398 Anda Jobs - Page 4

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 quality programs throughout product lifecycle. Amgens CMC submission execution team, R egulatory O ptimization o f T actical and S trategic S upport (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC t...

The Associate III, with minimal to no guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines. The Associate III will be responsible for independently evaluating change controls (intended for post approval changes), will assure the CC is complete and accurate and in the absence of any comments will progress the CC accordingly. In addition, he/she will monitor any/all Regulatory or team databases and trackers and will proactively and accurately update them when changes are required. Annual Reports, supplements, post approval submissions and assisting management with the training of regulatory ...

The Associate III, with minimal to no guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines. The Associate III will be responsible for independently evaluating change controls (intended for post approval changes), will ensure the CC is complete and accurate and in the absence of any comments will progress the CC accordingly. In addition, he/she will monitor any/all Regulatory or team databases and trackers and will proactively and accurately update them when changes are required. Annual Reports, supplements, post approval submissions and assisting management with the training of regulatory ...

Job Summary Payroll Specialist is responsible for executing the organization's payroll activities, ensuring pay is processed on time, accurately and in compliance with government regulations. This role involves payroll, aiding in data gathering, assisting in ad hoc projects and additional payroll works when required. Job Requirements EMEA Based payroll experience is required. Payroll Processing: Work with vendor for preparation and distribution of the company's payroll, ensuring accurate and timely processing of payroll transactions including salaries, benefits, taxes, and other deductions. Compliance: Ensure compliance with as per the government legislation requirements. Stay updated on cha...

Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profile BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

Skills Required: Ensuring contract compliance, mitigating legal risks, and resolving disputes to protect the company's interests Key Responsibilities Administer the Contract Life Cycle Management which includes pre award and Post award Contract Management. Understand and analyze the complete scope of work, in terms of technically and contractually. Review of regular correspondence with Client with respect to all the contractual and on any other site related issues. Ensuring compliance with all contractual & statutory requirements of the project till closure. Formulating claims for variations, price escalation, extension of time, compensation for extended stay, etc. Reviewing key sub-contract...

Role & responsibilities Regulatory Submissions: Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDA Manage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports) Ensure compliance with current USFDA regulations and guidance documents FDA Interactions: Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings) Participate in and support FDA meetings as the regulatory lead Handle Controlled Correspondence with the FDA for product development and regulatory strategy Product Expertise: Provide regulatory support for complex formulations , including injectables and liquid dosage forms Collaborate with R&D, QA, QC, ...

Role & responsibilities Skills Required: Ensuring contract compliance, mitigating legal risks, and resolving disputes to protect the company's interests Key Responsibilities Administer the Contract Life Cycle Management which includes pre award and Post award Contract Management. Understand and analyze the complete scope of work, in terms of technically and contractually. Review of regular correspondence with Client with respect to all the contractual and on any other site related issues. Ensuring compliance with all contractual & statutory requirements of the project till closure. Formulating claims for variations, price escalation, extension of time, compensation for extended stay, etc. Re...

SUMMARY Purpose of Job: Support the effective management of company assets throughout their lifecycle, ensuring accuracy, accountability, and compliance. The role focuses on maintaining updated asset records, monitoring utilization, and assisting in the reconciliation of fixed and movable assets. The position is responsible for providing timely and accurate asset-related data to management; assisting in audits. Job Description: Through Google Sheet operate CAPEX PR & PO. Maintain equipment details. Maintain vendor service PO. It is maintained totally through Google Sheet with a variety of reports. Good knowledge of Excel, Word & PowerPoint. Requirements Required relevant experience (Type and...

We are seeking a highly experienced and driven Global Process Owner to lead the transformation of our Order to Cash (O2C) processes within our finance and accounting function. The successful candidate will be responsible for driving the analysis, design, and implementation of process improvements across multiple business divisions and regions, including the Americas, EMEA, and APAC. This role requires a strong leader who can influence, and impact work delivered from multiple centers across US and Chennai, India, and collaborate with multiple senior stakeholders at the client end. Lead the transformation of the O2C process, focusing on optimizing efficiency, reducing costs, and enhancing cust...

