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
Job ID: 30956177
- 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.
- 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.
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