Regulatory Start Up Specialist Expert
4 days ago
About This Role
We are seeking a highly skilled Regulatory Start Up Specialist Expert to join our team at IQVIA.
Job Summary
This is a critical role that involves working closely with regulatory bodies and internal stakeholders to ensure compliance and successful start-up of clinical studies. As a Regulatory Start Up Specialist Expert, you will be responsible for creating electronic survey builds, preparing and building electronic packages, tracking queries issued by regulatory bodies, and ensuring the completion of all defined transactional activities such as Clinical Study Reports (CSRs) and Trial Master File Oversight.
Key Responsibilities
- Survey Build: Create electronic survey builds based on required documents needed for studies.
- Package Build: Prepare and build electronic packages within our system for sites, including essential documents, regulatory documents, etc.
- Query Tracking Process: Track queries issued by regulatory bodies within our electronic system.
- Informed Consent Form (ICF) Build: Create ICF templates based on country requirements received from affiliates.
- Essential Document Review: Review essential documents against checklists per country regulations.
- Completion of Transactional Activities: Complete any other defined transactional activities such as CSRs and Trial Master File Oversight.
Requirements
- Essential Skills and Qualifications: Strong understanding of regulatory requirements and processes, excellent communication skills, ability to work in a fast-paced environment, and strong analytical skills.
- Preferred Qualifications: Experience working with regulatory agencies, knowledge of clinical trials, and proficiency in relevant software systems.
Benefits
We offer a competitive salary of $90,000 - $120,000 per year, depending on experience, plus benefits such as medical, dental, and vision insurance, 401(k) matching, and paid time off.
What We Offer
At IQVIA, we provide a dynamic and supportive work environment that encourages professional growth and development. We are committed to fostering a culture of diversity, equity, and inclusion and promoting opportunities for career advancement.
-
Regulatory Reporting Expert
3 weeks ago
Mumbai, Maharashtra, India DBS Bank Full timeJob DescriptionAs a highly skilled Regulatory Reporting Expert, you will play a critical role in ensuring the accuracy and timeliness of regulatory submissions. With a strong background in risk management and a keen eye for detail, you will be responsible for coordinating with Business Units across the Bank to gather requirements for automation projects....
-
Regulatory Compliance Specialist
3 weeks ago
Mumbai, Maharashtra, India Kotak Mutual Fund Full timeJob SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Kotak Mutual Fund.Responsibilities:Provide exceptional customer service and maintain a high level of professionalism in all interactions with stakeholders.Review marketing materials and product promotion materials to ensure compliance with regulatory...
-
Regulatory Affairs Specialist
4 weeks 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...
-
Regulatory Compliance Specialist
2 weeks ago
Mumbai, Maharashtra, India Indian Institute of Technology Bombay Development and Relations Foundation (IITB DRF) Full timeJob SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at the Indian Institute of Technology Bombay Development and Relations Foundation (IITB DRF) in Mumbai. As a key member of our quality assurance team, you will play a critical role in ensuring compliance with Good Manufacturing Practice (GMP) regulations and...
-
Tax and Regulatory Expert
4 weeks ago
Mumbai, Maharashtra, India Ananta Resource Management Full timeAnanta Resource Management is seeking a highly skilled Tax and Regulatory Expert to join our team. The ideal candidate will have a strong passion for tax and regulatory aspects and a minimum of 4 years of experience in tax and regulatory practice.Responsibilities:Direct and Indirect Tax and transfer pricingIncorporation of companies and obtaining various...
-
Mumbai, Maharashtra, India OMC Medical Limited Full timeCompany OverviewOMC Medical Limited is a healthcare company based in the UK, specializing in UK MHRA Registration, European Authorized Representation, global product registrations, and other regulatory services.Salary £40,000 - £60,000 per annum, depending on experience.Job DescriptionThis is a full-time, remote-based role for a Regulatory Affairs Human...
-
Regulatory Compliance Specialist
3 weeks ago
Mumbai, Maharashtra, India RBC Capital Markets, LLC Full timeOverview of the RoleWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at RBC Capital Markets, LLC. This individual will be responsible for providing advisory coverage and conducting ongoing monitoring of various banking activities to ensure compliance with key regulations issued by City National Bank's primary U.S.-based...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer in Mumbai, India. As a key member of our Regulatory Operations department, you will be responsible for ensuring compliance with regulatory requirements across various product categories.The ideal candidate will have a BS degree in Pharmacy or Life Sciences and 1+...
-
Product Safety Specialist
3 days ago
Navi Mumbai, Maharashtra, India Nouryon Full timeWe are seeking a highly skilled Product Safety Specialist to join our team at Nouryon. As a key member of our organization, you will play a critical role in ensuring regulatory compliance and supporting business goals through proactive classification and labeling advice.Key Responsibilities:Regulatory Compliance: Ensure safety data sheets, labels, and other...
