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
- 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.
- 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.
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