303 Regulatory Guidelines Jobs - Page 8

As a diligent and detail-oriented Quality Control Analyst, you will be an integral part of our QC team. Your primary responsibility will involve conducting various tests on raw materials, in-process samples, and finished cosmetic products to ensure they adhere to predefined quality and safety standards. Your role will be crucial in upholding compliance with regulatory guidelines and maintaining consistent product quality. Your key responsibilities will include performing physical, chemical, and microbiological testing on raw materials, packaging materials, bulk, and finished products. You will also be accountable for preparing, reviewing, and maintaining accurate records of test results, reports, and batch analysis. Additionally, you will conduct stability testing, report any deviations or non-conformities, and ensure the calibration, cleanliness, and maintenance of laboratory instruments and equipment. It will be essential for you to comply with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). You will also be required to investigate and document any out-of-specification (OOS) results or product complaints. Collaborating with the production and R&D teams to resolve quality-related issues will be part of your responsibilities. Furthermore, staying informed about relevant quality regulations such as ISO, FDA, BIS, etc., and assisting in internal audits and regulatory inspections will be crucial aspects of your role. This is a full-time position that offers benefits including health insurance and life insurance. The work location is in person, and the application deadline is set for 25/07/2025.,

A leading NBFC company is keen to hire a Qualified CA for the Compliance Assistant/Deputy Manager to lead and enhance the internal audit and compliance framework by conducting risk-based audit & identify gaps to ensure timely resolution. Required Candidate profile -3+yrs exp in banks/ NBFC Co. for process review, risk Assessment, Internal controls -Hands-on with compliance monitoring tool -RBI regulations for NBFC or banking Industry -good communication skills

You are a motivated and client-focused Wealth Management Associate / Advisor who is interested in joining a financial advisory team in Trivandrum, Kerala. You should have 2 to 5 years of experience in wealth management, investment advisory, or financial planning, and possess a strong understanding of financial markets, portfolio strategies, and client relationship management. Your responsibilities will include assisting clients in managing and growing their investment portfolios based on their financial goals and risk appetite, providing personalized wealth management solutions such as mutual funds, insurance, bonds, equities, and other financial products, conducting periodic portfolio reviews, staying up-to-date with market trends and regulatory guidelines, collaborating with internal teams for client onboarding and compliance checks, building and maintaining long-term client relationships, achieving business targets, and organizing client meetings, webinars, and financial literacy sessions. To excel in this role, you should have 2 to 5 years of experience in wealth management, financial planning, or investment advisory, along with certification in NISM (Investment Adviser / Mutual Fund Distributor). Knowledge of investment products, taxation, insurance, and risk assessment tools is essential, as well as strong interpersonal, communication, and relationship-building skills. Proficiency in CRM tools, MS Office, and financial planning software is required, along with high integrity, ethical standards, and a client-centric mindset. Having certifications such as CFP, CFA (Level 1), or other financial planning credentials would be advantageous, along with exposure to HNI/UHNI client management and experience with digital wealth platforms and tools. If you are ready to shape the financial future of clients and meet the qualifications mentioned above, please apply now by sending your CV to: fawas.m@ixiligence.com. This is a full-time position that requires in-person work in Trivandrum, Kerala.,

The ALM Specialist within the Retail Risk department is responsible for supervising the development of the bank's balance sheet with a focus on funding, liquidity, and capital, to assess liquidity risk exposure in alignment with established risk appetite. The key responsibilities of the role include: - Identifying, assessing, measuring, and monitoring risks related to ALM, such as interest rate, equity, foreign exchange, credit, and liquidity risks. - Providing recommendations, implementing, and updating ALM measurement and reporting metrics as outlined in the ALM framework. - Maintaining a clear understanding of the bank's Risk Management Policies associated with ALM, including investment policies, risk appetite, and stress testing, to support ALM requirements. - Collaborating with Financial Control to develop gap statements for liquidity and profit rate sensitivity, as well as regulatory submissions. - Developing liquidity contingency plans, evaluating ALM limits adequacy, and proposing liquidity risk appetite for management review and action. - Analyzing financial statistical data both quantitatively and qualitatively to inform decision-making processes. - Ensuring strict compliance with RBI and other regulatory guidelines. - Establishing an effective documentation system for storage and retrieval of information. - Overseeing the preparation of timely and accurate liquidity risk MIS statements and reports to meet bank and function requirements, policies, and standards. - Presenting insights, findings, and recommendations through reports and presentations to drive improvements. - Staying updated on the latest market intelligence, benchmarking against competitor banks" best practices, and sharing knowledge within the team. - Recommending process and policy enhancements across Retail Banking to enhance operational efficiencies and customer service quality. - Collaborating with internal stakeholders to leverage in-house synergies. - Fostering a collaborative learning environment and promoting collective ownership of responsibilities within the team. Educational Qualifications: - Graduate: Any - Post Graduate: Any Experience: - 7+ years of relevant experience,