-
Regulatory Compliance Specialist
1 day ago
Mumbai, Maharashtra, India Chemill Pharma Ltd. Full timeChemill Pharma Ltd. offers a competitive salary of $120,000 for this challenging role. As a Regulatory Compliance Specialist, you will be responsible for ensuring all regulatory submissions are complete, accurate, and compliant with country-specific guidelines.About the JobThe successful candidate will have a strong understanding of country-specific...
-
Avendus Regulatory Compliance Expert
4 days ago
Mumbai, Maharashtra, India Avendus Full timeJob OverviewWe are seeking a skilled Regulatory Compliance Expert to join our team at Avendus. As a key member of our compliance department, you will be responsible for ensuring adherence to extant guidelines issued by the Reserve Bank of India (RBI) and providing critical support in handling regulatory inspections and correspondence.About the RoleThis is an...
-
Regulatory Affairs Specialist
1 week ago
Mumbai, Maharashtra, India Lifelancer Full timeJob TitleRegulatory Affairs SpecialistAbout the JobLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We are seeking an experienced Regulatory Affairs Specialist to join our team.Salary and BenefitsThe estimated salary for this role is $120,000 per year, taking into account the location of Mumbai, Maharashtra, India, and the required...
-
Regulatory Compliance Specialist
1 week ago
Mumbai, Maharashtra, India Ipca Laboratories Limited Full timeJob DescriptionWe are looking for a highly skilled Regulatory Compliance Specialist to join our team at Ipca Laboratories Limited.This role is responsible for ensuring compliance with regulatory requirements for the USA market. The ideal candidate will have a strong background in regulated markets, specifically in the USA, and experience with ANDA...
-
Senior Regulatory Compliance Specialist
2 weeks ago
Mumbai, Maharashtra, India jai kisan Full timeWe are seeking a highly experienced Senior Regulatory Compliance Specialist to join our team at Jai Kisan. The ideal candidate will have a minimum of 3 years of experience in handling NBFC compliance and possess excellent knowledge of RBI regulations, company law, FEMA, and other regulatory requirements.**Job Summary:**
-
Senior Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Vision Achievement Full timeVision AchievementWe are seeking a highly experienced and skilled Senior Regulatory Affairs Specialist to join our team at Vision Achievement. This is an exciting opportunity for professionals who have a passion for patient safety and population health improvement.About the Role:As a Senior Regulatory Affairs Specialist, you will be responsible for planning...
-
Electricity Markets Regulatory Expert
1 week ago
Mumbai, Maharashtra, India Idam Infrastructure Advisory Pvt. Ltd. Full timeIdam Infrastructure Advisory Pvt. Ltd. is a leading advisory firm specializing in energy sector consulting.Estimated Annual Salary: ₹12,00,000 - ₹18,00,000Job OverviewWe are seeking an experienced Electricity Markets Regulatory Expert to join our team in Mumbai/Delhi.The ideal candidate will have a strong background in policy and regulatory consulting,...
-
Enterprise Middleware Support Specialist
3 weeks ago
Mumbai, Maharashtra, India Awign Expert Full timeAbout Awign ExpertAwign Expert is a leading provider of cutting-edge middleware solutions. We are committed to delivering exceptional support services to our clients.Salary PackageThe salary for this role is estimated at ₹ 1,500,000 - ₹ 2,500,000 per annum, based on the candidate's qualifications and experience.Job DescriptionWe are seeking a highly...
-
Financial Markets Regulatory Specialist
7 days ago
Mumbai, Maharashtra, India Adept Consulting Partners Full timeAbout Adept Consulting Partners">We are seeking a skilled Financial Markets Regulatory Specialist to join our team in Mumbai / Delhi.SalaryThe estimated annual salary for this position is ₹12,00,000 - ₹20,00,000 (depending on experience).Job DescriptionAs a Financial Markets Regulatory Specialist, you will be responsible for advising listed companies and...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Lifelancer Full time**Overview of Regulatory Affairs Role in Life Sciences**Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma, and IT, is seeking an experienced Regulatory Affairs Specialist to join our team. This role plays a critical part in ensuring compliance with regulatory requirements for product registration, maintenance, and advocacy.The ideal...
-
Regulatory Compliance Specialist
3 weeks ago
Mumbai, Maharashtra, India Upstox Full timeJob SummaryWe are seeking a skilled Regulatory Compliance Specialist to join our team at Upstox. As a key member of our compliance operations, you will be responsible for ensuring that all regulatory requirements are met and maintained across our organization.About the RoleThis is a challenging opportunity to work in a fast-paced environment and make a...