2122 Regulatory Affairs Jobs - Page 40

Working in close partnership with other RISK teams and stakeholders (systems, reporting, regulatory, Front Office), the successful candidate will contribute to SIGMAs mission, taking responsibilities in some of the following areas: Participate in methodology projects, gathering and documenting requirements, considering stakeholder interests, regulatory constraints and any potential deficiencies in the current methods exposed by quality assurance processes. Investigate, analyse and design risk methods and models, respecting the aims of accurately capturing risks whilst considering system or other environmental constraints. Design, develop and test code changes required to implement the risk m...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Required Skills: Strong coping, emotional r...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Strong coping, emotional resilience, and st...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Experience working in Client On-boarding, Accou...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Experience working in Client On-boarding, Accou...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Experience working in Client On-boarding, Accou...

This role will oversee and manage the legal functions. This position requires a seasoned legal professional with substantial experience in corporate law, compliance, and risk management. Required Candidate profile The ideal Candidate will provide strategic legal guidance, ensure compliance with legal regulations, and manage a team of legal professionals to support the company’s objectives.

Job Title: QARA ENGINEER Experience: 4.5 to 10 years Location: Bangalore Mandatory Skill: US FDA, 510K, PMA, EU MDR, QARA. Regulatory gap assessment and remediation. Job Description: The objective of this project is to identify and remediate any deficiencies in the design history files (DHF) and device master records (DMR) of the stent graft integrated with 4 branched vascular prosthesis - FROZENIX 4 Branched, ensuring adherence to relevant standards, US Food and Drug Administration ("FDA") guidelines and regulations requirements by completing all necessary tasks including document translation (Japanese to English), gap assessment, remediation and submission query support. Design verificatio...

MakeMyTrip (India) Pvt Ltd is looking for Compliance Professional to join our dynamic team and embark on a rewarding career journey Regulatory Compliance: Monitor and ensure compliance with all relevant laws, regulations, and industry standards that affect the organization Policy Development: Develop, implement, and maintain compliance policies, procedures, and programs to mitigate risks and maintain adherence to regulations Risk Assessment:Risk Analysis: Conduct risk assessments and analyze potential compliance risks, providing recommendations for risk mitigation Training and Education:Training Programs: Develop and deliver compliance training programs for employees to ensure awareness and ...

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Sea...

Regulatory Affairs Executive ( for Cosmetic Industry ) Kheda, Gujarat 3–5 Years Experience CTC up to 6 LPA Strong knowledge of global cosmetic regulations (EU/USA/ASEAN/Gulf) Expertise in labeling, claims review, and documentation

Responsible for overseeing al aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market. Developing and implementing comprehensive regulatory strategies for new drug development, including clinical trial design, data submission plans, and market access strategies. Leading the preparation and su...

As a Chartered Accountant at AKMV Consultants, you will be responsible for managing various financial activities and providing expert financial advice to clients. Your role will involve ensuring the accuracy and integrity of financial data, compliance with relevant regulations, and offering strategic financial guidance. Your responsibilities will include preparing, reviewing, and analyzing financial statements, developing and monitoring budgets and forecasts, managing tax planning and compliance activities, conducting financial analysis, assessing financial risks, ensuring compliance with regulations, and staying updated with industry trends and best practices. To qualify for this position, ...

Job Summary: We are seeking a meticulous and detail-oriented NPD (New Product Development) Documentation Specialist to join our dynamic team. The ideal candidate will be responsible for managing and maintaining all documentation related to our NPD process, ensuring accuracy, compliance, and accessibility. This role requires strong organizational skills, a keen eye for detail, and the ability to work collaboratively with cross-functional teams. Responsibilities: Develop and maintain comprehensive documentation for the entire NPD lifecycle, including project plans, design specifications, test protocols, and validation reports. Collaborate with product development, engineering, quality assuranc...

