regulatory specialist

Regulatory Specialist Job at Abbott

Abbott Laboratories has released a regulatory specialist job. Candidates from B.Sc and B.Pharm may apply for this post. Find the complete details below.

Job Title: Regulatory Specialist

Education Qualifications

B. Sc. or B.Pharma with one core subject as Regulatory Affairs Advanced degree preferred

– Understand regulatory affairs in the medical device / pharmaceutical environment.

Experience Required

2 – 4 Years of Experience in the Regulatory Affairs department. Preferably in Devices industry.

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 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 license renewals to clinical trial applications and marketing authorizations
  • Coordinating and providing inputs to the development of labeling and submit labeling changes
  • Maintaining and Archival of electronic and hard copies of the regulatory submissions and tracking systems, in a timely manner
  • Identify potential regulatory approvals risks based on changes in regulations, standards country-specific issues, or other unique characteristics of the project.
  • Communicate application progress to internal stakeholders
  • Collaborate with worldwide colleagues regarding license renewals and updates
  • Assist with maintenance of regulatory files and tracking databases
  • Participates in interaction with regulatory agencies on defined matrices
  • Receives and processes requests for certificate and samples
  • Participates in cross-functional teams.
  • Contributes content for management presentations.
  • Brings forward ideas for continual process improvement.
  • Participate in group meetings and provide tactical approaches to addressing problems of moderate complexity

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