Assistant - Regulatory Publishing

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...

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...

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...

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...

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...

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Regulatory Operations Trainee on a permanent basis. You will work on projects from our varied client base,...

Applies knowledge of company and client regulatory publishing process, standard operating procedures, updates to regulatory authority guidelines, and software updates to ensure submission currency and compliance. - Communicates and coordinates effectively with project team members. Ensures timely resolution of publishing issues. - Provides quality and timely...

Applies knowledge of company and client regulatory publishing process, standard operating procedures, updates to regulatory authority guidelines, and software updates to ensure submission currency and compliance. Communicates and coordinates effectively with project team members. Ensures timely resolution of publishing issues. Provides quality and timely...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

Job Title: Regulatory Affairs BA Position: Software Engineer Experience: 3- 7 Years Category: Software Development/ Engineering Main location: India, Karnataka, Bangalore Employment Type: Full Time **Insights you can act on** While technology is at the heart of our clients’ digital transformation, we understand that people are at the heart of business...

**Job Title - Associate - International CMC Regulatory Affairs** **Career Level - C** Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get...

**Job Title: Regulatory Affairs Associate I** **Career Level - C** **Introduction to Role**: **Accountabilities**: As a Regulatory Affairs Associate, you will be responsible for document management, including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements. You will maintain...

Department – Clinical Reporting GBS Are you detail-oriented and experienced in compiling and publishing clinical and safety documents? Are you passionate about ensuring the quality and compliance of regulatory submissions? We are looking for an Associate Clinical Safety Publisher to join our team at Novo Nordisk. If you are ready for a new challenge...

Department – Clinical Reporting GBS Are you detail-oriented and experienced in compiling and publishing clinical and safety documents? Are you passionate about ensuring the quality and compliance of regulatory submissions? We are looking for an Associate Clinical Safety Publisher to join our team at Novo Nordisk. If you are ready for a new challenge...

Department – Clinical Reporting GBS Are you detail-oriented and experienced in compiling and publishing clinical and safety documents? Are you passionate about ensuring the quality and compliance of regulatory submissions? We are looking for an Associate Clinical Safety Publisher to join our team at Novo Nordisk. If you are ready for a new challenge and...

Roles and Responsibilities Actively publish research papers in the area of interest Support the accreditation and affiliation efforts. Mentor students in the engineering design of products Lead a flagship initiative of the institution. Overall Research and Development in Electronics. Contribute and Cooperate with the other Departments and Committees in...

**About AstraZeneca** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of...

Regulatory Affairs Business Analyst **Technical Skills**: - Regulatory Affairs - 3+ Years - Regulatory Publishing, CMC, eCTD - 3+ Years - Regulatory Process - 3+ Years **Technical Skill Capability Level**: - Communication - 4 (Capability Level (Scale of 1 -5)) - Working with US Teams - 4 (Capability Level (Scale of 1 -5)) Insights you can act on While...

**Job Title: Regulatory Affairs Associate I (International Regulatory Affairs)** **Career Level - C** **Introduction to Role**: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to...

Summary:A Regulatory Affairs Administrative Assistant provides crucial support to regulatory affairs experts in managing compliance, records, and administrative tasks. They have a key role in ensuring the smooth operation of the regulatory department.Responsibilities and Accountabilities:Document Management: Assist in preparing, compiling, and maintaining...