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
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.
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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