Trainee - Regulatory Operations (Publishing)
2 days ago
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, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career **Main Job Tasks and Responsibilities**: - Responsible for the building, publishing, archiving activities and associated tasks for assigned regulatory submissions within agreed timelines. - Adhering to quality procedures and standards related to submission publishing. Adhering to the appropriate use of document management systems, publishing and validation tools, through the use of working practices and quality control steps to ensure regulatory compliance. - Support other team members with submission workload, when necessary, to provide flexible support for the submission portfolio. - Support global/local teams by completing tasks assigned by submission coordinators Adhere to Pfizer compliance standards. **Education and Experience**: - Bachelor's or Master's Degree in Pharmacy or Life Sciences. - Should possess good English language skills, both written & verbal. - Should possess good interpersonal skills with excellent collaboration capabilities. - Should be pro-active & initiative driven. - Should be solution-centric in approach. **The Application Process**: **Who will you be working for?** **About ClinChoice**: ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare **Our Company Ethos**: Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. **Key words**: Regulatory Operations Trainee, Junior Regulatory, Regulatory Affairs, Regulatory Operations, Reg Affairs, Publishing, CRO, Contract Research Organisation
-
Trainee - Regulatory Operations (Rims)
2 days ago
Bengaluru, Karnataka, India ClinChoice Full timeClinChoice 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,...
-
Regulatory Operations Associate
6 days ago
Bengaluru, Karnataka, India ICON Plc Full timeRegulatory Operations Associate - Home based - Bengaluru/ Chennai/ Trivandrum ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our...
-
Regulatory Operations Associate
4 days ago
Bengaluru, Karnataka, India Precision for Medicine Full time**Position Summary**: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA,...
-
Regulatory Operations Associate
2 weeks ago
Bengaluru, Karnataka, India Precision Medicine Group Full timeBangalore 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...
-
Ectd Publishing
4 days ago
Bengaluru, Karnataka, India Lilly Full timeAt 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...
-
Manager, Regulatory Operations
4 days ago
Bengaluru, Karnataka, India Syner-G Full time ₹ 12,00,000 - ₹ 36,00,000 per yearCOMPANY DESCRIPTION: A career here is life-enhancing.At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and...
-
Publishing Specialist
3 weeks ago
Bengaluru, India Biocon Biologics Full timeJOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards. RESPONSIBILITIES: •...
-
Publishing Specialist
3 weeks ago
Bengaluru, India Biocon Biologics Full timeJOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards. RESPONSIBILITIES: •...
-
Publishing Specialist
4 weeks ago
Bengaluru, India Biocon Biologics Full timeJOB DESCRIPTIONWe are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards.RESPONSIBILITIES:•...
-
Publishing Specialist
4 weeks ago
Bengaluru, India Biocon Biologics Full timeJOB DESCRIPTIONWe are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards.RESPONSIBILITIES:•...
