2122 Regulatory Affairs Jobs - Page 29

Description Regulatory Associate (EU Market) Homebased Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem ...

Hiring for DRA Manager Location- Panchkula Experience- 15+ years Salary Package- 13-17 LPA Must have experience in regulatory Countries dossier preparation and working Should have worked in Injectable Unit Interested One share resume 9815675900

Experience in review and compile the registration and renewal dossiers as per Emerging markets. Review of master documents (PDP, PDR, AMV, MFR, MPR, Specifications, PVR, and Stability Protocols) and DMF. Experience of Handling post-approval changes for Emerging markets

To handle the proposed changes as per the change control procedure. To assess the risk / impact associated with proposed change and to verify the implementation of action plan as per approved change control form. To determine the investigation plan and carry out investigations using appropriate root cause analysis tools, assessing the risk associated with them, to perform the additional studies and to derive the appropriate CAPA. To handle the recommended CAPA and to verify the implementation of recommended actions as per CAPA system and to evaluate effectiveness checks of implemented CAPA. To perform the trend analysis of deviation, change control, complaints etc.. to identify any repetitiv...

About The Role : Job TitleCorporate Trust - Debt & Agency, Analyst LocationMumbai, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services, and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. Trust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deut...

About The Role : Job TitleRegulatory Reporting Associate LocationBangalore, India Role Description Regulatory Reporting is responsible for establishing and maintaining control frameworks designed to manage regulatory - monitoring, surveillance, compliance, transaction monitoring and screening. As a Regulatory Reporting team member, you will be responsible for managing daily reporting tasks and remediation activities. What well offer you , 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Participate in change and BAU activities. Perform daily reviews ...

About The Role : Job TitleRegulatory Control Analyst Corporate TitleAssociate LocationBangalore, India Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collecti...

Qualification: M.Sc. / M.Pharm / Ph.D. in Life Sciences, Biomedical Sciences, Biotechnology, or a related field Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist with strong experience in medical and clinical writing, focused on regulatory compliance under EU IVDR. The ideal candidate will have hands-on expertise in authoring key performance evaluation documents and supporting the preparation and maintenance of Technical Documentation (TD) for CE marking of IVD products. In addition to EU IVDR compliance, the candidate will support global product registration efforts , including preparation of regulatory documentation for submission in multiple markets. The role requ...

Job Purpose and Impact The Business Analyst - HR Core will lead efforts through influence that will enable change in an organizational context through the creation of the definition of the business needs and the creation of solution recommendations that deliver value to stakeholders. In this role, you will use advanced knowledge of the tasks and techniques that are used to perform complex business analysis such as solution evaluation, strategy analysis, elicitation and collaboration, requirement life cycle management, requirements analysis and design definitions and business analysis planning and monitoring to advance the profitability or efficiency of the business. You will partner effectiv...

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy 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 ...

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy 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 ...

About the Role: Leap Scholar is a one-stop platform for any aspirant wishing to study abroad. It is a transaction platform for students to apply to the university of choice. The charter for this role will include: Conduct online telephonic and/or virtual counselling sessions with students interested in studying abroad Guide students on what courses to opt for based on their profile and interest Assist students on deciding on the universities/colleges and programs to opt for Assist in preparing and filing of their applications Guiding students on the visa process and visa applications Participate in educational activities such as exhibitions and events as and when required Ideal Persona would...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Contract Management Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Contract Lifecycle Management (CLM) Subject Matter Expert (SME) is someone with deep knowledge and experience in using CobbleStone's Contract Insight software to manage the entire contract lifecycle. This includes tasks like contract requests, authoring, negotiation, approval, execution, management, and renewal. They understand the system's features, configurations...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Contract Management Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Contract Lifecycle Management (CLM) Subject Matter Expert (SME) is someone with deep knowledge and experience in using CobbleStone's Contract Insight software to manage the entire contract lifecycle. This includes tasks like contract requests, authoring, negotiation, approval, execution, management, and renewal. They understand the system's features, configurations...

Job title: Regulatory Affairs Advisor Location: Global Flexible World-changing careers, enabled by Johnson Matthey. With more than 200 years history, join us and help to accelerate the transition to net-zero! As a Regulatory Affairs Advisor, working as part of the Product Stewardship and Sustainability team, you ll contribute to JM s mission as a world leader in sustainable technology, transforming energy and reducing carbon emissions for a cleaner, brighter future. The role: As a Regulatory Affairs Advisor, you will help drive our goals by: Supporting the delivery of robust regulatory affairs services to the Catalyst Technologies business, as part of a newly formed Catalyst Technologies Pro...

