2122 Regulatory Affairs Jobs - Page 26

We are looking for a skilled Associate Process Manager to join our team at eClerx Services Ltd., responsible for managing the KYC process. The ideal candidate will have a strong background in IT Services & Consulting, with excellent leadership and management skills. Roles and Responsibility Manage and oversee the KYC process to ensure compliance with regulatory requirements. Develop and implement process improvements to increase efficiency and reduce costs. Collaborate with cross-functional teams to identify and mitigate risks. Analyze data and metrics to optimize processes and improve customer satisfaction. Train and guide team members on new processes and procedures. Monitor and report on ...

We are looking for a highly skilled and experienced Analyst to join our team in the IT Services & Consulting industry. The ideal candidate will have 6-9 years of experience in KYC analysis. Roles and Responsibility Conduct thorough analysis of customer data to identify potential risks and ensure compliance with regulatory requirements. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to resolve complex issues and improve overall process efficiency. Provide expert guidance on KYC procedures and best practices to junior team members. Stay up-to-date with industry trends and regulatory changes to ensure the organiza...

We are looking for a skilled Associate Process Manager to join our team at eClerx Services Ltd., responsible for managing the Know Your Customer (KYC) process. The ideal candidate will have a strong background in IT Services & Consulting, with excellent analytical and problem-solving skills. Roles and Responsibility Manage and oversee the KYC process to ensure compliance with regulatory requirements. Develop and implement process improvements to increase efficiency and reduce errors. Collaborate with cross-functional teams to resolve issues and enhance customer experience. Analyze data and metrics to identify trends and areas for improvement. Implement risk management strategies to mitigate ...

Role & responsibilities REACH Registration of new product in EU, Korea, Turkey & UK, including tonnage upgradation, Invoicing, data collection from Inhouse, R&D / external lab, preparing REACH compliance/tonnage letter. Handling Questionnaire of customer which includes document related to product and factory. Providing declaration & certification for the same. Renewal documentation for Halal, Kosher, FSSAI, RSPO, NSF based on expiry including its surveillance. Renewal of Water testing reports (IS10500 and IS 4251), Nutritional analysis, annual return of FSSAI filing. Conducting Internal Audit as an auditor of ISO 9001:2015. Declaration based on Customer request/ Logistic team and solving que...

Exp:- 3 to 5yrs Work Location :- Bangalore(EC) Work closely with Product Compliance Business and IT resources to establish robust processes and design to support business needs and initiatives. Align with Business Process Owner on requirements and long-term direction of Business Process Design and maintenance of business processes and data (business architecture) Business Process Management and continuous improvement of process landscape Prioritizing and managing change for processes and data in alignment with the business. Discovering useful data insights, suggesting conclusions, and supporting decision making Closely aligns with technical subject matter expert for related IT systems to ens...

Educational Requirements Master Of Engineering,MTech,Bachelor of Engineering,BTech 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 y...

To drive sales and ensure business targets are achieved o Aggressively drive the sales numbers and achieve the business targets for Retail loan products and through cross selling while continuing to enhance and upgrade the client relationships.o Retain and expand the company's base of customers for retail loan product so as to ensure repeat business or referralso Maximize sales through a network and relationships to ensure strong businesso Develop and maintain strong liaisons with the clients for repeat business or referrals.o Ensure the files are processed from login stage to disbursement and liaise with internal departments (Operations and Credit) for completion.o Optimize team productivit...

Our Ideal Candidate: Our ideal candidate will typically be expected to demonstrate the following attributes: Good technical knowledge in Oracle Cloud Infrastructure Knowledge & working experience in ExaCS Understanding of Technical architecture landscape Should have a strong customer facing skills Ability to multitask, maintain composure in high-stress/high-visibility situations and change priority as needed to accommodate very dynamic business. Excellent team player, willing to learn new technologies Strong organization skills, detail oriented & communication skills. . University degree, with post graduate technical or management qualifications or other relevant experience. OCI Certified / ...

Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness Minimum Level of Education: Bachelors / Masters in Pharmaceuticals and/or Lifesciences and/or Food Technology Preferred Education: Masters/PhD in Pharmaceuticals and/or Lifesciences and/or Food Technology Minimum 5 years experience in handling regu...

