2122 Regulatory Affairs Jobs - Page 15

Client Interaction: o Develop and maintain strong relationships with clients, understanding their taxation needs and providing tailored solutions. o Act as the primary point of contact for clients on tax-related queries and concerns. Direct Taxation Advisory & Compliance: o Provide advisory on direct tax matters such as income tax, corporate tax, GST, and international taxation. o Handle tax compliance work, including preparation and filing of income tax returns, TDS, and other related documents for clients. o Assist in structuring transactions from a tax efficiency standpoint and advise on the tax implications of business strategies. Tax Litigation Support: o Represent clients in tax assess...

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top manag...

Administrative support Performs general coordination and administrative tasks to support the Regulatory Translation Hub functioning. Grants access to relevant CO associates to hub repository folders and keeps access information updated. Organizes and archives documentation in team repositories, including dispatch emails and surveys as required. Ensures renewal of licenses regarding translation-related software and indexing tools, including Trados Studio, Verifika, and dtSearch Updates team lists and trackers, e.g. general job list, invoicing tracker, QC tracker, quality incidents tracker, email contact lists, CO job list tracker. Assists team members with the preparation of reports and prese...

Key Responsibilities 1. Leadership & Team Management Manage and developa team of labeling specialists, providing direction, mentorship, and performance feedback to encourage professional growth. Foster a collaborative environmentby guiding cross-functional teams to meet global labeling objectives and deliverables. Set clear goals and priorities for the labeling team, ensuring alignment with broader Regulatory Affairs and organizational strategies. 2. Labeling Planning & Execution Oversee end-to-end labeling projects,from content creation and revisions to final implementation, ensuring on-time, in-full delivery. Coordinate across functions(e.g., Regulatory Affairs, Quality, Operations, Supply...

As a Product Stewardship & Regulatory Specialist at Axalta, you will play a crucial role in ensuring regulatory compliance and supporting customer service and operational activities. Your responsibilities will include processing raw material regulatory data, preparing various reports, and managing raw material vendor SDS changes. Additionally, you will be expected to maintain accurate records and follow established procedures and work instructions. In terms of customer and operations support, you will be tasked with fulfilling PSRC customer requests in a timely manner, such as providing Safety Data Sheets (SDS), Environmental data sheets (EDS), IMDS/CAMDS sheets, and other relevant documents...

The main purpose of the role of Team Member CDT Regulatory Affairs - AP I at CIPLA R & D is to compile dossiers in accordance with regulatory strategy, manage deficiencies, evaluate products, and submit tenders to ensure adherence to regulatory requirements for various regulated/international markets within agreed timelines. As a Team Member CDT Regulatory Affairs - AP I, your responsibilities will include reviewing documents, compiling and submitting quality dossiers in line with regulatory guidelines for various regulated/international markets to minimize deficiencies from health authorities. You will also be required to evaluate and compile quality deficiency responses for all regions to ...

Responsibilities: * Manage regulatory compliance programs * Ensure accurate documentation & reporting * Handle audits & inspections with confidence * Develop policies & analyze regulations * Oversee compliance handling & management Work from home Over time allowance Provident fund

To review, compile (Module 1 to Module 5) and submission of ANDA’s for dosage forms (Tablet and Capsule).USFDA guidelines, meet GDUFA timelines, review DMF and its updates.

Job Title Regulatory Affairs Intern Job Description Your role: 1. Tracking and establishing Process of PC& PNDT (Pre Conception & Pre Natal Diagnostic Techniques) regulations at the District / State level for the sale / supply / demonstration of medical devices that come under PC& PNDT regulations. 2. Tracking and establishing Process of AERB (Atomic Energy Regulatory Board) regulations at the District / State level for the sale / supply / demonstration of medical devices that come under PC& PNDT regulations. 3. Consolidating, Reviewing and Establishing activities under Regulatory Affairs function of Philips India Ltd (HS). Youre the right fit if: 1. You are pursuing a degree in Life Science...

International Solar Alliance is looking for REGULATORY SPECIALIST to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assistant...

MAIN PURPOSE OF ROLE Summarize the main purpose of the role. Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions. MAIN RESPONSIBILITIES As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interacts with regulatory agency to expedite approval of pending r...

Key Responsibilities: Liaising with doctors, nurses, and other healthcare professionals to ensure the safe, effective, and economical delivery of drug treatments. Participating in dispensary work, including clinical checks and accuracy checking of prescriptions and dispensed medicines. Ensuring all work complies with Medicines Ethics and Practice, local policies and procedures, risk management, and health and safety protocols. Dispensing and supplying medicines. Receiving, storing, and supplying controlled drugs in accordance with hospital policy. Creating purchase orders (P.O.) and preparing GRNs for the same. Processing purchase returns of medicines due to expiry. Handling narcotics and ma...

About The Role Credit Card Process Manager Marketing HO Department Credit Card Products Location Infiniti IT park Reporting Relationship Position Grade Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital / Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identificatio...

We are seeking a talented individual to join our Insurance Operations team at Marsh. This role will be based in Mumbai. This is a hybrid role that has a requirement of working at least three days a week in the office. Senior Manager Insurance Operations (Grade E) Were seeking a Senior Manager Insurance Operations who is prepared to manage a team responsible for complex and varied insurance tasks. This role is critical in fostering a culture of excellence, ensuring operational efficiency, and driving the performance of multiple teams. The ideal candidate will possess a strong background in the insurance sector or related industries, with a proven ability to manage diverse teams working with t...