Job Summary: Responsible for overseeing quality control activities for soap, fatty acid, and cosmetic products, ensuring compliance with legal and regulatory requirements, and maintaining product quality standards. The role involves team supervision, customer complaint handling, and liaison with government authorities. Key Responsibilities: Perform and supervise QC testing of raw materials, in-process and finished goods. Ensure compliance with GMP, cGLP, and internal quality standards. Liaison with regulatory bodies (FDA, BIS, Pollution Board, etc.) and handle inspections/audits. Address and investigate customer complaints; implement corrective actions. Train and guide QC staff and ensure ad...

Regulatory Affairs associate with knowledge in Indian Market. Customer & Regulatory communication and responses, Vendor qualification, Tracking of changes, Preparation of DMF's, Regulatory Affairs with knowledge in Indian Market. Required Candidate profile Candidates from Pharma background only with experience in Regulatory Affairs on Indian Market.

The Compliance Engineer will play a crucial role in ensuring product material regulations compliance. Collaborating with cross-functional teams and regulatory authorities, you will drive compliance initiatives to mitigate risks related to product material compliance against various regulations. You will deliver product information to iPoint Systems, submit detailed Product Bill of Materials (BOMs) along with part and supplier data, and perform high/low-risk parts analysis based on Material Data File (MDF) category risk assessments. Collaborating with Engineering and Portfolio/Product Management teams, you will ensure BOM data quality and accuracy. Additionally, you will work with Supply Chai...

You will be responsible for preparing, reviewing, and implementing Standard Operating Procedures of Quality Assurance, ensuring that day-to-day QA Controls are in place, and empowering QA for the entire plant. Your role will involve establishing, implementing, and maintaining the necessary processes for the Quality management system. You will adopt a document control procedure to approve, review, and update all changes to documents within the scope of the Quality Management System. Issuance of Quality Management System related formats and maintaining the log accordingly will be under your purview. You will be required to follow up on deviations, change controls, incidents, material and produ...

We are looking for an experienced Regulatory Affairs professional with in-depth knowledge of injectable dossiers and a strong understanding of US FDA regulatory pathways. As the ideal candidate, you will have a crucial role in ensuring the successful submission and management of injectable products for regulated markets, with a focus on the United States. Your responsibilities will include compiling Abbreviated New Drug Applications (ANDAs) and Sterility Assurance Packages for ANDA filings. You will be expected to provide timely responses to ANDA deficiencies such as IRs, CRLs, and DRLs. Managing labeling compilation, including SPL files and annotated comparisons vs. RLD labels will also be ...

As a Business Development Manager, your primary responsibility will be to identify new business opportunities in clinical research, regulatory affairs, medical writing, and biostatistics. You will be tasked with developing and executing strategic sales plans to achieve revenue targets. Your role will involve managing the end-to-end sales cycle, from lead generation to contract closure. Building and maintaining strong relationships with clients will be crucial to your success in this position. You will lead client presentations, proposal development, and contract negotiations, acting as a single point of contact for key clients to ensure satisfaction and repeat business. Conducting market res...

Roles & Responsibilities: Preparation and timely update of Technical Files Regular updating of the Quality Manual Review and update of all relevant Standard Operating Procedures (SOPs) Review and revision of Work Instructions as per process requirements Preparation of Marketing Support Documents from QA perspective Review and update of internal Formats and Templates Periodic review and update of Site Master Files Must have working knowledge of various audits related to the medical device industry , including ISO 13485 , MDSAP, and CDSCO inspections

A. About the Role: Candidate should be able to assist in execution of assignments in Regulatory, Policy, Tariff, or Commercial related matters pertaining to Power Distribution Utilities. The person will be responsible for the preparation of Tariff Petitions along with Financial Models including power purchase portfolio FSA petitions and other commercial related petitions. Advising on the Amendments in the different Regulations, Acts, Policies, and Plan etc. and periodic review of regulatory developments in SERC / CEA/ MOP. Candidate will be responsible for providing comprehensive support to Power Distribution Utility in all day-to-day and routine regulatory matters pertaining to State Regula...

Filtrex Technologies Pvt. Ltd. As a part of the global industrial organization Marmon Holdings which is backed by Berkshire Hathaway you ll be doing things that matter, leading at every level, and winning a better way. We re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone s empowered to be their best. We are seeking a detail-oriented and proactive Regulatory Certification Engineer to maintain product certifications for the KX Technologies and Filtrex portfolios. This role ensures timely submission of certification applications, supports internal teams with regulatory guidance, and contri...

Responsibilities: * Prepare CDSCO dossiers & manage vendors * Conduct clinical research, formfilling expertise required * Ensure compliance with regulatory standards * Manage SUGAM portal submissions have experience in indian regulatory