2122 Regulatory Affairs Jobs - Page 14

About The Role Candidates key responsibilities would include supporting the London Tax team in the following areas quarterly tax provisions and forecasting process for EMEA House entities including the reporting of cash tax payments and the preparation of uncertain tax positions (FIN 48) calculations. annual corporate tax compliance for EMEA House entities, including performing a first level review of the local tax advisors work papers and draft tax returns and partnering with them to ensure the timely submission of all tax filings and settlement of local tax liabilities. preparation and collation of tax data for EMEA House entities in respect of the annual tax reporting requirements for the...

A Day in the Life Responsibilities may include the following and other duties may be assigned. Clinical Collects, maintains, archives, and retrieves necessary source documents to ensure compliance with applicable SOPs and complete Scientific communication deliverables Supports leadership in compiling necessary documents and other tasks during audits Supports submission related activities which may include but not limited to CAP Agile upload and Veeva review/upload Assist in the development and execution of meetings between internal and external cross-functional partners Develops mechanisms for monitoring project progress and for intervention and problem-solving with leadership. Assists in tr...

Career Category Information Systems Job Description The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. .

Roles and Responsibilities Manage registrar activities, ensuring compliance with academic administration policies and procedures. Oversee recognition processes for new programs, courses, and qualifications. Develop and implement policies related to regulatory affairs, accreditation, data management, and quality assurance. Provide guidance on policy making and implementation to ensure effective governance of educational institutions. Collaborate with stakeholders to resolve issues related to policy violations or non-compliance. Desired Candidate Profile 5-10 years of experience in a similar role within an educational institution or industry setting. Strong understanding of academic administra...

We are looking for a skilled Senior Executive to lead our transport operations team in ACME SERVICES PRIVATE LIMITED. The ideal candidate will have 4 to 8 years of experience in the employment firm or recruitment services industry. Roles and Responsibility Manage and oversee daily transport operations for smooth and efficient service delivery. Coordinate with drivers, mechanics, and other stakeholders to ensure timely issue resolution. Develop and implement strategies to enhance operational efficiency and reduce costs. Monitor and analyze performance metrics to identify areas for improvement. Collaborate with the logistics team to optimize routes and schedules. Ensure compliance with regulat...

As a Regulatory Affairs Manager at Vibcare Healthcare, a leading pharmaceutical manufacturer committed to enhancing health outcomes through innovative and quality assured pharmaceutical products, your primary responsibility will be ensuring regulatory compliance, managing regulatory requirements, overseeing regulatory submissions, and maintaining the quality system. You will play a crucial role in upholding unparalleled transparency and quality in all our offerings, certified by WHO-GMP standards. To excel in this role, you should possess expertise in regulatory compliance, regulatory requirements, regulatory affairs, regulatory submissions, and quality system management. Your strong attenti...

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 Regulat...

Job Title: Legal Intern Company Secretary Location: Thane Department: Legal & Secretarial Internship Duration: 6 months Reporting To: Company Secretary Legal & Compliance Stipend: As per the industry norms Key Responsibilities: Assist the Company Secretary in mapping statutory and regulatory compliance requirements applicable to the company and its subsidiaries. Support data collation and documentation for feeding into the compliance management system. Work with internal stakeholders (Legal, Finance, HR, Operations) to gather and validate compliance-related data. Help review and verify checklists, registers, and filing records for integration into the software platform. Track progress and as...

Dear Candidate, Greetings from RightHire!! Weve been retained by a leading multi-billion-dollar company into Oil & Gas to fulfil its manpower requirement. And currently, were scouting for State Team Lead – Statutory to be based out at Baroda, Varanasi & Lucknow. Please find below a brief JDs & revert me back with your updated CV should the role suits & excites you to join in such a prestigious company. Note: Ideal candidate must have extensive experience & exposure in statutory compliances / regulatory affairs only from oil & gas/EPC/energy sectors having similar experience. The selected candidates shall be assigned the respective state to lead all the compliances for opening new petrol pump...

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...

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 Trusted Emerging 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 managem...

Role & responsibilities Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, and regulatory standards in response. Evaluation and good interpretation of post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines. Evaluate and interpret post-approval changes & Review of Pharmaceutical Development Reports, Review key regul...

Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents according to EU regulatory requirements. To identify and classify the changes as per EU regulatory variation guidance. To prepare response to regulatory deficiencies letters according to EU regulatory requirements To collaborate with other departments/partners To maintain lists/documents/records Responsible for keeping Orion internal regulatory system up to date and accurate To achieve his/her responsibilities within the agreed timescales To actively participate in the development of regulatory ski...

Career Category Regulatory Job Description Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and...

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...

Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands company€™s customer base and ensure it€™ s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Analyses, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies Responsible for identifying duplicate/invalid ICSRs Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports Perform data entry for all subject information into EDC databases as required Perform peer review, quality review of cases...

Review of the world wide scientific and medical literature in accordance with companies-controlled documents. Maintain organized records of all literature safety reports received and reported. Basic entry of MLM cases received from the authority by uploading and importing XML and RTF files and by analysing received source document. Perform duplicate check. Manage tracking of MLM cases with source of receipt. Ensuring compliance with local regulations and companys global pharmacovigilance requirement. Weekly reconciliation of MLM cases with source of receipt. Deliver training to new joined and team as per requirement. Case processing including data entry, drug coding, MedDRA coding, assessmen...

Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for submission to local and other Health Authorities. Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities. Authoring of Signal Management Reports. Performing literature search and validity check for the aggregate reports. Reconciliation of relevant process trackers. Extraction and validation of data (RSI, Sales, previous reports, RMP, signals). Generation of Line Listings (LL) from safety database Providing reliable support for high priority Ad-hoc activities. Ensure all the reports are drafted within the allocated timelines.

: Execute audit strategy and plan of concurrent audits testing in accordancewith the Policies, Procedures, Legal, Statutory and Regulatory requirements, Internal Audit Standards, and leading best practices. Maintain and update concurrent audit procedures and checklists to ensure they remain current and updated keeping pace and aligned with changes in internal policies/guidelines as well as legal/statutory/regulatory changes and evolving industry best practices. Ensure timely and quality execution of concurrent audit reviews . Ensure timely completion of Concurrent audit plan with quality of audits, and meet with all concurrent audit documentation and reporting requirements as per Concurrent ...

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for USFDA regulatory submissions. Coordinate with third-party agencies for audits and inspections (USFDA, WHO). Ensure compliance with GMP requirements through self-inspection and third-party audits. Maintain liaison with government authorities for licensing and approvals. Provide guidance on legal metrology regulations to ensure accurate product labeling. Desired Candidate Profile 7-12 years of experience in Regulatory Affairs or related field (nutraceutical industry). Bachelor's degree in Pharmacy (B.Pharma) from a recognized institution. Strong knowledge of FSMS, Food Safety, HACCP, FSSAI, Legal Metrology, a...

Job Responsibilities- Assisting in developing audit planning documentation addressing scope,auditobjective, budgeted hours, resource plan,and reporting date Complete assignedaudits, addressing allauditobjectives, conducting clientandstatus meetings as required, controlling, monitoring,and reporting onauditprogress, reviewing work papers,and ensuring work papers provide adequate support of conclusions while complying with internal standards for documentation. To monitor the assignment for improving the efficiency of the assignment, manageauditin relation to time and resource budget Will actively check that all findingsandissues are documentedandperform closedown procedures Gatheringandcompili...

Job responsibilities: Having experience in concurrent Audit Conducted Comprehensive audit for banks To ensure accuracy, authenticity, and compliance with the procedure and guidelinesof banks are followed. Working on regulatory returns of bank Should be presentable and have good communication skills

Collect and review documents to ensure FGI has the appropriate documents required. Complete work permit and other immigration forms. Assist in the preparation of letters for case work. Collate cases for submission. Prepare submissions for client signature and upload to IRCC portal for adjudication. Update case management system throughout entire case lifecycle (milestones, emails, approvals, etc.). Communicate with client through balance of process for updates. Review and update client reports on a daily/weekly basis. Generate weekly client status and audit reports via case management system.

Project Manager- Business Consulting Risk - FSRM Our FSRM team is a fast-moving, high-growth area with huge potential. It offers variety, challenge, responsibility, and the opportunity to realize your leadership potential. Our Financial Services Risk Management (FSRM) practice focuses on risk management, regulatory, quantitative, and technology backgrounds. The breadth of experiences of FSRM professionals enables the practice to coordinate the delivery of a broad array of risk management services to capital market participants throughout the world in a well- integrated manner.