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The company is organized into two key segments: Specialty Pharmaceuticals and Generics & APIs. In the Specialty Pharmaceuticals segment, Jubilant Pharma focuses on Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. The company also specializes in Generics & APIs, which includes Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) serves as a wholly-owned subsidiary of Jubilant Pharma, with Research & Development units located in Noida and Mysore, India. JGL ...

The Associate, Regulatory Affairs is responsible for supporting regulatory efforts related to the submission of supplemental ANDAs, ANDA Annual Reports, Drug Listing, SPL/PLR (labeling), and other regulatory compliance matters to assist the company's approved product portfolio, both internally and externally. Key responsibilities include: - Compiling and submitting Post Approval Supplements such as PAS, CBE-0, CBE-30. - Preparing, reviewing, and submitting amendments and supplements for assigned products. - Preparing, reviewing, and submitting responses to the Agency's queries for assigned products. - Compiling and submitting Global Annual Reports. - Reviewing stability protocols and reports...

The Quality Control Analyst at Vasta Bio-Informatics Private Limited in Navi Mumbai-I, Maharashtra, will be responsible for various duties and responsibilities as outlined below: Quality Management: - Conduct audits on assigned cases under the guidance of the Project Manager. - Provide timely feedback to abstractors post-audit (within 24 hours). - Develop corrective action plans for cases with recurring errors and ensure timely corrections. - Maintain detailed records of time spent on audits, completed audits, and any other reporting tasks assigned by Operations and QA management. Training and Monitoring: - Identify and escalate performance concerns and issues as necessary. - Assist in the r...

The person will be responsible for project specific regulatory consulting services at the firm. You will have complete ownership of all regulatory projects, including dossier writing, submissions, approval tracking, and query resolution across Developed and Emerging markets. Your role will involve ensuring regulatory compliance, accuracy, timely completion, version control, and adherence to internal SOPs. Additionally, you will provide strategic input to the Management and Partners on regulatory projects. It is essential to keep abreast of new developments in regulations across all critical health authorities. The ideal candidate should have formal regulatory affairs experience for a minimum...

The Sales Manager role based in Chennai, India (with PAN India coverage) requires an experienced professional with 8-10 years of experience in food ingredient B2B sales. The ideal candidate will hold a Bachelor's Degree, preferably in Food Science or a related field. With approximately 50% travel requirement for client meetings, key accounts, and distributors, you will be responsible for driving revenue, volume, and gross margin growth for the food ingredients portfolio across India. As a Sales Manager, your primary objective will be to own and achieve sales, volume, and profitability targets nationwide. You will need to develop and execute strategic sales & marketing plans for key accounts ...

Job Description: As a Regulatory Affairs Manager at McW Healthcare, you will play a crucial role in ensuring regulatory compliance and maintaining quality systems in our pharmaceutical company based in Indore. Your responsibilities will include handling regulatory requirements, submissions, and overseeing day-to-day operations related to regulatory affairs. To excel in this role, you should possess strong skills in regulatory compliance, regulatory requirements, and regulatory submissions. A deep understanding of quality systems is essential to maintain the high standards of our WHO approved facility. Attention to detail and analytical abilities will be key as you navigate the complexities o...

You should have an M Pharm / B Pharm / M Sc degree with a minimum of 1 year or more of experience in the Regulatory Affairs function within a Medium / Large Scale Pharmaceutical organization. Your experience should include a good understanding of domestic licensing procedure, loan licensing, as well as licensing and approvals in regulated countries and ROW Markets. Your role will require a strong orientation towards regulatory requirements in India and overseas countries. This includes handling country-specific documentation, coordinating with various departments internally, following up and coordinating with regulatory authorities, understanding regulatory norms, and continuously updating y...

As a valued member of our team, you will have the opportunity to play a pivotal role in shaping the future of healthcare by managing technical service operations in India and the subcontinent. Your innovative thinking and proactive approach will drive positive change, creating new opportunities to enhance outcomes and make a difference. Your primary responsibilities will include collaborating with service, operational, and commercial leadership to develop and expand the local service product portfolio. You will work closely with internal and external stakeholders to manage technical service operations effectively and ensure optimal customer satisfaction. Additionally, you will be responsible...

Genpact (NYSE: G) is a global professional services and solutions firm dedicated to shaping the future through the delivery of outcomes. With a workforce of over 125,000 employees spanning across 30+ countries, we are fueled by curiosity, entrepreneurial agility, and a commitment to creating lasting value for our clients. Our purpose, driven by the relentless pursuit of a world that works better for people, enables us to serve and transform leading enterprises, including the Fortune Global 500, leveraging our profound business and industry expertise, digital operations services, and proficiency in data, technology, and AI. We are currently seeking applications for the position of Manager- La...

You will be responsible for handling regulatory affairs in XEVMPD (Extended Eudravigilance Medicinal Products Dictionary) and RIMS. The ideal candidate should have a minimum of 2-5 years of relevant experience in this field. Additionally, experience in veeva-vault for creating RO/SO events, XEVMPD submission, and knowledge of IDMP and QMS database will be beneficial for this role. The position is based in Mumbai.,

Responsibilities: * Oversee regulatory affairs processes * Manage dossier submissions & preparations * Ensure compliance with the Latam market requirements * Lead row market strategies * Client query resolution. * Artwork review.