As the Feasibility Lead in Clinical Trials, you will be responsible for managing and delivering comprehensive feasibility assessments for early-phase clinical trials. Your role will involve ensuring the scientific, operational, and regulatory viability of proposed sites and countries, as well as supporting proposal development through collaboration with internal stakeholders and external clients. You will lead feasibility planning and execution to support project bids and early engagement efforts. Additionally, you will drive data-driven site and country selection strategies and serve as the subject matter expert in feasibility best practices to ensure alignment with global regulatory requirements. In terms of subject matter leadership, you will provide strategic input on protocol design, country, and site selection, stay updated on global feasibility trends and regulatory guidelines, and guide teams on interpreting feasibility data in line with business objectives. Moreover, you will contribute to process improvement initiatives and knowledge sharing activities within the organization. Your role will also involve project execution, where you will lead feasibility components across multiple projects to ensure timely and high-quality deliverables. You will be expected to anticipate challenges, design mitigation strategies proactively, and optimize internal resources to manage feasibility timelines effectively. Reporting and documentation will be a key aspect of your responsibilities. You will develop and present regular updates, dashboards, and ad hoc reports for both internal and external stakeholders. It is essential to maintain clear records for audits and client reviews to ensure transparency and compliance. Quality assurance is another crucial area where you will be involved. You must ensure compliance with ICH-GCP, company SOPs, and regulatory frameworks, participate in internal audits, and implement corrective actions as necessary. Promoting a culture of quality and continuous improvement will be integral to your role. Process optimization is also part of your responsibilities. You will contribute to the creation and refinement of SOPs related to feasibility, identify inefficiencies, and recommend enhancements to improve scalability and consistency within the organization. Team development and collaboration are essential components of this role. You will support the onboarding and mentoring of new or junior team members, foster a collaborative work environment, and facilitate cross-functional knowledge sharing. Additionally, participating in resource planning discussions to support strategic growth will be expected. Key Performance Indicators (KPIs) for this role include the timeliness and accuracy of feasibility reports, the success rate of project bids supported, client satisfaction in feasibility discussions, compliance with SOPs and regulatory requirements, contribution to team development and knowledge sharing, as well as clarity and transparency in feasibility reporting. Internal and external collaboration are critical aspects of this role. You will collaborate with department and functional heads internally (e.g., BD, Clinical Operations, Regulatory) and externally with sponsors, clients, and Global Site Networks. Candidate Requirements: - Education: Bachelor's degree in Pharmacy (mandatory); higher degrees in life sciences or clinical research are a plus. - Experience: Minimum 8 years of relevant experience in clinical trial feasibility or clinical development, with exposure to feasibility planning for early-phase clinical trials (Phase I/II) and global clinical trials preferred. - Technical Competencies: Strong understanding of clinical development and regulatory landscapes, proficiency in feasibility platforms, site databases, and data analytics tools, as well as CRM tools and Microsoft Office Suite (Excel, PowerPoint, Outlook). - Behavioural Competencies: Strong decision-making and problem-solving abilities, effective communication and interpersonal skills, coaching and mentoring mindset, ability to collaborate across functions and lead without direct authority.,

As the Policy Formulation and Compliance specialist, you will be responsible for leading the formulation, review, and periodic updates of Policies and risk guidelines. It is crucial to ensure that these policies are in alignment with regulatory requirements, market trends, and internal risk appetite. Your role will also involve integrating and enhancing systems for the effective implementation of these policies. Working closely with audit and compliance teams will be essential to ensure adherence to regulatory guidelines. Standardizing risk assessment procedures across products and business lines will also fall under your purview. Furthermore, you will be tasked with ensuring periodic reviews and updates of policies based on risk events, business changes, or regulatory updates. Collaboration with business teams will be necessary to embed policies into lending workflows and ensure compliance at all levels. In the realm of Risk Analytics and Risk Systems Management, you will lead data-driven analysis of portfolio risk trends and potential exposures. This will involve coordinating with analytics to prepare various management dashboards and tools for portfolio monitoring. Additionally, you will support the implementation and maintenance of risk assessment and monitoring tools, such as credit scoring models and portfolio monitoring tools. Your expertise in analyzing trends using risk metrics like DPD, buckets, NPA levels, and write-offs will be instrumental in enhancing risk management processes.,

As a QA Assistant Manager with 5-7 years of experience in the pharmaceutical industry, you will be responsible for running the department independently. Your role will require strong skills in inter and intra-departmental communication, a desire to learn, and the ability to adapt and adopt to people and systems effectively. This position is based in Mumbai. Your key responsibilities will include: - Skilled handling of FDA-GMP audits to ensure compliance with regulatory standards. - Experience in establishing robust Quality Management Systems (QMS) to ensure compliance with GLP and cGMP standards. - Expertise in creating, reviewing, and maintaining Standard Operating Procedures (SOPs). - Managing and implementing change control processes effectively. - Proficient in preparing and maintaining Site Master Files, Master Validation Plans, and Batch Manufacturing Records (BMRs). - Conducting stability studies, managing stability programs, and handling Out of Trend (OOT) and Out of Specification (OOS) results. - Establishing and maintaining standards according to current regulatory guidelines and Pharmacopeia revisions. - Evaluating deviations, managing change controls, and implementing corrective and preventive actions (CAPA). - Proficient in equipment qualification, process validation, cleaning validation, and method validation. - Overseeing the calibration of equipment and adhering to ICHQ7A guidelines and other regulatory standards. - Conducting trend analysis, providing feedback for continuous improvement, and implementing Quality Risk Management strategies. - Working towards continuous improvement of quality systems and efficiently managing Quality Control departments. - Handling ISO documentation procedures, including quality manuals, work instructions, checklists, and audits. - Managing sampling and testing of excipients, Essential Oils, and Aroma chemicals. - Strong skills in effective manpower handling and communication in English, both oral and written. This is a full-time position with benefits including Provident Fund. The work schedule is day shift, and the work location is in person.,

