Require Regulatory Specialist at Abbott India Limited | B.Pharm, B.Sc
Post : Regulatory Specialist
• Creation of detailed written regulatory plans that can be used to develop 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 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
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.
Experience Required : 2 – 4 Years of Experience in Regulatory Affairs department.
Preferably in Devices industry
Qualification : B.Sc. or B.Pharma
Location : Mumbai
Experience : 2 – 4 Years
Job ID : 30956177
Functional Area : Regulatory Affairs
End Date : 10th August, 2020
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube