GSK Recruitment Bachelors degree in biological or healthcare science for Regulatory Specialist, CTA Senior
GlaxoSmithKline Recruitment 2021.GlaxoSmithKline Notification full detailes below.GlaxoSmithKline PLC is a global healthcare company.The Company focuses on its research across six areas: Respiratory diseases, human immunodeficiency virus (HIV)/infectious diseases, Vaccines, Immuno-inflammation, Oncology and Rare diseases.
Important Vacancy details:GlaxoSmithKline Looking Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment for Regulatory Specialist, CTA Senior AT Bangalore, India-Intrested candiadte apply Now.
A. Post Name: Regulatory Specialist, CTA Senior
B. Qualifications:Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment-3-5 years of relevant experience C. Location: Bangalore, India; Worli Mumbai, India
Note:If interested candidates can share your resume to mentioned mail ID Below.
askus@gsk.com
Job Description:Are you looking for a regulatory affairs role that will enhance your documentation knowledge and allow you to help shape systems strategy? If so, this Regulatory Affairs Operations role could be an exciting opportunity to explore.
As a Regulatory Affairs Operations Staff, you will work with the Governance, Compliance, and the Systems team within Global Labelling to ensure that labelling updates in Online Product Authorisation and Lifecycle (OPAL) are monitored and managed in compliance with GSK procedures. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Broad understanding of the pharmaceutical industry, drug development environment, and R &D processes and objectives.
A good understanding of Clinical Trial Directive, DIA TMF Reference Model and CTA submission requirements for multiple countries/submission types
Responsible for: coordination, development, refinement of the CTA lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures.
Accountable to the CTA Team Manager for overall work plans, accountable to individual GRLs/TGs for study submission planning & delivery status
Accountability for agreed tasks and projects.
Ensure independent communication, with a range of internal GSK staff, in supporting achievement of the assigned goals.
Ensure quality of both own and submission team’s work, delivering to agreed timeframes, including compliance with GSK systems and record keeping.
Provide input to internal processes and written standards.
To work flexibly in order to meet constant shifting priorities and timelines
May provide support to other activities within the CTA and/or Content Delivery Team.
If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.
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