Safety Writer and Regulatory Specialist
2 weeks ago
Job 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, including Annual Reports, Periodic Safety Update Reports, and other documents as assigned.
- Lead the end-to-end process of report production and ensure quality standards and key timelines are met.
- Provide oversight to co-authors or team members as applicable and be accountable for the quality of their work.
- Act as the primary point of contact for clients for all report management activities.
- Engage in client communication to manage stakeholder expectations and present anticipated challenges.
Requirements:
- Strong writing and editing skills.
- Experience in safety and pharmacovigilance.
- Ability to work independently and as part of a team.
- Excellent communication and interpersonal skills.
What We Offer:
- A collaborative and dynamic work environment.
- Ongoing training and development opportunities.
- A competitive salary and benefits package.
-
Global Regulatory Safety Expert
1 week ago
Mumbai, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeJob Title: Principal Safety WriterAt 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,...
-
Principal Safety Writer
3 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...
-
Principal Safety Writer
4 weeks ago
Mumbai, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeJob Title: Principal Safety WriterAt CSS Fortrea Scientific Pvt Ltd, we are seeking a highly skilled and experienced Principal Safety Writer to join our team. As a key member of our safety and pharmacovigilance department, you will be responsible for writing and reviewing various safety reports for global regulatory submissions.Key Responsibilities:Write and...
-
Principal Safety Writer
4 weeks ago
Mumbai, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeJob Title: Principal Safety WriterAt CSS Fortrea Scientific Pvt Ltd, we are seeking a highly skilled Principal Safety Writer to join our team. As a key member of our clinical development 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
1 week 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...
-
Safety and Environmental Specialist
3 weeks ago
Mumbai, Maharashtra, India ASSYSTEM Full timeJob OverviewWe are seeking a highly skilled Safety and Environmental Specialist to join our team at Assystem. As a key member of our organization, you will be responsible for ensuring the safety and well-being of our employees and the environment.The ideal candidate will have a strong background in occupational health and safety, with a minimum of 10 years...
-
Product Safety Specialist
4 weeks ago
Mumbai, Maharashtra, India Huntsman Full timeProduct Safety & Stewardship SpecialistHuntsman Solutions India Pte Ltd is seeking a highly skilled Product Safety & Stewardship Specialist to join our regional team in Mumbai, India.Key Responsibilities:Assess and approve product introduction requests, ensuring compliance with national and international regulations.Classify Huntsman materials according to...
-
Product Safety Specialist
4 weeks ago
Mumbai, Maharashtra, India Huntsman Full timeJob Summary:Huntsman is seeking a Product Safety Specialist to join our team in Mumbai, India. As a Product Safety Specialist, you will be responsible for ensuring the safety and compliance of our products throughout their lifecycle.Key Responsibilities:Assess and approve product introduction requests, including new products and changes to existing...
-
Product Safety Specialist
3 weeks ago
Mumbai, Maharashtra, India Huntsman Full timeJob SummaryHuntsman is seeking a Product Safety Specialist to join our team in Mumbai, India. As a Product Safety Specialist, you will be responsible for ensuring the safety and compliance of our products throughout their lifecycle.Key ResponsibilitiesAssess and approve product introduction requests, including new products and changes to existing...
-
Senior Safety Writer and Process Lead
4 weeks ago
Mumbai, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeSenior Safety Writer and Process LeadFortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20...
-
Regulatory Compliance Specialist
2 weeks ago
Mumbai, Maharashtra, India Banking and NBFC job Full timeJob Purpose: To ensure the bank's regulatory compliance with RBI guidelines and policies, formulating and reviewing policy frameworks, and advising business units on regulatory matters.Key Responsibilities:Review and implement new products and process approval notes.Review and maintain policies and procedures.Disseminate regulatory circulars to relevant...
-
Senior Clinical Safety Specialist
3 weeks ago
Mumbai, Maharashtra, India CSS Fortrea Scientific Pvt Ltd Full timeKey Responsibilities:As a Senior Clinical Safety Specialist at CSS Fortrea Scientific Pvt Ltd, you will be responsible for writing and reviewing various safety reports for global regulatory submissions. This includes Annual Reports, Periodic Safety Update Reports, and other documents as assigned.Key Skills:Strong writing and communication skillsAbility to...
-
Environmental Health and Safety Specialist
4 weeks ago
Mumbai, Maharashtra, India Oatly AB Full timeJob Title: Environmental Health and Safety SpecialistWe are seeking a highly motivated and experienced Environmental Health and Safety Specialist to join our team at Oatly AB. As a key member of our EHS team, you will be responsible for ensuring the company's compliance with local, state, and federal regulations, as well as developing and implementing...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, Maharashtra, India ITEX Full timeAbout ITEX: As a global leader in producing high-tech medical and aesthetic devices, we are committed to innovation and excellence. Our company has offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries, making us a truly international organization.Job Overview: As a Regulatory Affairs Specialist, you will play a crucial...
-
Global Product Safety Specialist
4 weeks ago
Navi Mumbai, Maharashtra, India Nouryon Full timeAbout the RoleThe Global Product Safety Specialist plays a critical role in ensuring the safety of our products and compliance with regulatory requirements. This position is responsible for supporting the business in creating and maintaining product safety-related documents, such as Safety Data Sheets (SDS) and labels.Key ResponsibilitiesEnsure regulatory...
-
Product Safety
3 weeks ago
Mumbai, Maharashtra, India Huntsman Full timeJob SummaryHuntsman is seeking a highly skilled Product Safety & Stewardship Specialist to join our team. As a Product Safety & Stewardship Specialist, you will be responsible for ensuring the safety and compliance of our products throughout their lifecycle.Key ResponsibilitiesAssess and approve product introduction requests, including new products and...
-
Regulatory Compliance Specialist
2 weeks ago
Mumbai, Maharashtra, India Colgate-Palmolive Company Full timeAbout the RoleWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Colgate-Palmolive Company. As a key member of our Supplier Compliance team, you will play a crucial role in ensuring the regulatory compliance and sustainability of our products.Key ResponsibilitiesAs a Regulatory Compliance Specialist, you will be responsible...
-
Global Product Safety Specialist
4 weeks ago
Navi Mumbai, Maharashtra, India Nouryon Full timeAbout the RoleNouryon is seeking a highly skilled Global Product Safety Specialist to join our team. As a key member of our product safety team, you will be responsible for ensuring regulatory compliance and providing proactive classification and labeling advice to internal and external customers.Key ResponsibilitiesEnsure regulatory compliance with national...
-
Senior FSSAI Regulatory Compliance Specialist
2 weeks ago
Mumbai, Maharashtra, India Guiltfree Industries Limited Full timeAbout Guiltfree Industries Limited: At Guiltfree Industries Limited, we are a leading player in the FMCG industry, committed to delivering high-quality products that cater to the evolving needs of our customers. We are seeking a highly skilled and experienced Senior FSSAI Regulatory Compliance Specialist to join our team and help us maintain our position as...
-
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. This role requires a deep understanding of national and international regulatory programs, as well as transportation laws.Key...