Regulatory Affairs Work from Home Jobs at Icon Plc – Drug / Device Regulatory Publishing Specialist

Regulatory Publishing Specialist Work from Home Jobs at Icon Plc

Are you looking for a career in regulatory affairs with the flexibility to work from home? Icon Plc, a world-leading healthcare intelligence and clinical research organization, is hiring a DRUG / DEVICE REGULATORY Publishing Specialist. This role offers an excellent opportunity to work remotely from various locations, including Bangalore, Chennai, and Trivandrum. Read on to learn more about the qualifications, responsibilities, and benefits of this exciting role.

About Icon Plc

Icon Plc is renowned for advancing clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, government, and public health organizations. With a focus on patient-centered outcomes, Icon Plc accelerates the development of drugs and devices that save lives and improve quality of life.

Job Responsibilities

As a DRUG / DEVICE REGULATORY Publishing Specialist, your primary responsibilities will include:

1. Publishing Support: Provide publishing support in the development of global eCTD regulatory submissions.
2. Primary Contact: Serve as the primary point of contact and subject matter expert (SME) on product Global Regulatory Team (GRT) meetings.
3. Compilation and Publishing: Compile and publish eCTD, NeeS, and other electronic regulatory submission types.
4. Strategy and Planning: Provide strategy on planning and publishing timeframe required for specific submissions.
5. Independent Publishing: Drive the publishing process for routine submissions independently.
6. Collaboration: Collaborate with other submission publishers to ensure standard practices and quality submission outcomes.
7. Education and Training: Educate document authors on technical submission formats, lifecycle management, and regional submission requirements.
8. Submission Coordination: Act as submission coordinator for high-complexity functional or cross-functional submissions.
9. Efficiency Promotion: Promote submission publishing efficiencies by standardizing processes and reusing documents.
10. Quality Control: Perform quality control review of submission component documents.
11. Issue Escalation: Proactively identify and escalate publishing issues.
12. Meeting Participation: Actively participate in local and global publishing meetings.

Required Qualifications

To qualify for the Regulatory Affairs Work from Home jobs at Icon Plc, you must meet the following qualifications:

• Educational Background: Bachelor’s degree in a relevant field of study.
• Experience:  3 year of relevant experience or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above.
• All employees must read, write and speak fluent English and host country language.
• Intermediate knowledge of regulations governing pharmaceutical/eCTD submissions
• Proficiency in use of electronic submission publishing tools and/or document management systems
• Excellent communication, interpersonal and time management skills
• Ability to work autonomously under limited direction
• To qualify, applicants must be legally authorized to work India, and should not require, now or in the future, sponsorship for employment visa status

Job Location

This is a home-based position in India, with opportunities to work remotely from various cities, including Bangalore, Chennai, and Trivandrum.

Apply Now

If you are passionate about regulatory affairs and seek a flexible work-from-home job, apply now for the DRUG / DEVICE REGULATORY Publishing Specialist position at Icon Plc. For more details and to submit your application, visit Icon Plc Careers.