As an In Vivo PK scientist at Syngene, your primary responsibility will be to conduct in vivo pharmacokinetics studies in rodents. With 5-8 years of post-qualification experience and a background in M. Pharm or M.V. Sc. (Pharmacology & Toxicology), you will play a crucial role in documenting lab notebooks online, managing compounds, and ensuring compliance with environment, health, and safety (EHS) practices. Your role will involve conducting pharmacokinetic studies in rodents, preparing study protocols and reports for submissions, and analyzing pharmacokinetic data using tools like Phoenix WinNonlin. You should be well-versed in surgical procedures such as cannulation of jugular, femoral, and portal veins in rats, as well as the collection of vital organs during tissue distribution studies. In addition to your technical skills, you are expected to be a team player with a willingness to take on new challenges, demonstrate commitment to work and timelines, and maintain a learning attitude. Strong communication skills and a proactive approach to work are essential for success in this role. At Syngene, safety is of utmost importance, and you will be required to adhere to safety protocols and EHS requirements at all times to ensure individual and lab/plant safety. By championing effective EHS practices and fostering a culture of excellence, integrity, and professionalism, you will contribute to Syngene's core values and commitment to quality and compliance. If you are a motivated individual with a passion for pharmacokinetics and a dedication to safety and quality standards, this role offers an exciting opportunity to make a significant impact in the field of in vivo PK studies.,

Role & responsibilities Review and approve Finished Goods and corresponding Certificates of Analysis (COA). Maintain detailed records of received samples in an organized manner. Ensure proper allocation and storage of approved COAS in the shared drive. Verify and confirm drug product permissions as per regulatory requirements. Oversee the finalization of packing materials in coordination with relevant departments. Conduct audits of new vendors, ensuring compliance with quality standards. Ensure proper implementation of Corrective and Preventive Actions (CAPA) for any deviations or complaints. Visit manufacturing sites to address and investigate market complaints effectively. Coordinate with manufacturing partners for handling market and sample-related complaints. Perform joint analysis of complaint samples in collaboration with manufacturers to identify root causes. Maintain strict adherence to Good Documentation Practices (GDP). Possess sound knowledge of Schedule M, USFDA, MHRA and ensure compliance in relevant activities. Sound knowledge of IPQA (In-Process Quality Assurance) activities across different dosage forms (e.g., tablets, capsules, syrups, ointments, etc.) Sound knowledge of different types of SOPS (Standard Operating Procedures), including preparation, review, implementation, and compliance monitoring. Basic understanding of QMS (Quality Management System), including its elements and relevance in pharmaceutical operations.

Role & responsibilities Review and approve Finished Goods and corresponding Certificates of Analysis (COA). Maintain detailed records of received samples in an organized manner. Ensure proper allocation and storage of approved COAS in the shared drive. Verify and confirm drug product permissions as per regulatory requirements. Oversee the finalization of packing materials in coordination with relevant departments. Conduct audits of new vendors, ensuring compliance with quality standards. Ensure proper implementation of Corrective and Preventive Actions (CAPA) for any deviations or complaints. Visit manufacturing sites to address and investigate market complaints effectively. Coordinate with manufacturing partners for handling market and sample-related complaints. Perform joint analysis of complaint samples in collaboration with manufacturers to identify root causes. Maintain strict adherence to Good Documentation Practices (GDP). Possess sound knowledge of Schedule M, USFDA, MHRA and ensure compliance in relevant activities. Sound knowledge of IPQA (In-Process Quality Assurance) activities across different dosage forms (e.g., tablets, capsules, syrups, ointments, etc.) Sound knowledge of different types of SOPS (Standard Operating Procedures), including preparation, review, implementation, and compliance monitoring. Basic understanding of QMS (Quality Management System), including its elements and relevance in pharmaceutical operations.

A leading NBFC company is keen to hire a SQ/Q - CA/CS for the Compliance Manager (Internal auditor) to lead and enhance the internal audit and compliance framework by conducting risk-based audit & identify gaps to ensure timely resolution. Required Candidate profile -3+yrs exp in banks/ NBFC Co. for process review, risk Assesment, Internal controls -Hands-on with compliance monitoring tool -RBI regulations for NBFC or banking Industry -good communication skills

