot Mentioned
SalaryRs 1.5 Lakh/Yr
IndustryIT - Software
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Lead Consultant - Regulatory Affairs - CPG019712With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world s biggest brands and we have fun doing it. Now, we re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us. Are you the one we are looking for We are inviting applications for the role of LC , Regulatory Affairs! In this role, you are expected to have good knowledge of Planning and timely execution of product life cycle management projects. We are looking for some who should be open to work in any shift as per the business requirement. Responsibilities The Role demands for a highly qualified professional who can provide guidance to direct reports typically comprising of first line managers and supervisors. Senior Manager will be responsible for all the activities related to

  • Perform document level & submission level publishing, assembly and distribution activities.
  • Performing submission readiness checks.
  • Compiling SAS and other datasets and non-PDF files.
  • Publishing documents for eCTD, NeeS, paper, and other PDF format submissions.
  • Performing final technical quality review and technical validation (eCTD/NeeS)
  • In depth solid understanding of ECTD/ NEES types of submission, industry standard publishing systems.
  • Effective time management and interpersonal skills to efficiently run multiple time-sensitive assignments simultaneously
  • Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables
  • Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions
  • Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation
  • Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
Minimum Qualifications
  • Bachelor s degree in pharma / Science
  • Strong financial analytical skills and problem solving skills.
  • Effective communicate in writing and verbally to senior management.
  • Experience in balancing customer facing role and work assessments.
  • Self-starter and have analytical, problem solving skills
  • Ability to balance customer governance meetings
Preferred qualifications
  • Able to nurture robust working relationships with the team, peers and clients, scheduling flexibility required
  • Overall candidate should have problem solving, macro-level research and analytics approach and good in numbers.
  • Good people and customer handling skills.
  • Effective communication and interpersonal skill.
Job Lead Consultant Primary Location India-Mumbai Education Level Bachelors / Graduation / Equivalent Job Posting Jan 20, 2021, 3:30:58 PM Unposting Date OngoingMaster Skills List OperationsJob Category Full Time,

Keyskills :
sapdeliveryproduct life cycle managementmusic makingenvironmentproblem solvingcustomer focusproduct life cyclepostinglife cycletime managementsalescustomer relationsstatements of work sow

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