Responsibilities Global Pay Plus Testers. MT MX messaging , SWIFT payments Preferred Skills: Banking->GPP Financial Services Domain->Payments->GPP Generic Skills: Banking Roles and Responsibility Manage and process payments transactions efficiently. Collaborate with cross-functional teams to resolve payment-related issues. Develop and implement new payment systems and processes. Analyze payment trends and provide insights for improvement. Ensure compliance with regulatory requirements and industry standards. Provide excellent customer service and support to clients. Job Requirements Strong knowledge of payment processing and reconciliation. Experience with payment gateways and payment system...

About The Role Project Role : Application Support Engineer Project Role Description : Act as software detectives, provide a dynamic service identifying and solving issues within multiple components of critical business systems. Must have skills : Asset Management Good to have skills : Asset Life Cycle ManagementMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Support Engineer, you will act as software detectives, providing a dynamic service identifying and solving issues within multiple components of critical business systems. Your day will involve troubleshooting, analyzing, and resolving software-related issues ...

Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufact...

Position: RAD-US Market, (CMC, M3) Qualification: M. Pharmacy (Pharmaceutics, Regulatory Affairs) Experience: 6-11 yrs Job Location: Hyderabad Job Type: Permanent Responsibilities: Hands on experience with RA-US market ; responsible for Approved and Tentative Approved ANDAs /NDAs [i.e., filing of supplements (CBE, CBE-30, PAS, Response to Queries, Controlled Correspondence, Annual Reports** /Updates etc.,) 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, an...

Heres how youll contribute: Writing skills, specifically around describing a scene and driving logic Fluent in English language, familiarity with road signs in the US (Other regions including EU is a bonus) AV labeling experience (bounding boxes, etc) College Educated

Support group reporting team in loading data onto HFM from onestream. Clearing validations at HFM / OS Preparation of control sheet OS to HFM walk on monthly basis Assistance during H1 / Annual group audit / FC1 and budget submission Migration of onestream to SAP etc. Requirements: Candidate must be pursuing CA course and eligible for industrial training as per ICAI internship guidelines Good exposure in accounting, taxation, financial analysis, and statutory audits during articleship period Strong understanding of IND-AS, Companies Act, and other relevant accounting standards Advanced proficiency in MS Excel (including financial modeling, pivot tables, VLOOKUP)

Your Role Take overall responsibility and project manage the implementation of travel products for clients. Document and track projects using client-specific processes and tools. Act as the single point of contact for the project team throughout the implementation process. Ensure adherence to the client-defined onboarding process, from pre-assessment to post-implementation. Lead local Joint Planning meetings and ensure effective collaboration. Clarify and communicate roles and responsibilities to all project members. Lead weekly conference calls, prepare agendas, and produce detailed call notes. Monitor project progress, ensure timely completion of tasks, and update project tracking tools (e...

We required candidate for the position of AGM-Formulation Exp in OSD-Immediate Release (IR),Extended Release (ER),Powder for Suspension(PFOS) &Oral Liquid dosage forms for US,EU&Canada. T-Exp-15 + CTC-Upto 30.00Lacs Loc-Mumbai(Kandivali)

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge o...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, co...

As a Regulatory Affairs Manager, you will play a crucial role in monitoring the company's production activities to ensure compliance with all applicable regulations and standard operating procedures. Your responsibilities will include devising regulation compliance strategies, creating training and orientation programs for staff, conducting internal inspections and information drives, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of Chemistry, Manufacturing, and Controls (CMC) aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents ac...

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP EWM Good to have skills : NA Minimum 5 year of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving act...

Recorders and Medicare Systems Pvt Ltd is looking for RA Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available ...

SUMMARY Purpose of Job: Support the effective management of company assets throughout their lifecycle, ensuring accuracy, accountability, and compliance. The role focuses on maintaining updated asset records, monitoring utilization, and assisting in the reconciliation of fixed and movable assets. The position is responsible for providing timely and accurate asset-related data to management; assisting in audits. Job Description: Through Google Sheet operate CAPEX PR & PO. Maintain equipment details. Maintain vendor service PO. It is maintained totally through Google Sheet with a variety of reports. Good knowledge of Excel, Word & PowerPoint. Requirements Required relevant experience (Type and...

Job Title: Executive FRD Non Orals Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own SunshineAs you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Job Description To design and conduct experiments for preformulation, for...