You will be working as an Associate Manager / Manager in Business Development with Meteoric Biopharmaceuticals, a company driven by innovation through discovery for close to 2 decades. The headquarters are based in India, with strategic offices in the USA and Vietnam. The company serves clients across diverse industries worldwide, with a customer base exceeding 1000+ customers across 120+ countries. Meteoric Biopharmaceuticals is known for offering a wide range of biological solutions including Enzymes, Probiotics, Bioactives, Formulations, and Animal Health Care. The company also provides unique services like Product Customization, Concept Formulation, and Contract Manufacturing. Your respo...

As a Team Lead for Downstream Process development of Vaccines, your primary responsibility will be to achieve R&D development targets in alignment with organizational and market requirements. You will be managing the planning, implementation, and management of R&D development methods for new products and technologies, encompassing both upstream and downstream methods for large scale Bacterial & Viral Vaccine Production. Your role will require you to be a subject matter expert in Bacterial & Viral Vaccine Process development, possessing a thorough knowledge of downstream processes for vaccines and staying informed about current developments in the vaccine industry. You should be competent in ...

As a Quality Control Reviewer at TAPI, you will play a crucial role in ensuring the quality and compliance of our pharmaceutical products. Your primary responsibilities will include reviewing various documents such as batch records, test results, deviations, and corrective actions to determine the disposition of batches. You will also be responsible for monitoring manufacturing and packaging processes, investigating any errors or deviations, and implementing corrective and preventive actions as necessary. Your role will involve collaborating with internal and external stakeholders to address quality and compliance issues, facilitate batch reviews, and ensure the timely shipment and receipt o...

As a Drug Regulatory Affairs Manager at Covalent, you will be responsible for leading the Global Regulatory Project Team, comprising internal team members and external partners, to ensure the planning, preparation, and delivery of both simple and complex regulatory submissions and response documents on a global and regional scale. This includes maintaining core labeling documents, corporate approval of EU SmPC and US PI, and ensuring consistency with internal standards and SOPs. Your role will involve liaising with internal functions and external partners, leading cross-functional delivery teams, identifying regulatory risks, supporting routine and non-routine interactions with health author...

Leading pharmaceutical company requires Sr Executive( Regulatory affairs)- Mehemdabad( Gujrat) We are looking out for Sr Executive ( Regulatory affairs) for our client office in Mehemdabad( Gujrat) PFB the JD and details- Job Description Role- Sr Executive- Regulatory Affairs Location: Mehemdabad Experience- 5-9 years of relevant experience preferably in Healthcare/pharma industry CTC: Competitive Joining - maximum 30 days or less Key Responsibilities: Designation:Regulatory affairs -Executive/ Sr. Executive Job Type:Full time Job Summary: The primary responsibility for the position is to oversee the daily activities of the Regulatory Affairs. Ensure that deliverables are being met based on ...

As a Safety Aggregate Reporting Manager, you will act as a stand-alone global functional lead for Safety Aggregate Report and Analytics (SARA) Center deliverables. Your responsibilities will include leading, authoring, and finalizing various aggregate reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and responding to regulatory inquiries. You will also be involved in literature surveillance, signal management activities, and benefit risk management documents. In this role, you will play a key role in setting up, implementing, and leading safety management teams for post-marketing and clinical trial projects. You will be responsible for overseeing signal detection...

As a Regulatory Affairs Manager specializing in CMC, you will be responsible for leading and managing all CMC regulatory activities related to USFDA submissions, specifically focusing on ANDA preparation, review, and filing. Your role will involve overseeing the compilation and timely submission of Annual Reports, amendments, and responses to deficiencies. You will collaborate with cross-functional teams such as Quality Assurance, Production, and R&D to gather the necessary documentation and data required for regulatory submissions. A significant aspect of your responsibilities will include reviewing and ensuring compliance of Batch Manufacturing Records (BMR), process validation documents, ...

