3208 Regulatory Affairs Jobs - Page 13

Job Title : Product Owner (Business Analyst) Location : Bangalore (Hybrid 2 days in office) Experience Required : Total : 7 Years & Relevant : 4 Years Notice Period : Immediate to 30 Days Work Timing : 7:30 AM to 5:30 PM IST Role Requirements 5+ years as a Product Owner or similar role Salesforce platform experience Requirements management using Jira Platform integrations (MuleSoft, Integration Fabric, APIs) Data flow understanding and data requirement management Responsibilities Translate product roadmap into actionable requirements Write detailed user stories and acceptance criteria Collaborate with developers and analysts Resolve conflicting user requirements Assist in process modelling a...

Role Overview: As a Lead Medical Writer at Tatvacare, you will be responsible for developing and reviewing high-quality medical content, including scientific publications such as original research articles, consensus, expert opinions, review articles, meta-analysis, case reports, narratives, clinical trial documentation, regulatory submissions, and real-world evidence reports. Your role will involve collaborating with cross-functional teams, providing scientific expertise, and ensuring compliance with regulatory and industry standards. The ideal candidate for this position will have extensive medical writing experience, particularly in clinical development, regulatory affairs, and digital he...

Job Description Summary Radiological Safety Officer (RSO) is responsible for the overall management and implementation of Wipro GE HealthCare Radiation Safety Program. He/She shall discharge his duties as specified in various AERB guidelines and comply with GEHC Radiation Safety requirements. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities AERB Requirements Radiological safety offic...

Opening with a leading Pharma company for their office in Navi Mumbai Role: Director Regulatory Affairs - US post approvals Experience: 15 Years+ Role & responsibilities : Essential Duties & Responsibilities : Define and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs, ensuring alignment with business goals and regulatory expectations. Oversee the preparation, review, and submission of all CMC post-approval regulatory filings, including: CMC Supplements (CBE-0, CBE-30, and PAS), Annual Reports (both active and inactive), REMS updates, general correspondences and controlled correspondences Serve as the primary regulatory authority on ...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 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 align...

Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations: a. Prepare and review variation , ...

Regulatory Compliance Ensure all products comply with Fertilizer Control Order (FCO), Central Insecticides Board & Registration Committee (CIBRC), Environmental, and other statutory requirements. Maintain up-to-date knowledge of changes in fertilizer-related regulations, policies, and guidelines issued by central and state governments. Licensing & Registration Prepare and submit applications for new product registrations, renewals, and amendments under relevant acts. Manage state-wise licenses, permissions, and certifications for the manufacturing, distribution, import, and marketing of fertilizers. Documentation & Dossier Preparation Compile, review, and maintain technical dossiers, safety ...

Drug Regulatory Affairs will be responsible for compiling, reviewing, and submitting dossiers and regulatory documents for drug product approvals in international markets. Prepare, review, & submit (CTD/eCTD/ACTD formats) for new drug applications. Required Candidate profile B.Pharm/ M.Pharm in Life Sciences. 2–5 years of experience in Regulatory Affairs Knowledge of national and international regulatory (ICH,WHO,USFDA). Exp with dossier preparation in CTD/eCTD format.

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.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 client...

Role: Regulatory Affairs Manager Job Location: Pune Exp: 8-14 Years Qualification: B.Pharm/M.Pharm Job Responsibilities: Dossier preparation, Submission, Compilation, Query Response, Variation filling Responsible for pre and post approval activities. Handling Europe Market. Strong knowledge of EU regulatory frameworks and guidelines (e.g., EMA, ICH, eCTD). Experience with dossier preparation in various formats (CTD/eCTD). Experience in leading a team If relevant and interested pls share your cv.

Job Summary: An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device software quality including Software as a Medical Device (SaMD). The ideal candidate will have 310 years of hands-on experience in regulatory strategy, quality systems, and compliance for digital health products and medical device software. This role is critical in ensuring our SaMD offerings meet global regulatory and quality standards across the product lifecycle. Key Responsibilities: Develop and execute regulatory strategies for medical devices including SaMD products across global markets (FDA, EU MDR, etc.). Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO ...

Job Description: 1 . Hands on Experience in regulatory submissions preferably for Blood products and Biologics. 2. Review/Submission of applications for new products Manufacturing licenses and renewals. 3. Experience on procedures for application of new drugs (NOC's and Test licenses). 4. Monitoring and ensuring allp certificates (COPPs, GMP, GLP, WHO-GMP and FSC Production Capacity and Performance Certificate) renewals and approvals up to date. 5. Review of Tender certificate. 6. Co-ordinate with Drug control authority personnel for License approvals. 7. Review of Dossiers. 8. Submission of Samples and Documents to NIB, Noida for testing. 9. Updation of the National and international legisl...

KnJ Projects Private Limited is looking for Material cum Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

SACRED HEART HIGH SCHOOL is looking for Art&Craft Teacher to join our dynamic team and embark on a rewarding career journey. We are seeking a creative and passionate Art Teacher to join our educational institution. The Art Teacher will play a vital role in fostering students' artistic skills, creativity, and appreciation for visual arts. This role is perfect for individuals who are dedicated to inspiring young minds through engaging and innovative art education. Responsibilities : Plan and deliver art lessons that align with curriculum standards and learning objectives. Teach various art forms, techniques, and media, including drawing, painting, sculpture, ceramics, digital art, and more. Pr...

