324 Ectd Jobs - Page 9

Role & responsibilities * Data Entry and Updation in Regulatory Information Management System. * Dossier preparation (New/ Renewal/ Variations) for different countries. * Other RA Related Activities. Perks and benefits * 5 days working Environment * Additional Benefits.

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...

RESPONSIBILITIES Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU and/or UK. Experience with AUS-NZ submissions would be an added advantage. Publishing in eCTD format and submission to respective Regulatory Agencies. Compilation and submission of variation applications for EU and/or UK. Review of documents related to compilation of dossiers, variations and query responses. Up to date knowledge of EU regulatory guidelines and requirements. DESIRED SKILLS Must have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycle Should have handled initial MAA submission & Variations for EU. Good technical knowledge w...

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Sea...

Responsible for overseeing al aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market. Developing and implementing comprehensive regulatory strategies for new drug development, including clinical trial design, data submission plans, and market access strategies. Leading the preparation and su...

Planning, review & submission of CTD/ACTD/eCTD for export market (Markets will work for Europe / US). Registration/Re-registration/post approval changes application for export market. Resolve the technical query related to product registration/Re-registration/post approval changes. Follow-up and coordination with internal stakeholders. Review of technical documents. Review of artwork and pack insert. Preparation and submission of Product safety update report.

Medical Device Safety Physician – MBBS/MD mandatory. Review medical device safety reports (ICSR, SUSAR), assess risks, and ensure MDR/EU/US compliance. PV, clinical trials experience required. Required Candidate profile Strong decision-making, regulatory knowledge. WFO (Mumbai/Gandhinagar/Chennai/Pune/Indore). Salary up to 16 LPA.

Preparation of DMFs for different markets in CTD and eCTD formats. Coordination with cross-functional dept to manage the documents. Supporting marketing team & QC/QA/R&D in various capacity. Preparation of Declarations and other supporting docs. Perks and benefits PF CANTEEN TRANSPORTATION

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.

Manager Mobility Industrial Join our team in Strategy & Consulting to find endless opportunities and solve our clients' toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Transportation and Logistics, Industrial Consulting, S&C Global Network (GN) I Areas of Work: Mobility & Transport Solutions| Level: Manager | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad | Explore an Exciting Career at Accenture Are you a problem solver driven by impactful resultsDo you enjoy working on transformation strategies for global clientsDoes a collaborative and inclusive workplace energize you Then, Accenture Strategy & Cons...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare operati...

Qualification: MSc in Analytical / Organic Chemistry Pharmacy Life Science Role Summary: Seeking detail-oriented and motivated regulatory compliance specialists to manage and coordinate regulatory activities related to API filings across multiple regions. Responsibilities include preparing, reviewing, and submitting high-quality regulatory documents to ensure global compliance. Key Responsibilities: Prepare, compile, and submit DMFs, ASMFs, and API regulatory dossiers to global authorities. Ensure timely updates, maintenance, and life cycle management of submissions. Monitor global regulatory changes and communicate to internal teams. Handle customer queries, letters of access, and technical...

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 ABAP Cloud Good to have skills : NAMinimum 7.5 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 that application development aligns with business objectives, overseeing project timelines, and facilitating communication among stakeholders to drive successful ...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor of Pharmacy/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 ...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications are optimize...

Senior Biostatistician (9-18 yrs exp, PhD/Postgrad in Stats)to lead clinical trial design, statistical analysis, and TLG development. Responsibilities include protocol development, ADaM specs review, statistical QC, and ensuring regulatory compliance Required Candidate profile Must collaborate with cross-functional teams, support submissions, and drive innovative methodologies. Exp in SAS/R, clinical reporting, and adaptive designs preferred. (20-24 LPA, PAN India).

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....

Role & responsibilities 1. Regulatory Submissions and Approvals: Prepare and submit dossiers for product registrations in ROW, Africa, LATAM, CIS, and ASEAN markets, ensuring adherence to country-specific guidelines and requirements. Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions. Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies. 2. Compliance and Documentation: Ensure compliance with local regulatory requirements, guidelines, and international standards (such as WHO, ICH, or country-specific regulati...

Knowledge of about Preparation of Dossier. Sound knowledge of about semi regulated and regulated markets like USFDA , EU , MHRA , TGA , ANVISA , Canadian market. Knowledge of addressing regulatory deficiencies. Exposure to regulatory audits. Review of DMF. Knowledge of filling the products to semi regulated markets and regulated markets. Location Hyderabad Apply to Job Send your resume to

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Bilaspur. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform various tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of t...

We are looking for a highly motivated and experienced Customer Relationship Executive to join our team in Kanpur. The ideal candidate will have 2-5 years of experience in sales, customer relationship management, or a related field. Roles and Responsibility Achieve assigned collection targets for SLCV&PV (in the 0-3 range) through effective collection strategies. Ensure timely recovery of dues and maintain strong customer relationships by monitoring accounts and ensuring compliance with legal and company policies. Develop and implement customer management plans to meet daily visit and customer target requirements. Regularly contact existing clients to maintain company presence and identify ne...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Lucknow. The ideal candidate will have 1 to 6 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Sup...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Hubli. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervis...

We are looking for a highly motivated and customer-focused individual with 0 to 3 years of experience to join our team as a Customer Service Executive in Coimbatore. The ideal candidate will have excellent communication skills and the ability to work effectively in a fast-paced environment. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager, including identifying potential business customers. Collect and validate customer documents according to organizational norms. Log cases in the system following SOPs and processes for disbursement. Fulfill sanction ratios as per organizational requirements. Meet customer needs and cross-sell multiple products with the hel...