Regulatory Affairs Associate Documentation
About the Role
Company Overview
Sandoz is among the top leaders in the world for generic drugs and biosimilars. Its mission is centered around making affordable healthcare more accessible. Sandoz works in many countries and helps patients across the globe. The organization uses its scientific skills along with its commitment to quality and compliance. Collaboration, innovation, and constant improvement are the core values at Sandoz.
Job Summary
The job Regulatory Affairs Associate – Documentation is related to regulatory documentation and compliance procedures. It includes maintenance of records and the documentation process. The candidate will have to organize regulatory documentation according to the company guidelines and international standards. In addition to that, the candidate will help in documentation control, record keeping, and regulation submission.
The candidate will have to work closely with the concerned parties and different teams.
Key Responsibilities
The candidate will be responsible for ensuring the upkeep of controlled documentation systems. This involves the upkeep of document retention and documentation archiving. The objective of this position is to ensure that all processes are within legal regulations. The candidate will be in charge of managing the change control process for documentation and updating of records.
The candidate will organize and keep track of technical and non-technical documents. The candidate will ensure that all documentation is organized using set standards. The candidate will help coordinate the activities of regulatory documentation, including dossier compilation.
The position may involve analyzing and reviewing data and extraction of information. The candidate will be responsible for summarizing and compiling documentation. The candidate will manage product documentation and database systems.
The candidate is expected to carry out normal activities in a supervised environment, following existing procedures. The individual will make sure that assigned tasks are completed in time. This position will require the reporting of technical complaints, adverse events, or special situations in accordance with specified deadlines.
The candidate will engage in interactions with colleagues and superiors for updates.
Qualifications and Skill Requirement
Education- Bachelor’s degree in:
Life Sciences
Pharmacy, or
Related field
Experience of two to three years in the area of regulatory affairs/documenting is usually needed for the position. Basic understanding of regulatory practices and documenting procedures is needed from the applicant.
The candidate needs to have strong organizational skills along with good attention to detail. Good communication and coordination skills are required for the position.
Basic skills related to data handling and documentation management are desired for the position.
Salary and Benefits
Sandoz offers competitive compensation based on experience and industry standards. The salary for this job role is INR 6-8 LPA. Employees benefit from working in a global pharmaceutical organisation.
The company provides training programs and opportunities for career development. Employees may receive health benefits, performance incentives, and other company benefits.
Role Importance and Career Growth
This job role is vital in ensuring compliance and proper documentation. Proper documentation is important for product approval and lifecycle management. It provides an opportunity to be exposed to international regulatory processes and global standards. It is a good chance for career advancement to Regulatory Affairs Specialist/Senior Associate.
How To Apply
If this is the position you seek to apply for, you should apply through the following procedure:
Create your account in Jobslly.
Search for the position Regulatory Affairs Associate – Documentation / Sandoz.
Upload your updated resume.
Upload all the related certificates.
Complete the application form.
Ensure your resume highlights relevant education, attention to detail, and any experience in Regulatory Affairs.
Market Insights & Trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.