Job Summary :
Oversee all assigned projects/products/processes. Reporting to Director RA & Compliance / Manager RA & Compliance - India and South Asia. Ensuring Abbott’s Strategic implementation in line with India & South Asia specific regulations, including compilation and submission of any required documents to regulatory agencies. Act as liaison with Regulators for assigned projects. Supervises assigned designated personnel.
Oversee all assigned projects/products/processes. Reporting to Director RA & Compliance / Manager RA & Compliance - India and South Asia. Ensuring Abbott’s Strategic implementation in line with India & South Asia specific regulations, including compilation and submission of any required documents to regulatory agencies. Act as liaison with Regulators for assigned projects. Supervises assigned designated personnel.
Job Description
• Creation of detailed written regulatory plans that can be used to develop regulatory strategy for India and South Asia
• 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 labelling and submit labelling 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 Support, Coordinate and collaborate the development and improvements of local regulatory process, which have an impact on the working of the Regulatory Affairs function or other departments.
• Creation of detailed written regulatory plans that can be used to develop regulatory strategy for India and South Asia
• 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 labelling and submit labelling 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 Support, Coordinate and collaborate the development and improvements of local regulatory process, which have an impact on the working of the Regulatory Affairs function or other departments.
Candidate Profile
• B.Sc. or B.Pharma with one core subject as Regulatory Affairs or bachelor's degrees in a life science, clinical research studies or engineering.
• Advanced degree preferred
• Understand of regulatory affairs in medical device / pharmaceutical environment.
• B.Sc. or B.Pharma with one core subject as Regulatory Affairs or bachelor's degrees in a life science, clinical research studies or engineering.
• Advanced degree preferred
• Understand of regulatory affairs in medical device / pharmaceutical environment.
Additional Information
Experience : 2-4 years
Qualification : B.Sc, B.Pharm
Location : Delhi
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 25th May, 2019
Experience : 2-4 years
Qualification : B.Sc, B.Pharm
Location : Delhi
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 25th May, 2019
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