413 Ra Jobs - Page 10

Dear Doctor's, We have excellent opportunities for freshers & experienced of "Anaesthesiologist" in Various Super & Multi Specialty Hospital and Diagnostic Center of Various with good Package & Accommodation + Incentive. Job: Title: Anaesthesiologist Qualifications: MBBS- MD/DA/DNB Package: Upto - 30 to 45 LPA Location: Chhattisgarh - Surajpur, Mungeli. Madhya Pradesh - Mandsaur Maharashtra - Nanded Rajasthan - Dudu Position Type : Full Time Skills: Anesthesiologist, OT, Critical Care, Emergency, Casualty, Intensive Care, Operation Theater, GA, RA, MAC, breathing management (mask ventilation, intubation, LMA), pain management, hypotension, anaphylaxis. Preferred Skills: Experience with a var...

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines receive...

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

About the Role: Grade Level (for internal use): 10 About the Role: EMEA Benefits Specialist The Team: The Global Benefits Team is a team of specialists that focuses on the Wellbeing and Benefits for our colleagues across the globe supporting 40+ countries. The Impact We invest in our success as a company by investing in our people. At S&P Global, we are committed to comprehensive, competitive benefits for our people. We provide benefits to support the health and financial needs of our people while helping make their working life experience more rewarding. This is a critical role that touches each of our colleagues and is critical to our People First Philosophy. This role supports the wellbei...

We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .

How to Apply: Interested candidates are encouraged to send their updated CV via email or get in touch with us directly: Email: aratib@itm.edu Contact: Arati 88794 19086 Location: Kharghar, Navi Mumbai Organization: ITM Group of Institutions (www.itm.edu) Are you passionate about academic research and higher education? ITM Group of Institutions is inviting applications for the position of Research Associate to join our vibrant academic team in Kharghar, Navi Mumbai. Benefits: 3 Paid Leaves Every Month Provident Fund (PF) Mediclaim Coverage Gratuity Benefits Job Role: Coordination with students for resolving their queries. Managing certification programs coordination Arranging guest faculties ...

Company: Leeford Healthcare Ltd. https://www.leeford.in/ Position: Asst. Manager / Manager - Drug Regulatory Affairs (Domestic Market) Job location: Ludhiana Experience : 6 yrs above Job Profile: Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations. Handling and responding to all the product specific queries. Performing Root cause and analysis and preparing replies to the show cause notices Ensuring overall compliance with domestic regulatory requirements. Co-ordination with respective departments. Maintaining familiarity with company product ranges. Keeping up to date with changes in regulatory legislation and guidelines. Ensuring that quali...

Company: Leeford Healthcare Ltd. https://www.leeford.in/ Position: Asst. Manager / Manager - Drug Regulatory Affairs (Domestic Market) Job location: Ludhiana Experience : 6 yrs above Job Profile: Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations. Handling and responding to all the product specific queries. Performing Root cause and analysis and preparing replies to the show cause notices Ensuring overall compliance with domestic regulatory requirements. Co-ordination with respective departments. Maintaining familiarity with company product ranges. Keeping up to date with changes in regulatory legislation and guidelines. Ensuring that quali...

Company: Leeford Healthcare Ltd. https://www.leeford.in/ Position: Asst. Manager / Manager - Drug Regulatory Affairs (Domestic Market) Job location: Ludhiana Experience : 6 yrs above Job Profile: Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations. Handling and responding to all the product specific queries. Performing Root cause and analysis and preparing replies to the show cause notices Ensuring overall compliance with domestic regulatory requirements. Co-ordination with respective departments. Maintaining familiarity with company product ranges. Keeping up to date with changes in regulatory legislation and guidelines. Ensuring that quali...

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 : Document Management Systems (DMS) Good to have skills : NAMinimum 5 year(s) 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 project milestones are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also ...

Role & responsibilities 1.Ensure proper documentation and fulfillment of statutory requirements with regards to various FDA authorities. 2. Collect information from various departments and prepare DMFs, Dossiers, amendments and supplements etc 3. Submit them to the pertinent regulatory authorities within a specified time frame to get approval. 4. Respond to queries as they arise and ensue that regishation/approvals are $anted without delay. 5. Coordinate customer and reeulatorv audits. 6. Provide compliance to customer complaints by coordination with marketing department. 7. Keep up to date of national and intemational legislations, guidelines (available on websites) and customer practices a...

