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PLS Manager, GRSS

3.00 to 5.00 Years   Chennai   20 Feb, 2021
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Why Patients Need YouWere looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.What You Will AchieveManage & lead delivery of Product License Support Portfolio from Chennai GRRS team Involve in people management, provide feedbacks & support individual growth plan Identify opportunities and implement solutions through interaction with other team members, and keycontributors across sites, ensuring ability to maintain compliance with assigned processes and continuouslyimprove on those processes Knowledge share and educate personnel as appropriate on agency requirements and guidelines. Lead or participation on global/local teams to complete assignments and tasks within a specific taskforce/project. Involve process development and change management in the context of PLS submissions Liaison with internal stakeholders for issues regarding standards and processes, and drives resolution Utilization support of electronic technologies for submissions and tracking of documentation Matrix management of cross-functional teams as appropriate Development and maintenance of documented procedures and guidelines as necessaryHow You Will Achieve It

  • Contribute to the completion of project milestones and organize own work to meet project task deadlines.
  • Execute, through use of standards and tools, designated operational tasks or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.
  • Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level
  • Support the regulatory activities associated with allocated new food supplements in development.
  • Compile, verify accuracy, and sort regulatory license information for products identified for withdrawal.
  • Contribute to effective forecasting and management of project specific resources utilizing flexible resourcing, and global load sharing as normal business practice.
  • Communicate with internal team members about execution and strategy as needed
  • Actively pursue training in technical and personal skills relevant to the Certificate Signing Request Coordinator role.
  • Act as a subject matter expert on global regulatory requirements in the cross functional team.
QualificationsMust-Have
  • Bachelors Degree
  • Demonstrated experience
  • Relevant experience in electronic submissions build within the Pharmaceutical Industry
  • Demonstrated coordination of activities in a highly regulated environment
  • Demonstrated experience working in a challenging customer service environment
  • Knowledge of the drug development process
  • In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation
  • Good knowledge of English, spoken and written
Nice-to-Have
  • Experience in project management
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs #LI-PFE,

Keyskills :
equal employment opportunitypersonal skillscustomer servicefood supplementsdrug developmentchange managementpeople managementcorporate liaisonmatrix managementproject management

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