Global Regulatory Safety Expert
3 weeks ago
At CSS Fortrea Scientific Pvt Ltd, we seek a skilled Principal Safety Writer to join our team of experts in the field of clinical development. This role requires a strong background in writing and reviewing safety reports for global regulatory submissions.
Key Responsibilities:
- Develop and review safety reports for clients, including Annual Reports, Periodic Safety Update Reports, and other documents as assigned.
- Lead the end-to-end process of report production, ensuring quality standards and key timelines are met.
- Provide oversight to co-authors or team members, ensuring the quality of their work and contributions.
- Act as the primary point of contact for clients, managing stakeholder expectations, presenting challenges, and escalating unresolved issues.
- Author and review RMPs, ad hoc reports, and other safety-related documents.
- Participate in signal management processes, providing inputs for developing signal strategies and retrieving data from safety databases and scientific literature.
Requirements:
- Strong writing and communication skills.
- Experience with safety reporting and regulatory submissions.
- Ability to work independently and lead teams.
- Strong attention to detail and quality control.
We offer a collaborative work environment, opportunities for growth and development, and a competitive salary and benefits package.
-
Global Product Safety Expert
3 weeks ago
Navi Mumbai, Maharashtra, India Nouryon Full timeJob PurposeThe Global Product Safety Specialist supports the business on product safety related documents, ensuring regulatory compliance and business goals. This role provides proactive classification and labeling advice, as well as critical information to both internal and external customers and other parties.Key ResponsibilitiesEnsure regulatory...
-
Global Safety Data Specialist
4 weeks ago
Mumbai, Maharashtra, India Apotex Full timeAbout ApotexApotex is a leading global health company that delivers high-quality, affordable medicines to patients worldwide. With a presence in over 75 countries, our team of experts works tirelessly to ensure the safety and efficacy of our products.Job SummaryWe are seeking a skilled Global Safety Data Specialist to join our Pharmacovigilance team. The...
-
Global Product Safety Specialist
3 weeks ago
Navi Mumbai, Maharashtra, India Nouryon Full timeJob Purpose:The Global Product Safety Specialist plays a crucial role in ensuring the safety of our products by providing regulatory compliance support for safety data sheets, labels, and other hazard communication documentation.Key Responsibilities:Ensure regulatory compliance with national and international programs, including OSHA and transportation...
-
Product Stewardship Specialist
3 weeks ago
Mumbai, Maharashtra, India Kimberly-Clark Full timeJob DescriptionAs a Product Stewardship Specialist with Kimberly-Clark, you will play a critical role in ensuring the safety and regulatory compliance of our products. This includes maintaining enterprise product stewardship programs, optimizing business value, and providing direction and guidance to the K-C business community.Main ResponsibilitiesRepresent...
-
Safety Writer and Regulatory Specialist
3 weeks ago
Mumbai, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeSafety Writer and Regulatory SpecialistJob Summary:Fortrea is seeking a skilled Safety Writer and Regulatory Specialist to join our team. As a key member of our safety and pharmacovigilance team, you will be responsible for writing and reviewing various safety reports for global regulatory submissions.Key Responsibilities:Write and review safety reports,...
-
Safety Specialist and Regulatory Writer
3 weeks ago
Mumbai, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeKey ResponsibilitiesGenerate line listings and summary tabulation, CFIs, CFCs.Write and review various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and other clinical documents.Author and review RMPs, ad hoc reports, Safety Update reports, and other clinical documents.Prepare medical information...
-
Product Stewardship Specialist
4 weeks ago
Mumbai, Maharashtra, India Kimberly-Clark Full timeAbout the RoleWe are seeking a highly skilled Product Stewardship Specialist to join our team at Kimberly-Clark. In this role, you will be responsible for ensuring the safe and compliant development of our products worldwide.Key ResponsibilitiesRepresent the Product Safety, Stewardship and Medical Affairs teams with cross-functional partners to plan, manage,...
-
Safety Expert
3 weeks ago
Mumbai, Maharashtra, India Larsen & Toubro Full timeJob Title: Safety Expert - Process and OperationsJob Summary: We are seeking an experienced Safety Expert - Process and Operations to join our team at Larsen & Toubro. The successful candidate will be responsible for ensuring the safe operation of process plants, including refineries, fertilizers, and petrochemicals.Key Responsibilities:Develop and implement...