About Credit Saison India Established in 2019, Credit Saison India is one of the country's fastest-growing Non-Bank Financial Company (NBFC) lenders, with verticals in wholesale, direct lending, and tech-enabled partnerships with Non-Bank Financial Companies (NBFCs) and fintechs. Its tech-enabled model, coupled with underwriting capability, facilitates lending at scale, meeting India's significant gap for credit, especially with underserved and underpenetrated segments of the population. Credit Saison India is committed to growing as a lender and evolving its offerings in India for the long term, focusing on MSMEs, households, individuals, and more. It is registered with the Reserve Bank of India (RBI) and holds an AAA rating from CRISIL (a subsidiary of S&P Global) and CARE Ratings. Currently, Credit Saison India has a branch network of 45 physical offices, 1.2 million active loans, an AUM of over US$1.5 billion, and an employee base of about 1,000 people. Credit Saison India (CS India) is part of Saison International, a global financial company with a mission to bring people, partners, and technology together, creating resilient and innovative financial solutions for a positive impact. Across its business arms of lending and corporate venture capital, Saison International is committed to being a transformative partner in creating opportunities and enabling the dreams of people. Based in Singapore, over 1,000 employees work across Saison's global operations spanning Singapore, India, Indonesia, Thailand, Vietnam, Mexico, and Brazil. Job Summary: We are seeking a data-driven and strategic professional to lead our collection strategy for retail and SME loans in India. The ideal candidate will develop, implement, and optimize debt collection strategies that improve recovery rates, reduce delinquency, and ensure compliance with regulatory guidelines. The role requires a strong understanding of analytics, collection processes, RBI regulations, and customer segmentation. Key Responsibilities: Strategy Development: Design and implement end-to-end collection strategies across delinquency buckets (soft, hard, and legal collections). Develop risk-based segmentation to prioritize accounts and personalize recovery actions. Optimize contact strategies (SMS, IVR, email, field visits, call center) based on customer behavior and risk profile. Portfolio Management: Monitor portfolio performance, delinquency trends, and recovery rates. Identify stress segments and design focused recovery campaigns. Analytics & Reporting: Use data analytics and machine learning models to forecast recoveries and predict roll rates. Work closely with the data science team to improve scoring models. Build dashboards and performance reports for senior management. Process Optimization: Drive automation and digitization of collections processes. Identify and fix bottlenecks in existing collection flows. Agency & Vendor Management: Onboard and manage third-party collection agencies and legal vendors. Define SLAs and ensure adherence to compliance and performance metrics. Compliance & Risk: Ensure adherence to RBI guidelines, fair practices code, and regulatory requirements. Mitigate reputational and operational risk through effective control mechanisms. Qualifications & Skills: Bachelors degree in Business, Finance, Economics, or related field; MBA preferred. 5-10 years of experience in debt collections, preferably in a fintech, NBFC, or bank. Experience in managing unsecured and secured loan portfolios. Strong knowledge of Indian regulatory framework (RBI, DRA guidelines, SARFAESI). Proficient in Excel, SQL, Power BI/Tableau; knowledge of SAS/R/Python is a plus. Excellent problem-solving, analytical, and communication skills. Experience in working with cross-functional teams (tech, legal, product, operations). Preferred: Exposure to collections strategy in digital lending or consumer finance. Experience with AI/ML-based collection scorecards or decision engines. Multilingual proficiency to deal with regional agencies across India.,

You will be joining KPMG in India, a professional services firm affiliated with KPMG International Limited since its establishment in August 1993. Leveraging a global network of firms, we provide services to national and international clients across various sectors with offices in multiple cities across India. As part of the Financial Crimes specialist team, your role will involve providing solutions to BFSI clients through model validation testing for AML risk models and frameworks, sanctions screening, and transaction monitoring systems. We are seeking individuals with advanced data science and analytics skills to support our team in addressing the challenges associated with financial crime. Your responsibilities will include but are not limited to supporting functional SME teams in building data-driven Financial Crimes solutions, conducting statistical testing of screening matching algorithms and risk rating models, validating data models of AML systems, and developing AML models to detect suspicious activities and transactions. You will collaborate with cross-functional teams to analyze data for model development and validation, prepare detailed documentation and reports, and assist in feature engineering for automation of AML-related investigations. To qualify for this role, you should have a Bachelor's degree from an accredited university, at least 3 years of hands-on experience in Python with knowledge of frameworks like Java, Fast, Django, Tornado, or Flask, experience with Relational and NoSQL databases, proficiency in BI tools such as Power BI and Tableau, and an educational background in Data Science and Statistics. Additionally, expertise in machine learning algorithms, statistical analysis, and familiarity with regulatory guidelines for AML compliance are essential. Preferred qualifications include experience in AML model validation, statistical testing of risk models, and familiarity with AML technology platforms. Hands-on experience with data analytics tools like Informatica and Kafka is also desirable. If you are looking to contribute your advanced analytics skills to combat financial crime and support leading financial institutions in adhering to industry best practices, this role offers you the opportunity to work on challenging projects and develop professionally in a dynamic environment.,

The Assistant Manager, Talent Acquisition will be responsible for finding, recruiting, and hiring best-in-class talent. You will maintain effective working relations with stakeholders and implement ideas for improving the Talent Acquisition process and outcomes. You will screen and source potential candidates through job portals to fulfill the firm-wide staffing needs by attracting and recruiting top-performing employees. Ensuring that the top talent in the market is selected through assessment of capabilities, experience, and potential as well as systematizing the screening process will be part of your responsibilities. You will conduct calibration meetings with stakeholders to help build their team by providing talent acquisition expertise. Creating content for various job and social media posts to correspond with candidates via email, calls, and in person while networking and interacting with a variety of people that are important in the recruitment process is also essential. As the face of the company to candidates, you will be the point of contact for hiring managers and a liaison between the two parties throughout the hiring process. Planning and scheduling interviews by managing logistical details and determining the time that suits all parties will be under your purview. You will be expected to minimize the TAT for closing roles by devising and implementing innovative pipeline strategies and efficient hiring strategies to meet defined KPIs. Managing offer formalities and overseeing the post-offer engagement process will also be part of your role. Ensuring defined processes are followed along with compliance and regulatory guidelines is crucial. Preferred candidates for this role are experienced in hiring for the IT/Tech/BFSI domain, possess attention to detail, excel in Excel and PowerPoint, maintain confidentiality of information, exhibit excellent interpersonal, decision-making, and communication skills, and have an extensive understanding of HR databases, applicant tracking systems, and candidate management systems. To be eligible for this position, you should have 5 to 8 years of relevant work experience and hold a graduate degree in any discipline. The compensation structure will be as per industry standards.,

