hireejobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Lead Consultant - Regulatory Affairs

3.00 to 6.00 Years   Mumbai City   18 May, 2021
Genpact India Pvt Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Lead Consultant, Regulatory affairs In this role, you will be responsible to work on deadlines, in a fairly high pressure business environment while being a good team member. You should have the ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.ResponsibilitiesThe Role demands for a highly qualified professional who should have CMC experience under regulatory affairs domain. BA will be responsible for all the activities related to

  • Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
  • Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
  • Collaborate closely with MMD and partners to support compliant execution of organizational change and conduct all activities with an unwavering focus on regulatory conformance.
  • Assess and communicate potential regulatory risks and propose mitigation strategies.
  • Deliver all regulatory results for assigned products across the product lifecycle
  • Identify and communicate potential regulatory issues to GRACS CMC, as needed
  • Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
  • Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key partners.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
  • Capability to handle multiple priorities and balance work to achieve business goals.
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, prioritization skills
  • Ability to balance customer governance meetings
Preferred qualifications
  • Able to further robust working relationships with the team, peers and clients, scheduling flexibility required
  • Overall candidate should have decision-making, macro-level research and analytics approach and good in numbers.
  • Good people and customer handling skills.
  • Effective communication and interpersonal skill.
,

Keyskills :
sapenvironmentdeliverycustomer relationssaleshandle multiple prioritiesenvironmental impact assessmentcontinuous improvement facilitation

APPLY NOW

Lead Consultant - Regulatory Affairs Related Jobs

© 2019 Hireejobs All Rights Reserved