-
Regulatory Reporting Expert
13 hours ago
Mumbai, Maharashtra, India State Street Full timeJob SummaryWe are seeking a seasoned Regulatory Reporting expert to join our Global Markets India team as Vice President. This role will oversee the development and implementation of optimal regulatory reporting processes, ensuring compliance with global regulations such as MiFID II and EMIR. The ideal candidate will have a strong background in risk...
-
Regulatory Expert
3 weeks ago
Mumbai, Maharashtra, India SUN PHARMA Full timeJob SummaryAt SUN PHARMA, we are seeking a highly skilled Regulatory Expert to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and providing expert guidance on regulatory matters.Key ResponsibilitiesRegulatory Compliance: Ensure that all products and processes are in...
-
Senior Safety Specialist
6 days ago
Mumbai, Maharashtra, India Lifelancer Full timeAbout the RoleAs a Senior Safety Specialist at Organon, you will play a vital role in maintaining and performing processes to ensure high-quality and compliant reporting of aggregate safety reports in accordance with PV regulations.Job DescriptionYou will be responsible for quality review and compliance monitoring of aggregate safety reports to Health...
-
Regulatory Affairs Specialist
1 week ago
Navi Mumbai, Maharashtra, India IF MedTech Pvt Ltd Full timeIF MedTech Pvt Ltd is revolutionizing healthcare through cutting-edge medical device design, development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering, business, and research domains to bring innovative solutions that enhance healthcare and improve lives.We are seeking a skilled Regulatory Affairs Specialist...
-
Global Trade Compliance Expert
3 weeks ago
Mumbai, Maharashtra, India Ashland Full timeGlobal Trade Compliance ExpertAshland is seeking an experienced Global Trade Compliance Expert to join its Supply Chain business at Ashland India, Mumbai, Maharashtra.This highly visible role within the Company and the Supply Chain function will report to the Manager. As a Global Trade Compliance Expert, you will continually review and interpret regulatory...
-
Fire and Life Safety Manager
3 weeks ago
Mumbai, Maharashtra, India Accor Full timeAbout the RoleFairmont Hotels & Resorts is seeking a highly skilled Fire and Life Safety Manager to join its team. As a Fire and Life Safety Manager, you will be responsible for ensuring the overall contractual fire prevention and life safety program is met, including preventative and corrective maintenance, and delivery of a full inspection schedule.Key...
-
Senior Health and Safety Specialist
6 days ago
Mumbai, Maharashtra, India ADSIPL - Maharashtra - E22 Full timeAre you an experienced health and safety professional looking for a challenging role that requires strategic thinking, problem-solving, and excellent communication skills?About ADSIPLWe are a global leader in providing innovative solutions to our clients. As a Regional Safety Engineer, you will be part of our Data Center Planning and Delivery (DCPD) team,...
-
Regulatory Affairs Expert
3 weeks ago
Mumbai, Maharashtra, India General Mills Full timeJob Title: Regulatory Affairs Leader Job Summary: We are seeking a skilled Regulatory Affairs Leader to monitor regulatory changes and status in multiple markets, including India, the Middle East, and Southeast Asia. The successful candidate will conduct impact assessments for regulatory changes and partner with the business to build readiness plans. ...
-
Principal Safety Writer
4 weeks ago
Mumbai, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeJob SummaryAs a leading global contract research organization (CRO), Fortrea is seeking a highly skilled Principal Safety Writer to join our team. This role will be responsible for writing and reviewing various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports.Key...
-
Safety Manager
1 month ago
Mumbai, Maharashtra, India KEC International Ltd Full timeJob Summary:As a key member of the KEC International Ltd team, the successful candidate will be responsible for developing and implementing a comprehensive safety plan, ensuring compliance with regulatory requirements and industry standards.Key Responsibilities:Design and lead the implementation of a globally accepted HSE framework and policies for KEC...
-
Global Regulatory Data Specialist
3 weeks ago
Mumbai, Maharashtra, India IQVIA Full timeJob DescriptionAs a XeVMPD Associate, this role is responsible for managing data related to medicinal products in the XeVMPD system. Key responsibilities include ensuring data accuracy, quality, and regulatory compliance, while maintaining up-to-date knowledge of EU guidelines and regulations.Data Management• Enters and updates information about medicinal...
-
Product Safety Expert
3 weeks ago
Mumbai, Maharashtra, India Huntsman Full timeAbout the RoleHuntsman is seeking a dynamic Product Safety Expert to join our team in Mumbai, India. As a key member of our EAME Product Safety & Stewardship team, you will be responsible for ensuring the safety and compliance of our products throughout their lifecycle.Key ResponsibilitiesAssess and approve product introduction requests, classify Huntsman...