AbbVie Pharmacy Regulatory Affairs Job Opening
"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.


Keywords: AbbVie Pharmacy, Regulatory Affairs job, Senior Manager, Bengaluru, India, pharmaceutical, biotech, regulatory strategies, project management, new chemical entities, biologics, clinical trial application. AbbVie Pharmacy Regulatory Affairs Job Opening. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.


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