Assistant - Regulatory Publishing

7 days ago


Bengaluru Karnataka, India DXC Technology Full time

Successfully meet/ complete training milestones relevant to the position held.
- Familiarity with FDA and ICH guidelines, Life Sciences & Pharmaceutical industry
- Good knowledge on FDA, GCPs, ICH guidelines, Life Sciences and Pharmaceutical Industry.
- Familiarity of health authority procedures / guidance regarding electronic submissions
- Perform submission publishing, assembly, and distribution activities within the specified training period.
- Notifying relevant stakeholders that the file is ready for approval.
- Multi-skilled on all allocated submissions within the team
- Adapting and willing to multi-skill and assisting in other submission/task within the team
- A high level of independent judgment/action in problem solving
- Keeping Team Leader informed of non-routine issues, making recommendations to resolve these issues.
- Self-Developments and Take Responsibilities for the same
- Active involvement in projects and quality/change initiatives
- By continually upgrading domain knowledge
- Following company rules and standard operating procedures
- Adhering to all Security Policies and Procedures
- Promoting a positive and professional image of the team always
- Bachelor’s degree in life sciences specialty (pharmaceutical /biotech) years of Regulatory Publishing experience
- Minimal supervision required for common publishing tasks



  • Bengaluru, Karnataka, India Veranex, Inc. Full time

    Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...


  • Bengaluru, India Indegene Full time

    Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most...


  • Bangalore, Karnataka, India AstraZeneca Full time

    Job Title Regulatory Dossier Manager Introduction to role Are you ready to make a difference in the world of regulatory affairs As a Regulatory Dossier Manager you ll play a pivotal role within the Regulatory Technology Operational Excellence framework supporting our global regulatory partners Your mission is to assist in planning and coordinating major...


  • Bengaluru, Karnataka, India ClinChoice Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Primary Responsibilities:• Compile electronic- or paper-based-submissions necessary to meet regulatory requirements using available electronic publishing tools such as Docubridge/Insight Publisher/EXTEDO for EMA US markets and ROW.• Dispatch electronic submissions through health authority portals.• Provide support for data entry, maintenance and...


  • Bengaluru, Karnataka, India Precision Medicine Group Full time

    Bangalore Karnataka India **Job Type**: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5566 **Position Summary**: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This...


  • Bengaluru, Karnataka, India State Street Full time

    Job Description' Who we are looking for We are looking for a strong and passionate Digital Web Publisher to assist with delivering the digital transformation program, and support the ongoing digital needs of the State Street Global Advisors’ business Why this role is important to us The team you will be joining is a part of State Street Global...


  • Bengaluru, Karnataka, India symplr Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Overview:The Regulatory Technical Writer is responsible for producing regulatory documentation and customer communications for our Midas product suite, with a focus on healthcare. This role requires exceptional attention to detail and proficiency in content tools to meet both internal quality standards and external regulatory requirements.The Technical...


  • Bangalore, Karnataka, India symplr Full time

    Overview The Regulatory Technical Writer is responsible for producing regulatory documentation and customer communications for our Midas product suite with a focus on healthcare This role requires exceptional attention to detail and proficiency in content tools to meet both internal quality standards and external regulatory requirements The Technical Writer...


  • Bengaluru, Karnataka, India IQVIA Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Regulatory Affairs Officer Job Overview Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions • Acts as a Regulatory Team Member on...


  • Bengaluru, Karnataka, India IQVIA Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Job OverviewUnder general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.Essential Functions• Acts as a Regulatory Team Member on small, straightforward regulatory projects...