3208 Regulatory Affairs Jobs - Page 32

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...

Medcare Hospitals Medical Centres is looking for Specialist - ENT to join our dynamic team and embark on a rewarding career journey. The Specialist - ENT, also known as an Otolaryngologist or Ear, Nose, and Throat Doctor, is a medical professional specializing in the diagnosis, treatment, and management of diseases and disorders affecting the ear, nose, throat, head, and neck regions. They provide specialized medical care to patients with various ENT conditions, offering both non-surgical and surgical interventions as required. Key Responsibilities : Patient Consultation and Examination : Conduct thorough patient assessments to gather medical history, symptoms, and perform physical examinati...

Job Description : Key Responsibilities: Literature search to prepare, review, and finalization of any clinical/non-clinical document Review of feasibility and related request for proposal (RFP) study synopsis Review of clinical documents, not limited to protocol, informed consent documents, subject diary, clinical study report and similar other documents etc Preparation and review of medical monitoring plan Therapeutic training of all stakeholders and if applicable to the site team via in-person / virtual for safety reporting in clinical trials along with medical monitoring plan and safety monitoring plan Participation presentation in Subject Experts Committee (SEC) meeting, PI meet Site Ini...

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: Knowledgeable in all disciplines of ecotoxicology, including aquatic, plants, avian, mammals, and terrestrial. Conduct ecotoxicological risk assessments and provide expert guidance to internal colleagues on ecotoxicology issues, including responses to Regulatory decisions, Data Call In reviews and recommendations, and planning defense strategies around ecotoxicology concerns. Experience with interacting with regional Regulatory Agencies especially US-EPA and European Authorities. Familiar with global data requirements, including North America, Brazil, LATAM, and Europe. Contract ecotoxicology studies at external labs. Interpret study results and implications of results. Provide ...

Preparation of registration strategy for Brazil submission Adequate understanding on respective authority guidance and filing of new product and post approval changes Review of documents related to product registration and dossier submission leading to faster approval Prepare response to deficiency letter received from Anvisa, Brazil Maintain life-cycle (PCH) / post approval changes for drug product registration dossiers including timely circulation of approval information Provide regulatory support to cross functional department Adequate assessment of change control as per regulatory guidance Prepare and submit scientific advice to Anvisa, Brazil

Role Overview: Tradeweb is looking for a trade surveillance officer, based in Bengaluru, to provide trade surveillance coverage across Tradewebs European trading venues. The European trade surveillance team monitors and analyses the trading activity of all participants across the Tradeweb European platform. Surveillance utilises and develops electronic tools and integrative techniques to detect potential and/or actual violations of regulatory requirements, and works in close partnership with the wider Compliance team, Technology, Business Managers and various groups across the firm to ensure that Tradewebs markets remain clean and orderly. To succeed in this role, you will need to be a team-...

Before you apply to a job, select your language preference from the options available at the top right of this page. Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrowpeople with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level. About The Role : Job Summary The Healthcare Quality Assurance (QA) System Validation Supervisor provides guidance to UPS Supply Chain So...

Key Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries . • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission • Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations. • Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation . • Ensure submission t...

Responsibilities: Analyze and document complex healthcare business requirements, translating them into actionable technical specifications and user stories Collaborate with cross-functional teams including product managers, developers, QA, and clinical stakeholders Drive interoperability initiatives across platforms, ensuring seamless data exchange and integration Support compliance efforts by aligning deliverables with ISO 13485, IEC 62304, and other relevant standards Participate in solution design discussions, contributing domain expertise and analytical insights Maintain traceability of requirements and ensure alignment with quality management system (QMS) documentation Qualifications: B...

Responsibilities: * Collaborate with cross-functional teams for documents and dossier compilation * Ensure compliance with regulatory guidelines & standards * Documentation. calibration, validation,....

Key Responsibilities: 1. Regulatory Submissions & Strategy (EU Markets : Lead regulatory submissions and manage post-submission activities for EU markets. Ensure all filings and responses are compliant with applicable regulations. 2. Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure timely and accurate preparation of regulatory submissions, including Clinical, Quality, and Nonclinical documents. 3. Regulatory Document Review: Lead the review and compilation of all relevant regulatory documents in line with local and international guidelines. Ensure technical arguments are clear and conclusions are adequately supported by data. 4. Label...