Technical Documentation: Prepare specifications, technical data sheets, literature, Certificates of Analysis (COA), Safety Data Sheets

Role & responsibilities Collaborate closely with the Submission Level Publisher to ensure timely and accurate document processing. Perform daily PDF processing tasks as per assigned workload and project requirements. Adhere strictly to submission timelines and regulatory deadlines. Conduct troubleshooting using ISI Toolbox, resolving technical issues efficiently to avoid delays. Execute quality control (QC) checks of PDF files, focusing on: Bookmarking Hyperlinking Table of Contents (TOC) accuracy Implement corrections in processed PDF files based on QC comments or review feedback. Escalate and communicate any processing issues to the Submission Specialist, particularly those involving ISI T...

Do you want to contribute to the future of healthcare As Siemens Healthineers values those who dedicate their energy and passion to this cause, our company s name is dedicated to our employees. It s their pioneering spirit, blended with our long history of engineering in the ever-evolving healthcare industry that truly makes us unique as an employer. We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone to grow both personally and professionally. Sound interesting Then come in and join India team as Regulatory Affairs Specialist. Your tasks and responsibilities: Planning and preparing product related medical device submissions for the products manu...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Product Submissions and Registration Job Category: Professional All Job Posting Locations: Pune, Maharashtra, India Job Descr...

: Job Title CSO Environmental and Social Due Diligence & Sustainable Finance Manager LocationMumbai, India Corporate TitleAS Role Description The Chief Sustainability Office is responsible for developing Deutsche Banks sustainability strategy and driving its implementation across all business divisions, infrastructure functions, and regions. Its core responsibilities include defining the strategic framework, coordinating the Banks sustainable finance activities, setting ESG standards, and overseeing regulatory and disclosure obligations. It comprises four teams: Strategy & Regional Governance , Execution, Data & Regulatory , Group Sustainability , and ESG Transparency . Strategy & Regional G...

: Job TitleBusiness Risk Analyst Corporate TitleAVP LocationMumbai, India Role Description We are seeking a Business Risk Analyst to join our global team, focusing on FinTech and VASPs. This role is critical to strengthening our control frameworks, ensuring regulatory compliance, and mitigating risks in dynamic sectors. The ideal candidate will have a strong analytic mindset and a solid foundation in risk controls, FinTech ecosystems and blockchain technology. What well offer you , 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Complementary Health screening for 35 yrs. And...

: Job TitleBusiness Risk Analyst Corporate TitleAS LocationMumbai, India Role Description We are seeking a Business Risk Analyst to join our global team, focusing on FinTech and VASPs. This role is critical to strengthening our control frameworks, ensuring regulatory compliance, and mitigating risks in dynamic sectors. The ideal candidate will have a strong analytic mindset and a solid foundation in risk controls, FinTech ecosystems and blockchain technology. What well offer you , 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Complementary Health screening for 35 yrs. And ...

Industry: Payments/ Financial Services business Functional Area: Payments and Financial Services Role: Senior Manager Reporting to :Director Legal Key Skills: Drafting, vetting, and negotiating agreements, Providing legaladvice, Product counselling, Interpreting regulations and providing guidance to internal teams, Risk identification and Management. Experience: Minimum 10+years experience, including experience inPayments/ FinancialServices/ FinTech (required). Education University Degree in law. A Masters Degree in Law is not mandatory, but will be an added advantage. Location: Bangalore PRIMARY RESPONSIBILITIES : Business Reviewing existing products, as well as new products/ features, with...

Educational Bachelor of Engineering,BTech,Master Of Engineering,MTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams tow...

Job Summary We are seeking a dynamic and experienced Formulation Scientist in Injectable division for designing and development of formulation process, ensuring quality by design (QbD) implementation, scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer. Roles & Responsibilities You will be responsible for end to end Formulation development of Inhalation including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effectiveProof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injec...

Role & responsibilities 1. Prepare, compile, and review regulatory dossiers for submission. 2. Respond to queries and deficiency letters from regulatory authorities in coordination with technical teams. 3. Co-ordinating with cross-functional teams like R&D, QA/QC, production to collection of data for submissions. 4. Maintain regulatory files and track submission and approval status using internal systems. 5. Provide regulatory input during product development, scale-up, and lifecycle management. 6. Supporting the review of product labels, cartons, and inserts to ensure compliance with regulations. 7. Ensure products comply with all regulatory requirements through each stage of development an...