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Get feedback from all the countries for respective variation, and their timely submission. 7. renewals. 8. Master data Updating. 9. Follow ups with plant for documentation regularly and review meeting. Preferred candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products Must hav...

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 10 years of experience in Formulations OSD 2. Willing to work in Chennai 3.Strong expertise in European, EMA, MHRA & other international regulatory framework 4.Knowledge of ICH & regulatory

Preparation of RA Bills and getting it certified with concern Project Management Consultants & Cost Consultants Team. Responsible for study of BOQ (Bill of Quantity) as per specifications and taking out quantities from drawings Identification and preparation of extra items and coordination with procurement department To coordinate with account team for invoice preparation and bank guarantee Billing, Measurement & Reconciliation Reconciliation of material & bill checking as per the joint service measurement To verify the quantities of materials purchased as per Drawing. Reconciliation of materials as per bill & site inward challans. Preparation of Handing over Documents & Billing documents. P...

Original Application submission Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve outs based on patents and exclusivity claims Labeling Query responses/ REMS and Patent Amendments/ PNP Requests Thorough review/interpretation of FDA comments. Review of revised labeling and response. Tracking/ Review for Completeness/ Timely Submission of REMS correspondence/ Amendments Review of patent amendment & proprietary name review request Submission of Final Approval Requested Life Cycle Management Track RLD labeling changes Initiate labeling revision activity as per RLD label revision/safety labeling change SLC notification fr...

Rama Super Speciality Hospital is looking for ENT Surgeon to join our dynamic team and embark on a rewarding career journeyExamining patients to diagnose and evaluate their medical conditions, including the use of diagnostic equipment and tests such as X-rays and MRI scans.Developing and implementing treatment plans, including the use of surgical procedures and other medical therapies.Performing surgical procedures to treat conditions such as ear infections, hearing loss, sinusitis, voice and speech disorders, sleep apnea, and head and neck tumors.Communicating with patients and their families, discussing diagnoses and treatments, and answering questions and concerns.Collaborating with other...

Job Summary: We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing pharmaceutical products across ROW & regulated markets. Key Responsibilities Regulatory Strategy & Compliance: • Coordinate with agents, partners, and MOHs to define submission strategies. • Prepare internal strategy documents and lead regulatory discussions for new products. Dossier Management & Submissions: • Manage CTD/ACTD/eCTD submissions for ne...

To ensure that products with all regulations and legislation, both National and international,throughout the product lifecycleThe RAP works closely with R&D manufacturing QA/QC and mkt to ensure timely registration,compliance and approval of products

Do you want to contribute to the future of healthcareAs Siemens Healthineers values those who dedicate their energy and passion to this cause, our company’s name is dedicated to our employees. It’s their pioneering spirit, blended with our long history of engineering in the ever-evolving healthcare industry that truly makes us unique as an employer. We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone to grow both personally and professionally. Sound interesting Then come in and join India team as Regulatory Affairs Specialist. Your tasks and responsibilities: Planning and preparing product related medical device submissions for the products manuf...

Industry: Payments/ Financial Services business Functional Area: Payments and Financial Services Role: Senior Manager Reporting to :Director Legal Key Skills: Drafting, vetting, and negotiating agreements, Providing legaladvice, Product counselling, Interpreting regulations and providing guidance to internal teams, Risk identification and Management. Experience: Minimum 10+years experience, including experience inPayments/ FinancialServices/ FinTech (required). Education University Degree in law. A Masters Degree in Law is not mandatory, but will be an added advantage. Location: Bangalore PRIMARY RESPONSIBILITIES : Business Reviewing existing products, as well as new products/ features, with...

To maintain and control overall QMS documentation. To monitor the compliance of standard operating procedure of all departments. Responsible to handling of FDA and certification works in absence of

Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA

Role & responsibilities Custodian of the packaging design and layout for all products Provides relevant source data for the Change Order/ Change Awareness notification Annotate the PDFs as per the respective Regulatory source content (word format) Clarify on need basis with the respective stakeholders, i.e. Labelling Lead, Artwork Coordinator, Market or Site Adherence to GSK artwork production standards and Standard Operating Procedures Identifies and engages other individuals who need to be involved in the review and approval of a Change Order, in accordance with any local procedures and requirements Participates in the review of the change on its viability on behalf of the market For chang...

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products Collaboration with partners to develop and execute global regulatory activities DMF preparations, review of changes and routine updates to Global Regulatory Agencies Dossier preparation...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Science...