AbbVies mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
Post : Senior Manager, Regulatory Affairs
Job Description :
• Develop regulatory strategies, plans and timelines, to ensure successful new registrations and effective product maintenances, in line with local business objectives.
• Manage regulatory submissions process, prepare high quality submission packages and responses to deficiency questions within applicable timelines.
• Work closely and swiftly with cross-functional and brand teams to update regulatory projects, address critical issues and potential solutions.
• Provide regulatory advices and supports to business personnel, including tender.
• Review labeling, promotional and educational materials to ensure compliance.
• Monitor and forecast regulatory environment periodically, and assess impact to AbbVie business.
• Liaise with drug authorities for insights into current activities and future direction of regulation.
• Develop and maintain regulatory operation processes and systems to support regulatory submissions and approvals in the most efficient.
• Develop and manage product registration database to ensure information transmission timely and accurately.
• Develop, compile and update local SOP on quality management systems, quality accountabilities and working methods.
• Handle non-medical complaints according to local SOP.
• Manage cold chain according to global SOP.
• Conduct management review quarterly
• .Update package inserts, corresponding overlabels and finished product labels, ensure reviews and approvals in a timely manner.
• Review and release finished products with proper labeling.
• Develop and manage product quality database to ensure information transmission timely and accurately.
• Lead audit activities for QA/RA functions as required.
• Support PV audit.
Candidate Profile
• Bachelor degree or above in pharmacy or related science.
• Master degree is preferred.
• At least 5 years regulatory affairs experience in pharmaceutical or biotech industry.
• Working experience with multinational company.
• Experience with new chemical entities (NCE), biologics and clinical trial application.
• Familiar with regulatory guidelines and requirements.
• Project management skill.
Additional Information
Qualification : B.Pharm
Location : Bengaluru, India
Category : Regulatory Affairs
End Date : 30th November, 2023
See All Bangalore Alerts B.Pharm Alerts M.Pharm Alerts M.Sc Alerts
See All Other Jobs in our Database
.png)