As the companys subject matter expert on drug safety and pharmacovigilance, you will be responsible for ensuring compliance with Local & Global PV-relevant Heath Authority requirements. Your role will involve overseeing PV Contracts, vendor management, and PV system audits/inspections. Additionally, you will develop a good understanding of signal management and benefit-risk evaluation activities. You will be expected to develop and implement Risk Management Plans (RMPs) and additional Risk mitigation measures. Acting as the primary safety liaison with country regulatory authorities and internal stakeholders will be a key part of your responsibilities. Collaboration with Clinical Development,...

You should have a good understanding of product development activities for various injectable dosage forms intended for the regulated market, including general injectable and onco products. Knowledge of ANDA and 505b2 product filing is essential. Familiarity with a wide range of dosage forms such as liquid solution, lyophilized, suspension, and emulsion is required. You should also be well-versed in drug device combination products and understand regulatory expectations. Experience with equipment like high shear homogenizer, high pressure homogenizer, lyophilizer, microfluidizer, and nano mill is preferred. Your responsibilities will include preparing and reviewing product development report...

The NFR Audit and Regulatory Associate is a valuable member of the NFR Audit and Regulatory team, providing support for various activities within the NFR organizations. These activities include Cyber and Technology Risk, Third Party Risk, Data Risk, New and Changing Business Activities, Risk Treatment and Reporting, Risk Quantification, Operational Risk, Operational Resilience, Fraud, Privacy, and Insider Threat. Your primary responsibilities will encompass data collection, document management, engagement timeline tracking, program documentation library and SharePoint maintenance, status report updating, document review and packaging, deliverable status tracking, status updates provision, an...

We are seeking a highly motivated and detail-oriented Quality Management System (QMS) professional to join our Quality Assurance team at Mendine Pharmaceuticals Pvt Ltd. As a part of our team, you will play a crucial role in ensuring compliance with regulatory requirements and company standards by implementing and maintaining effective quality management systems. Your responsibilities will include managing various quality-related activities such as quality risk management, batch manufacturing record preparation, process validation, deviation management, and more. In your role, you will be expected to identify, assess, and mitigate quality risks associated with products and processes. You wil...

You will be responsible for providing analytical support for developmental projects/comparative dissolution projects received from client sites. This includes being an interface with contract laboratories, suppliers, customers, and peers to define and improve project performance and expectations. You will coordinate with CRO to ensure that projects are completed within the timeline. Additionally, you will design scientific experiments, monitor lab work, and recommend further investigations based on experimental results. Your role will involve the preparation of test methods, technical documents, protocols, and reports when necessary. It is crucial to record information accurately, retain rec...

The Senior Associate Regulatory Project & Resource Management plays a crucial role in supporting and streamlining regulatory projects within the organization. You will be responsible for coordinating various tasks related to regulatory submissions and compliance, ensuring that projects are completed within set timeframes while adhering to stringent industry standards and regulations. This role is perfect for individuals with exceptional attention to detail and strong project management skills. Working closely with cross-functional teams, you will allocate resources efficiently and manage communication streams to ensure precise and timely compliance with regulations. This position offers sign...

About Us: At Artixio, we support global pharmaceutical, biologics, and medical device companies in navigating complex regulatory landscapes. We are seeking a detail-oriented and driven Data Associate to support our regulatory information management initiatives by organizing, maintaining, and updating critical regulatory data and documentation. Key Responsibilities: Collect, review, and organize regulatory data from public health authority sources (e.g., US FDA, EMA, CDSCO, HSA, TFDA, NPRA, etc.). Extract and compile information on product approvals, classifications, guidelines, and regulatory requirements across markets. Maintain and update regulatory databases, trackers, and internal docume...

About Freyr Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance. Why Freyr At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services. Join Our Team: If you&aposre ready to embark on a journey of growth and innov...

Key Responsibilities Intelligence Gathering & Analysis Monitor and analyze the global regulatory landscape for assigned therapeutic or regional areas Compile and synthesize new or updated regulatory requirements from local affiliates Prepare deliverables such as monitoring reports, bulletins, and landscape summaries Ensure outputs are clear, actionable, and aligned with business needs Provide insights or recommendations to inform filing strategies and compliance planning Tools & Data Management Manage and maintain regulatory intelligence tools, databases, and repositories Ensure systems are up-to-date and easily accessible by stakeholders Build or configure new dashboards, tracking tools, or...