As a Medical Writer II (Clinical Trial Transparency) at Syneos Health, you will play a crucial role in compiling, writing, and editing medical writing deliverables. Your responsibilities will include mentoring less experienced medical writers, developing various documents such as clinical study protocols, clinical study reports, patient narratives, annual reports, and investigator brochures with minimal supervision. You will review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. Collaboration with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs will be essential to produce high-quality writing deliverables. You will also serve as a peer reviewer to ensure scientific content accuracy, clarity, overall consistency, and proper format. Adherence to established regulatory standards, including ICH-E3 guidelines, Company Standard Operating Procedures, and client standards is paramount. Your role will involve performing online clinical literature searches, maintaining a working knowledge of the drug development process and regulatory guidelines, and continuing professional development to stay informed about regulatory guidance affecting medical writing. In this role, you will be expected to work within budget specifications for assigned projects and communicate any changes to medical writing leadership promptly. Completing required administrative tasks within specified timeframes and performing other work-related duties as assigned will be part of your responsibilities. Some minimal travel may be required, typically less than 25%. To qualify for this position, you should have a Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree in Social Sciences, English, or Communications with scientific and/or medical knowledge. Proficiency in English grammar, FDA and ICH regulations, and familiarity with AMA style guide is necessary. Effective presentation, proofreading, interpersonal, and leadership skills are essential for this role, along with a team-oriented approach. If you are passionate about making a meaningful impact in the field of medical writing and are eager to contribute to the development of cutting-edge therapies, Syneos Health offers a dynamic and supportive work environment where your contributions will be valued and recognized. Join us in our mission to accelerate customer success and transform lives through innovative medical writing practices.,

Veramed prides itself on providing the highest quality statistics and programming consultancy for its clients, and offering its employees an industry-leading working environment with support and training for career growth. We are seeking a hands-on Programmer with attention to detail and a strong work ethic to work as part of the statistical and programming team, providing programming support to a variety of clients in the Veramed portfolio. This role provides the opportunity to progress towards becoming a Lead Programmer at Veramed. This role entails a wide variety of responsibilities and client exposure - you are certainly not pigeonholed. Below is a range of the types of tasks you could be carrying out on a daily basis: As with many roles at Veramed, you have the opportunity to shape their direction dependent on client needs and your own career. Some key responsibilities include: - Developing and maintaining complex SAS programs for data manipulation, statistical analysis, report generation, and data visualization. - Utilizing advanced SAS procedures and techniques. - Managing and manipulating large datasets, including data cleaning, transformation, and integration from various sources. - Applying statistical methodologies and techniques to analyze data and interpret results. - Collaborating with statisticians and other team members on study design and analysis plans. - Creating high-quality reports, tables, and graphs to effectively communicate data insights. - Ensuring the accuracy and validity of SAS programs and output through rigorous quality control procedures. - Adhering to regulatory guidelines and industry best practices. - Providing technical guidance and mentorship to junior programmers. - Serving as a subject matter expert in SAS programming. - Collaborating effectively with cross-functional teams, including statisticians, clinicians, data managers, and other stakeholders. - Identifying opportunities to improve programming efficiency and streamline processes. - Developing and implementing programming standards and best practices. - Creating and maintaining clear and concise documentation for SAS programs and analyses. Required Skills: - Advanced proficiency in SAS programming language and various SAS procedures. - Strong understanding of statistical concepts and methodologies. - Experience with data manipulation, cleaning, and transformation techniques. - Ability to write efficient and optimized SAS code. - Excellent problem-solving and analytical skills. - Strong communication and interpersonal skills. - Ability to work independently and as part of a team. Opportunities For: - Development into lead programmer or technical role. - Gaining experience across different therapeutic areas and phases. - Presenting at conferences. - Peer mentoring and/or line management. - Developing innovative solutions to aid study reporting. - Contributing to initiatives that consider employees, the environment, and local communities as part of our B Corp accreditation.,

The Assistant Manager, Talent Acquisition will be responsible for finding, recruiting, and hiring best-in-class talent. You will maintain effective working relations with stakeholders and implement ideas for improving the Talent Acquisition process and outcomes. You will be responsible for screening and sourcing potential candidates through job portals to fulfill the firm-wide staffing needs by attracting and recruiting top-performing employees. Ensuring that the top talent in the market is selected through assessment of capabilities, experience, and potential as well as systematizing the screening process will be part of your responsibilities. You will conduct calibration meetings with stakeholders to help build their team by providing talent acquisition expertise. Creating content for various job and social media posts to correspond with candidates via email, calls, and in person while networking and interacting with a variety of people that are important in the recruitment process is essential. You will act as the face of the company to candidates, the point of contact for hiring managers, and a liaison between the two parties throughout the hiring process. Planning and scheduling interviews by managing logistical details and determining the time that suits all parties will also be your responsibility. To minimize the TAT for closing roles, you will devise and implement innovative pipeline strategies and efficient hiring strategies to meet defined KPIs. Managing offer formalities, overseeing the post-offer engagement process, ensuring defined processes are followed, and adhering to compliance and regulatory guidelines are critical tasks. Preferred candidates for this role are experienced in hiring for IT/Tech/BFSI domain. Attention to detail, excellent command of Excel and PowerPoint, maintaining confidentiality of information, excellent interpersonal, decision-making, and communication skills are prerequisites. Extensive understanding of HR databases, applicant tracking systems, and candidate management systems is required. You should have 5 to 8 years of relevant work experience and be a graduate in any discipline. The compensation structure will be as per industry standards.,

