3 Days Left: Senior Regulatory Affairs Specialist
3 weeks ago
Job Description Company Description Dyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment. Role Description This is a full-time on-site role for a Senior Regulatory Affairs Specialist, located in Hyderabad. The Senior Regulatory Affairs Specialist will be responsible for managing regulatory documentation, ensuring regulatory compliance, overseeing regulatory submissions, and staying updated with regulatory requirements. This role involves coordinating with various departments to ensure all regulatory affairs are handled efficiently. Qualifications - Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field. - 5+ years of experience in regulatory affairs with a focus on eCTD and CTD submissions for both regulated and non-regulated countries. - Hands-on experience with eCTD submission software. - Experience with submission systems and document management processes. - Experience with Regulatory Documentation, Regulatory Compliance, and Regulatory Requirements. - Proficiency in Regulatory Affairs and Regulatory Submissions. - Strong understanding of global regulatory standards and procedures. - Excellent attention to detail and organizational skills. - Strong communication skills, both verbal and written. - Ability to work collaboratively in an on-site setting. - Problem-solving skills and the ability to troubleshoot technical issues related to client's eCTD submissions. Key Responsibilities - Develop and manage our own eCTD software tool for the creation, validation, and submission of regulatory dossiers for all the regions - Stay up to date with the latest regulatory guidelines, standards, and requirements related to eCTD/CTD submissions. - Continuously review and analyze regulatory trends and changes to ensure ongoing compliance and implementation of industry's best practices. - Conduct troubleshooting and resolve any issues related to eCTD/CTD submission formats and software functionality for our clients. - Provide training and support to Development Team on the use of RA tools and best practices. - Conduct quality checks on our software and ensure they adhere to submission guidelines. - Assist in making our software more robust, user friendly and easy to use. - Keep up to date with new regulatory developments and technological advancements related to eCTD/CTD submissions and ensure team members are informed. - Collaborate with clients to ensure all their submission-related requirements are met for successful filings.
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Senior Regulatory Affairs Specialist
3 days ago
Hyderabad, Telangana, India Dyaz Innovate Full time ₹ 8,00,000 - ₹ 24,00,000 per yearCompany DescriptionDyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment.Role DescriptionThis is a full-timeon-siterole for a Senior Regulatory...
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[3 Days Left] Regulatory Affairs Specialist
6 days ago
India Dr. Reddy's Laboratories Full timeJob Summary We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Specialist
6 days ago
India Concept Medical Full timeAbout Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...
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▷ [Urgent] Regulatory Affairs Specialist
4 days ago
Gurugram, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Specialist Job Description Job title: Regulatory Affairs Specialist Your role: Regulatory Affairs Specialist - ISC will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs Team and help business with product registration in the India Sub Continent, actively providing value-added...
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Regulatory Affairs Specialist
4 weeks ago
Mumbai, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full timeJob Description Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 4 years of experience in regulatory affairs Salary : good hike on current salary Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities: -...
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Regulatory Affairs IT Architect
4 weeks ago
Hyderabad, India beBeeTechnical Full timeSenior Technical Solution Specialist Create innovative IT solutions and services to meet quality and performance requirements and technical constraints. About the Role This position requires a consultant and advisor to improve complex global business processes, products, and services in Regulatory Affairs. Lead technical activities for transformative...
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Regulatory Affairs Operations Specialist
2 weeks ago
Pune, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Operations Specialist Job Description Job Responsibilities: - International Registrations - Upload, Verify, and Validate the data with new Regulatory Information to the RIM database - Maintain Registration &Licensing Information - Create Submission Packages for International Registrations - Initiate Renewals with...
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Regulatory Affairs Specialist
4 days ago
Hyderabad, India Dr. Reddy's Laboratories Full timeJob Summary We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Specialist
2 weeks ago
Hyderabad, Telangana, India Medtronic Full time ₹ 5,00,000 - ₹ 12,00,000 per yearAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeRegulatory Affairs Specialist In this exciting role as a Regulatory Affair Specialist, you will...
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Meerut, India Hayai Pharma Private Limited Full timeJob Description Company Description Hayai Pharma is the Exporter of finished formulation of medicines accross various geographies. Role Description This is a full-time on-site role for a Senior Manager Regulatory Affairs, based in Meerut, Delhi NCR. The Senior Manager Regulatory Affairs will be responsible for preparations of filings for product or site...
