Exciting Job Opening in AbbVie Pharmacy! Join as a Senior Manager in Bengaluru!

AbbVie Pharmacy Regulatory Affairs Job Opening

Welcome to AbbVie Pharmacy! We are excited to announce a job opening for the position of Senior Manager, Regulatory Affairs in Bengaluru, India.

Position: Senior Manager, Regulatory Affairs

Location: Bengaluru, India

Req ID: R00092407

Category: Regulatory Affairs

Division: AbbVie

Job Responsibilities:

• Develop regulatory strategies, plans, and timelines to ensure successful new registrations and effective product maintenance, in line with local business objectives.
• Manage the regulatory submissions process, prepare high-quality submission packages, and respond to deficiency questions within applicable timelines.
• Work closely and swiftly with cross-functional and brand teams to update regulatory projects, address critical issues, and find potential solutions.
• Provide regulatory advice and support to business personnel, including tender processes.
• Review labeling, promotional, and educational materials to ensure compliance with regulations.
• Monitor and forecast the regulatory environment periodically and assess its impact on AbbVie’s business.
• Liaise with drug authorities for insights into current activities and the future direction of regulation.
• Develop and maintain regulatory operation processes and systems to support regulatory submissions and approvals efficiently.
• Develop and manage a product registration database to ensure timely and accurate information transmission.
• Develop, compile, and update local SOP on quality management systems, quality accountabilities, and working methods.
• Handle non-medical complaints according to local SOP.
• Manage the cold chain according to global SOP.
• Conduct quarterly management reviews.
• Update package inserts, corresponding overlabels, and finished product labels in a timely manner.
• Review and release finished products with proper labeling.
• Develop and manage a product quality database to ensure timely and accurate information transmission.
• Lead audit activities for QA/RA functions as required.
• Support PV audit.

Educational Requirements:

• Bachelor’s degree or above in pharmacy or related science.
• Master’s degree is preferred.
• At least 5 years of regulatory affairs experience in the pharmaceutical or biotech industry.
• Working experience with a multinational company.
• Experience with new chemical entities (NCE), biologics, and clinical trial applications.
• Familiarity with regulatory guidelines and requirements.
• Project management skills.

APPLY ONLINE HERE

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