As a Clinical Evaluation Medical Writer at Medtronic, you will play a crucial role in developing and updating clinical evaluation documents to support CE Mark submissions and ensure compliance throughout the product lifecycle. Your work will involve close collaboration with cross-functional teams to gather and interpret data on device safety, performance, and benefit-risk according to MEDDEV 2.7/1 Rev. 4 and EU Regulation 2017/745. You will also be responsible for summarizing and disseminating clinical literature and other available data to share relevant evidence, while managing Medical Information activities. This includes tracking inquiries, monitoring key metrics, researching and responding to technical and clinical questions from internal teams and external healthcare professionals under the guidance of Clinical and Medical Affairs. Success in this role will require strong skills in scientific writing, literature review, data analysis, and clear communication, as well as a proactive and collaborative mindset. Your responsibilities may include independently creating and maintaining clinical evaluation documents in compliance with relevant regulations and company procedures, supporting Medical Information activities by responding to inquiries, conducting literature searches and reviews, reviewing scientific materials for accuracy and compliance, developing reports, identifying and reporting complaints or adverse events, and collaborating with key stakeholders to drive evidence-based scientific decisions. To excel in this position, you are required to have a mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. A Baccalaureate degree and a total of 8 years of experience with a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience are also required. Medtronic offers a competitive salary and flexible benefits package as part of its commitment to employees. The company values the contributions of its employees and offers various benefits, resources, and competitive compensation plans designed to support you at every career and life stage. The position is also eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). Medtronic is a global leader in healthcare technology that aims to address the most challenging health problems facing humanity by seeking out innovative solutions. With a mission to alleviate pain, restore health, and extend life, Medtronic unites a global team of passionate individuals who are committed to making a difference. The company values diversity and is dedicated to engineering extraordinary solutions for real people by leveraging talent, diverse perspectives, and ambitious ideas. To learn more about Medtronic's business, mission, and commitment to diversity, please visit their website.,

Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical data and escalates for resolution. Thorough knowledge and experience of drug development practice, rules, regulations, and guidelines. Demonstrates knowledge of key processes, procedures and tools. Regulatory Skills: Strong knowledge on the Regulatory requirements during both development and life-cycle management phases for US, Europe and other major markets and has expertise to oversee preparation and submission of complex regulatory submissions. Knowledge on current regulations and filings requirements for post approval. Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape. Adequate level of knowledge on general standards SOP, processes and policies of Pharma industry. Leadership Skills: Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format. Ability to comprehend and summarize complex technical data. Ability to utilize flexible approaches to negotiate skillfully in tough situations with both internal and external groups. Gains trust quickly with cross functional team to the negotiations.

About Retail Portfolio Management Group The RPMG department focuses on the collections for lending business of the bank including Retail, Rural and Agri and SME Businesses among others. They also provide recovery resolutions for working capital loans and Business loans for Small Businesses and is also responsible for the receivables/collections business of the bank. About the Role The Compliance and Risk Officer (CARO) Team is responsible for ensuring the risk and compliance culture within the Retail Portfolio Management Group. Role of CARO function involves taking steps and corrective actions, wherever required, so that the processes within the department are compliant with the regulatory guidelines. Also, CARO team ensures mitigation of potential risks associated with the functions of the department through effective controls. Any gaps in processes or controls are identified and addressed by CARO either by strengthening existing controls or by designing new ones. In addition to this, CARO is also responsible for formulating management action plan (MAP) for internal audit observations, Risk Assessment Review reports resulting from RBI audit, ensuring housekeeping parameters such as review/ renewals, internal rating, EWS and RFA triggers, pending security creation, etc. are within the minimum thresholds, providing regular updates to Senior Management on status of implementation of Risk Mitigation Plan advised by RBI, sharing any new or changes in regulatory guidelines with all members of the department and ensuring facilitation of Compliance testing and RAR sustenance testing by Compliance department. For all the above function CARO team is required to coordinate across cross-functional departments such as Operational Risk, Compliance, Credit Risk, CBO, IAD and F & A. Key Responsibilities Respond to RBI queries during annual RBS audit. Co-ordinate for all the activities related to Risk Based Supervision / other regulatory inspections including the submission of data / documents and represent the department for all the queries raised during the RBI inspections. Formulate responses to RAR observations from RBI in coordination with various Business Segments and Credit Underwriting. Keep abreast with the regulatory changes and ensure dissemination and Implementation of regulations / amendments / actionable/ compliance communication in line with the milestones committed and within the timelines prescribed by regulators / internal timelines. Supervise activities of CARO team members which includes various financial reporting. monitoring of Key Risk Indicators and Key Compliance Indicators, assessment of all Risks and associated control, timely and vetted response of regulatory/ statutory correspondence to Compliance Department for onward submission, facilitation of Operational Risk and Financial Risk walkthrough, Remediation of operational risk issues and control gaps, responses to audit observations. Design new processes/ controls to address gaps highlighted by Operational Risk after risk assessment exercise and IAD after audit review. Review of Policies pertaining to Retail Lending and Collections in alignment with the regulatory guidelines Monitoring the Compliance Risk / Operational risk dashboards / risk movements of assessment units and flagging of the concerns to Head of the Department. Monitor parameters such as review/ renewals, internal rating, EWS and RFA triggers, pending security creation, etc. and ensure they are done within due dates so that the overdue cases are within the minimum thresholds, Provide regular updates to Segment Heads and Senior Management on status of implementation of Risk Mitigation Plan advised by RBI through weekly dashboards and bi-monthly RMP meeting with all Department Heads and MANCOM members. Preferred candidate profile Optimal qualification for success on the job is: Education (CA / MBA from Tier 1 Institute) Experience (~12-15 yrs in Banks Retail Credit, Collections, Compliance or Internal Audit for Retail Lending, Risk ) Role Proficiencies: In-depth knowledge of key drivers and indicators in the relevant sectors A solid understanding of financial statements, ratios Understanding of compliance, regulatory norms and operating procedures Good relationship management and strong communication and presentation skill

