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Abbott Life Sciences Regulatory Specialist Job – Apply Online

Abbott Life Sciences Regulatory Specialist Job – Apply Online. BSc Life Sciences candidates can apply online at Abbott. BSc candidates looking for a regulatory specialist vacancy can apply at Abbott. For more details on Abbott Research Careers check details below:

Job Title: Regulatory Specialist

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Job ID: 30956177

Location: India-Mumbai

Job Description:

  • Creation of detailed written regulatory plans that can be used to develop a regulatory strategy for India
  • Preparing routine regulatory submissions which require interactions with Global
  • Regulatory department in line with India and also South Asia specific requirements and company policies and procedures
  • Preparing submissions, which may include, but are not limited to: safety reports, amendments/ Change notifications, supplements and also license renewals to clinical trial applications and also marketing authorizations
  • Coordinating and providing inputs to the development of labelling and submit labelling changes
  • Maintaining and Archival of electronic as well as hard copies of the regulatory submissions and also tracking systems, in a timely manner
  • Identify potential regulatory approvals risks based upon changes in regulations, standards nation-specific issues or other unique characteristics of the project.
  • Communicate application progress to internal stakeholders
  • Collaborate with worldwide colleagues concerning license renewals and updates
  • Aid with the maintenance of regulatory files and tracking databases
  • Participates in interaction with regulatory agencies on defined matrices
  • Receives and processes requests for certification as well as samples
  • Participates in cross-functional teams.
  • Contributes content for management presentations.
  • Brings forward ideas for continual process improvement.
  • Take part in team meetings as well as provide tactical approaches to addressing problems of moderate complexity
  • Support, Coordinate and also collaborate the development and also improvements of the local regulatory process, which have an impact on the working of the Regulatory Affairs function or other departments.
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EDUCATION QUALIFICATIONS:

  • B.Sc. or B.Pharma with one core subject as Regulatory Affairs or bachelor’s degrees in life science, clinical research studies or engineering. Advanced degree favoured.
  • Understand of regulatory affairs in the medical device/ pharmaceutical environment.

EXPERIENCE REQUIRED: 2 – 4 Years of Experience in Regulatory Affairs department. Ideally in Devices industry.

Apply Online

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