KGVK (NGO & CSR Arm of Usha Martin Limited) is looking for Quality Control/Assurance Professional to join our dynamic team and embark on a rewarding career journey. Develop and implement quality control systems to ensure products meet regulatory and customer standards. Conduct inspections, audits, and testing to identify deviations or defects. Collaborate with production and R&D teams to address quality issues and implement corrective actions. Maintain documentation and compliance with ISO and GMP standards for continuous improvement. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourag...

KGVK (NGO & CSR Arm of Usha Martin Limited) is looking for Quality Control/Assurance Professional to join our dynamic team and embark on a rewarding career journey. Develop and implement quality control systems to ensure products meet regulatory and customer standards. Conduct inspections, audits, and testing to identify deviations or defects. Collaborate with production and R&D teams to address quality issues and implement corrective actions. Maintain documentation and compliance with ISO and GMP standards for continuous improvement. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourag...

Hiring for a ManagerQARA for a leading medical device company Experience -5-12yrs Location -Delhi/NCR Job Profile -Responsible for leading Regulatory and Quality activities in the India Subcontinent geography- India and neighboring countries. responsible for driving regulatory process and strategy pertaining to registration of Company products in India Subcontinent geography & maintain data for registered products. He/she participates in all activities relating to preparation, compilation, submission of dossiers and follow up to obtain approvals/renewals for products and its variations & line extension indications and labeling approvals of medical devices. He/ she will be responsible for int...

Job Description JOB Responsibilities: - Location: Ahmedabad 1. Ensuring the GMP compliance at CMO and Release of batch manufactured for US market at CMU. 2. Monitoring of process starting from dispensing to packing including witness analysis of Lupin products manufactured at CMO for US market and Domestic market. 3. Handling of market complaint with root cause identification and ensuring the CAPA implementation. 4. New product review to be carried out at manufacturing site after availability of all the documents. 5. Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished p...

Organizing, maintaining, and filing regulatory documents golbally, ensuring compliance with regulatory guidelines. Prompt regulatory support to the customers. Collaboration & engaging in periodic customer teleconferences to resolve queries Change control evaluation and plant support Scheduling the life cycle management activities globally for all the regulatory submissions complying with region specific requirements Ensure the Drug Master File (DMF) deficiency letters received from various regulatory agencies globally are responded in time with adequacy and accuracy.

We are looking for a dynamic and detail-oriented Trainee Engineer to join our Compliance and Certification team. You will serve as the communication bridge between our company, manufacturing clients, testing laboratories, and government authorities. Your role involves assisting companies in navigating compliance requirements for products, factories, imports, and exports. Education : - Graduate/Postgraduate in Environmental Science, Business Administration, MBA, Compliance, or relevant field Strong analytical and organizational skills Excellent written and verbal communication Attention to detail and ability to multitask Proficient in MS Office (Word, Excel, PowerPoint) Basic understanding of...

Skills: visa, sales, australia, canada, immigration, visa process, direct sales,. About The Role :-. Designation-Manager Visa. Working closely with Admission and Counselling Team to educate them about changing Student Visa Rules. Lead the team. Will be the process owner for assigned clients (students) and ensuring that they are serviced and guided well from start to finish of the student Visa application process. Ensuring complete visa application documentation including all the financial & background related papers. Helping team to manage the students and providing advice in preparing the visa files. Liaising with the students to confirm that everything is done before the interview date. Li...

Skills: payments of bank, MIS Reporting, Coordination, stock reporting, operation, logistics,. Profile-Operational Logistic-Work from office only. We are Hiring for Arvex Pvt. Ltd. Location-Nehrunagar, Ahmedabad. Payments of bank. MIS reporting for funds & trucks. Coordination for trucks. Nomination Preparing against PMT. Maintaining report for trucks operators. Stock reports. Min. Qualification-Bachelor's degree in logistics, supply chain management, or a related field. Exp-. Min -1 year. Max-3 year. Salary20k to 23k. Apply if you have relevant experience and good communication skills. Roles And Responsibilities. Coordinate with various departments to ensure smooth and efficient processes. ...

Skills: Counseling, Good communication skill, fresher, excellent, counseling, graduate,. We are hiring Visa Counselor for Amritsar location:. Urgently Required Female Visa Counselor who has an experience of. Study visa Canada, Australia, Uk, Usa Visa Counseling. Making telephonic conversations with our clients and making them clear about the visa processes of countries like Canada, Australia, the Uk, USA. Convert leads to admissions. Handling Walk-In, Telephonic & Email inquiries. Fix appointments for counselors and generate walk-ins. Following up on the prospective students over the phone. Follow-up on the leads till registration. Attending regular team meetings to clarify progress and perf...

- NISM 8 (Equity Derivative) must - Strong Understanding of stock market and Financial regulations. - Excellent Analytical and decision making skills - Ability to work under pressure and quick decisions. - MF certification is added advantage

Role Overview: As the Head of Accounts & Finance for a renowned company in Chandigarh, you will be responsible for overseeing the financial operations, including budgeting, financial reporting, compliance, tax planning, and strategy development. Your role will involve managing the accounting team, ensuring the integrity of financial information, and providing strategic recommendations to optimize financial performance while maintaining compliance with relevant laws and guidelines. Key Responsibilities: - Handle accounts for a company with a turnover of 1000+ crores - Demonstrate a strong command over financial systems, ERP, and internal controls - Utilize strong knowledge in Financial Report...