Compliance Team Member - Treasury Department Compliance Location Mumbai Number of Positions 1 Reporting Relationships Reporting to Deputy Vice President(M6) Position Grade Senior Manager(M4) The key responsibilities would include the following: Supporting the business/treasury function of the bank by giving advisory on all treasury related matters from Compliance Perspective. Supporting the team lead in reviewing Treasury related Products, Policies, Processes and notes. It involves providing compliance advisory and feedback giving feedbacks and advice to ensure the bank processes are comprehensive and compliant with regulatory guidelines. Advising on all matters relating to Market risk. Review and support the team lead in advising/reviewing all Statutory Audit Related Certificates. Advising on all matters relating to Finance including Disclosures in financial statements related to Investment, Borrowing, Derivative, Market risk, Liquidity risk etc. Collaborating with other assurance functions like risk and internal audit for regulatory matters. Carrying out select testing and monitoring of regulatory risk areas of treasury to ensure compliance with RBI guidelines. Getting involved in implementation of new circular at Bank level on all treasury related matters. Assisting the team during the time of RBI Audit by co-ordinating and collaborating with stakeholders to provide information and details requested by RBI. Resolving the points raised by RBI in inspection reports including conducting root cause analysis for regulatory violations. Engage with regulators and support business stakeholder needs as and when required, to obtain clarity on the regulations and secure approvals where required. Supporting the team lead in business reviews, review of concurrent audit reports, preparation of MIS data etc. CA/MBA Degree Knowledge about key regulatory requirements relating to banking and financial services segment. Hands-on experience of implementing or monitoring implementation of regulations/ Prior audit or assurance background will be preferred. Ability to perform under pressure within the given time lines. Should possess good communication / interpersonal / problem solving skills and has to be a quick learner. Diligent, hard-working & a team player, with ability to drive outcomes when working with other stakeholders. Proficient in working on MS Office tools

Compliance Team Member - Treasury Department Compliance Location Mumbai Number of Positions 1 Reporting Relationships Reporting to Deputy Vice President(M6) Position Grade Senior Manager(M4) The key responsibilities would include the following Supporting the business/treasury function of the bank by giving advisory on all treasury related matters from Compliance Perspective. Supporting the team lead in reviewing Treasury related Products, Policies, Processes and notes. It involves providing compliance advisory and feedback giving feedbacks and advice to ensure the bank processes are comprehensive and compliant with regulatory guidelines. Advising on all matters relating to Market risk. Review and support the team lead in advising/reviewing all Statutory Audit Related Certificates. Advising on all matters relating to Finance including Disclosures in financial statements related to Investment, Borrowing, Derivative, Market risk, Liquidity risk etc. Collaborating with other assurance functions like risk and internal audit for regulatory matters. Carrying out select testing and monitoring of regulatory risk areas of treasury to ensure compliance with RBI guidelines. Getting involved in implementation of new circular at Bank level on all treasury related matters. Assisting the team during the time of RBI Audit by co-ordinating and collaborating with stakeholders to provide information and details requested by RBI. Resolving the points raised by RBI in inspection reports including conducting root cause analysis for regulatory violations. Engage with regulators and support business stakeholder needs as and when required, to obtain clarity on the regulations and secure approvals where required. Supporting the team lead in business reviews, review of concurrent audit reports, preparation of MIS data etc. CA/MBA Degree Knowledge about key regulatory requirements relating to banking and financial services segment. Hands-on experience of implementing or monitoring implementation of regulations/ Prior audit or assurance background will be preferred. Ability to perform under pressure within the given time lines. Should possess good communication / interpersonal / problem solving skills and has to be a quick learner. Diligent, hard-working & a team player, with ability to drive outcomes when working with other stakeholders. Proficient in working on MS Office tools

Functional Responsibility Having sound knowledge of banking domain (Wholesale, retail, core banking, trade finance) In-depth understanding of RBI Regulatory reporting and guidelines including RBI ADF approach document. Should have experience in handling various important regulatory returns like Form- A, Form VIII (SLR), Form X, BSR, SFR (Maintenance of CRR) ,DSB Returns, Forex, Priority sector lending related returns to RBI Should have an understanding of balance sheet and P&L. Supporting clients by providing user manuals, trainings, conducting workshops and preparing case studies. Process Adherence Review the initial and ongoing development of product Responsible for documenting, validating, communicating and coordinating requirements. Provide support to business development by preparing proposals, concept presentations and outreach activities Maintaining and updating tracker, reviewing test cases, providing training to internal as well as external stakeholders Client Management / Stakeholder Management Interact with clients in relation to assignment execution and manage operational relationships effectively Interact with client for requirement gathering, issue tracking, change request discussion, FRD writing and preparing project status reports People Development Co-ordinate with assignment-specific team of consultants, developers, QA and monitor performance to ensure timely and effective delivery

