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
B. Sc. or B.Pharma with one core subject as Regulatory Affairs Advanced degree preferred
– Understand regulatory affairs in the medical device / pharmaceutical environment.
2 – 4 Years of Experience in the Regulatory Affairs department. Preferably in Devices industry.
- 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