We are looking for a highly experienced and skilled finance professional to lead our financial team as a Director-Finance at Marriott International. The ideal candidate will have a strong background in finance and accounting, with excellent leadership and management skills. Roles and Responsibility Oversee the development and implementation of financial strategies to drive business growth. Manage and analyze financial data to inform business decisions and optimize performance. Lead and manage a team of finance professionals, providing guidance and support. Develop and maintain relationships with external stakeholders, including auditors and bankers. Ensure compliance with financial regulatio...

Job Description To lead, establish, maintain, and continually improve the Quality Management System (QMS) in accordance with ISO 13485:2016 and EUMDR. Preparation and maintenance of Technical Files of Medical Equipment as per MDR 2017/745, ISO 14971, ISO 10993-1. To plan, establish, document, implement, maintain, and update a post-market surveillance. He shall ensure that the post-market surveillance obligations comply with Article 10(10) of the EU Regulation 2017/745 & other applicable standards. Design & development documentation.

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...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. **Role Overview:** - Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post-ma...

Roles & Responsibilities: Preparation and timely update of Technical Files Regular updating of the Quality Manual Review and update of all relevant Standard Operating Procedures (SOPs) Review and revision of Work Instructions as per process requirements Preparation of Marketing Support Documents from QA perspective Review and update of internal Formats and Templates Periodic review and update of Site Master Files Must have working knowledge of various audits related to the medical device industry , including ISO 13485 , MDSAP, and CDSCO inspections

Manage daily operations of regulatory function of the assigned category Liaise with a range of colleagues from Marketing, R&D, supply, and global/regional regulatory teams. Maintain Regulatory Databases Review, interpret and assess impact of the regulatory changes. To manage compliance activities for Sustainability under Plastic waste management, Battery waste management and E-waste management rules across Reckitt entities & portfolio Preparation, maintenance and update of product registration/license and regulatory compliance files. Compilation of registration dossiers for submissions to authorities Coordination with central and state regulatory authorities/ FDAs for necessary product appro...

Boston Scientific is seeking an experienced Principal Cybersecurity Engineer with a strong background in the design, development, and testing of cybersecurity features and controls in a regulated industry. As a Principal Cybersecurity Engineer, you will play a crucial role in overseeing and guiding the cybersecurity strategy throughout the product lifecycle within the R&D Division. **Key Responsibilities:** - Lead the design, implementation, and maintenance of comprehensive security measures across all stages of medical device development, ensuring compliance with relevant regulations and standards while safeguarding patient data and device integrity. - Design and implement secure architectu...

Role & responsibilities Desired candidate profile 1) Computer Knowledge MS-Office - Excel 2) Good Communication verbal & written 3) Understanding of corporate & commercial laws 4) Contract management, legal advisory or regulatory affairs Brief Job Profile and Description 1) Draft, review, and negotiate commercial agreements 2) Ensure contracts comply with internal policies and legal guidelines 3) Provide legal opinion and support 4) Maintain legal records, trackers, and MIS reports. Preferred Industry Experience 2-3 years in corporate legal roles Educational Qualification Bachelor’s degree in Law (LLB) Preferred candidate profile 2-3 years in corporate legal roles

Role & responsibilities 1. Product Registration & Certification - Support in preparing the documentation or dossier as applicable for the product registration and the certifications. - Update the documents, for response to queries and other requirements as required by respective regulatory authorities in a stipulated time frame. 2. Regulatory Audits -Internal and External Audit - Provide assistance in Internal & External audits. - Draft, Internal audit reports and coordinate with auditors for the closure of audits in a timely manner - Assist with follow-up audits, as required. 3. QMS-Maintenance - Compile and maintain regulatory documentation databases as per ISO 13485:2016 and other applica...

Greetings of the day ! Our reputed MNC Client is hiring for: Designation: Regulatory Affairs- EU Market- Pre & Post Approval Location: Hyderabad Shift: General Work Mode: WFO (5 days working) Interview Mode: F2F interview NOTE: Looking for candidates from Generic Pharma and not from API as this is for formulation Role & responsibilities: 1. Component with EU-Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module 2. Well versed with EU- Regulatory guidance and Processes (i.e. Ability to understand and interpret technical expectations as per applicable ICH & EMEA guidelines) 3. Clear Knowledge of basic aspect...

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.

Role & responsibilities Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers. Coordinate with factory.Role & responsibilities Preferred candidate profile 1-3 Years Experience In Regulatory Affairs for formulations. Excellent communication skills both written and verbal.

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...