Job Summary As a qualified candidate, you will be leading the Quality Assurance, QC Chemistry and Microbiology Laboratories for the site. Your role will involve developing Standard Operating Procedures (SOPs), ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines, and monitoring day-to-day department activities. Responsibilities include reviewing and approving documents, executing in-process controls, participating in investigations, vendor qualification, stability management, and ensuring safety practices. Roles & Responsibilities You will be responsible for organizing the recruitment and training of QA (Quality Assurance) and laboratory personnel for chemistry and microbiology laboratories. You will ensure adherence to systems and procedures by all QA and laboratory personnel. You will be responsible for organizing contract laboratory audits and certification. You will formulate systems and procedures for the effective implementation of cGMP, GLP (Good Laboratory Practices), and other industry practices and regulations for the manufacture, storage, and distribution of drug products. You will plan and monitor the daily activities of different sections of the department, ensuring the availability of required facilities and materials for daily functions. You will ensure timely review and approval of all Master documents, such as SOPs, guidelines, production records, specifications, validation protocols, and other necessary reports/documents. You will be responsible for proper sampling of in-process and finished products, management of reserve and stability samples, and collection of finished products. You will oversee the execution of in-process controls and checks during manufacturing and packing. Your role includes reviewing and releasing/rejecting finished drug product batches, evaluating product recalls, monitoring quantity and disposition of recalled/returned material. You will participate in investigations, providing suitable Corrective and Preventive Actions (CAPA) to prevent recurrence. You will review, approve, and implement CAPA for incidents, change controls, Out of Specifications (OOS) and Out of Trends (OOT) observations. You will manage vendor qualification, material management, vendor audits, stability management, and field alerts as required. As a qualified trainer, you will implement training programs, ensure compliance, and provide training on cGMP and SOPs. You will ensure compliance with CAPA for deficiencies noted in self-inspections, internal audits, and external audits. Your responsibilities include preparing and approving Annual Product Quality Reviews, reporting Adverse Drug Reactions, and ensuring departmental adherence to safety practices. You will also be responsible for ensuring the safety, strength, purity, and efficacy of the product, along with any other assignments from higher management. Qualifications Educational qualification: An M. Pharm/M.Sc. with experience in Sterile products. Minimum work experience: 15 to 20 years. Skills & Attributes Technical Skills Experience in recruitment and training of QA and laboratory personnel in Chemistry and Microbiology laboratories. Experience in establishing systems and procedures for cGMP, GLP, and other industry practices. Experience in handling investigations, audits, and implementing resulting CAPAs. Skills in vendor qualification, audits, and material management. Behavioural Skills Effective leadership and organizational skills for managing laboratory personnel and operations. Detail-oriented mindset for thorough review and approval processes. Strong communication and collaboration skills for audits, investigations, and compliance activities. Commitment to safety practices and reporting Adverse Drug Reactions. Additional Information About the Department Global Manufacturing Organisation (GMO) Dr. Reddy's Laboratories is dedicated to making an impact on global healthcare through precision manufacturing and innovation. With 19 state-of-the-art manufacturing plants across multiple locations, we are a leading force in the pharmaceutical industry. Our capability to deliver quality medicines to patients in 66 countries is driven by benchmarking manufacturing processes and operational excellence. Benefits Offered At Dr. Reddy's, we prioritize your career growth and professional development through personalized learning programs. Our benefits are designed to meet industry standards, including joining & relocation support, family benefits, learning opportunities, medical coverage, and life coverage. Our Work Culture At Dr. Reddy's, our employees are guided by the principle of "Good Health Can't Wait." We see healthcare solutions as a means to help patients lead healthier lives. Our work culture fosters empathy, dynamism, and teamwork, empowering individuals to make a meaningful impact on global healthcare. Visit our career website at [Dr. Reddy's Careers](https://careers.drreddys.com/#!/) for more details.,

You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Your tasks will include reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. It is essential to critically review documentation intended for submission to regulatory agencies to ensure internal consistency and adherence to relevant guidelines, thereby promoting regulatory excellence. You will be expected to demonstrate expertise in the subject matter and relevant areas, collaborate effectively with internal and external clients, and facilitate clear and efficient communication for operational excellence. A high level of knowledge regarding country regulations and regulatory guidelines, as updated from time to time on various agencies" websites, is also required. To qualify for this position, you must hold a Master's degree in Pharma and possess relevant experience equivalent to 7 to 10 years. Strong technical data interpretation skills, interpersonal skills, oral and written communication skills, and knowledge of US Regulations are essential requirements. Proficiency in using computer applications such as Excel, Outlook, and document management systems is necessary. Additionally, the ability to work effectively in a team-oriented environment, under pressure, and within tight timelines is crucial for this role. As part of the role, you may be required to work in slots catering to different time zones as needed. The position is based in Gurgaon, Haryana, India. Join us and contribute to our global regulatory team as an Assistant Manager in Regulatory Affairs, focusing on the US market and beyond.,