38 Submission Jobs - Page 2

Ensure that submission of CTD, eCTD, aCTD dossiers. Meet all regulatory requirements. Participate in contacting competent authorities for respective products. Preparation of regulatory submissions (Dossier, Variations) to authorities. Required Candidate profile Should have deep knowledge of Preparation and submission CTD, eCTD and ACTD Dossiers to ROW drug regulatory authorities. Should be able to handle queries, Artworks check, regulatory planning.

Job Description: Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per EAEU 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 on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

Jobon International Pvt Ltd Empowering Caregivers, Enhancing Lives Jobon International Pvt Ltd is a pioneering organization dedicated to providing comprehensive training programs for caregivers. Our mission is to equip individuals with the necessary skills and knowledge to deliver exceptional care and support to those in need. Caregiver Training Centre at Kurla West Our state-of-the-art training centre at Kurla West is designed to provide a supportive learning environment for aspiring caregivers. Our experienced instructors and cutting-edge facilities ensure that our students receive the best possible training. Join Our Team! We are currently seeking a highly motivated and organized individual to join our team as a Submission Clerk cum Accountant. Walk-in Interview We invite eligible candidates to attend a walk-in interview for the position of Submission Clerk cum Accountant. Job Details: - Position: Submission Clerk cum Accountant - Location: Kurla West, Mumbai - Job Type: Full-time - Experience: 1-2 years - Qualification: (link unavailable) Responsibilities: - Manage and maintain submission related works -present at submission center and other relevant places - Manage and maintain accurate financial records - Prepare and submit financial reports - Assist in budgeting and forecasting - Coordinate with auditors and regulatory bodies - Perform other accounting and administrative tasks as required Requirements: - Willingness to work indoor and out door - Strong accounting and financial management skills - Excellent communication and interpersonal skills - Ability to work accurately and efficiently in a fast-paced environment - Proficiency in accounting software and Microsoft Office Office & Interview place address:- Jobon International Private Limited RA LIC. NO. B-2263/DEL/COM/1000+/5/10712/2024 329,G-Wing, Kanakia Zillion, BKC Annex, Shastri Marg, Rupa Nagar, Kapadia Nagar, Kurla (w), Mumbai, Maharashtra-400070

We are seeking a qualified and experienced Senior Officer/Executive to join our Regulatory Affairs Team. The ideal candidate will specialize in preparing, compiling, and reviewing regulatory dossiers in compliance with international standards and regulatory authority requirements, with a focus on South Africa and other country-specific markets. Roles & Responsibilities: Dossier Preparation and Review: Compile and review high-quality CTD dossiers and variations as per South Africa and other country-specific requirements, including electronic dossier (dB) compilation and publishing. Prepare high-quality eCTD dossiers for new submissions, variations, and responses tailored to regulatory requirements. Agency Communication and Submission: Develop and submit quality responses to agency queries within specified timelines. Collaborate with South African counterparts and principals to validate and electronically publish regulatory documents. Documentation and Compliance: Review and manage scientific and technical documents, including DMFs, CEPs, and drug product-related documents, ensuring adherence to regulatory requirements. Prepare, update, and review product labeling and information. Cross-functional Collaboration: Coordinate with RD&I, manufacturing sites, customers, and principals to gather required documents for dossier compilation. Manage notifications and documentation for implementation of amendments. Regulatory Process Management: Ensure documentation practices align with organizational and regulatory standards. Maintain organized and accurate records for all regulatory activities.Role & responsibilities Requirements: Bachelors or Master’s degree in Pharmacy (B. Pharm or M. Pharm). Proven experience in regulatory affairs, with a specialization in dossier preparation for South Africa or similar markets. Proficiency in electronic publishing tools and CTD/eCTD dossier formats. In-depth understanding of South Africa-specific regulatory guidelines. Strong organizational, communication, and documentation skills. Ability to prioritize multiple projects and meet strict deadlines. Collaborative team player with a proactive and detail-oriented mindset.

Location: Medicover Hospitals, Corporate Office Work Schedule: 6 Days a Week Experience Required: 1 to 3 Years (Hospital Corporate Billing Experience is Mandatory) Industry: Healthcare/Hospital Job Summary: Medicover Hospitals is seeking a Billing Executive Corporate Billing to manage and oversee hospital corporate billing processes. The selected candidate will be based at the Corporate Office and will be responsible for ensuring accurate, timely, and compliant billing for corporate patients, TPAs, and insurance cases across our hospital network. Key Responsibilities: Handle end-to-end corporate billing processes for hospital services, including TPA, insurance, and corporate client invoicing. Verify patient details, approvals, and contractual agreements before processing bills. Ensure invoices are generated as per agreed corporate tariffs and hospital billing policies. Coordinate with hospital billing teams, finance, and corporate clients for smooth processing. Address and resolve billing discrepancies, queries, and payment-related issues. Ensure compliance with hospital pricing structures, GST regulations, and corporate contracts. Monitor outstanding payments and follow up with stakeholders for timely collections. Maintain billing records, generate periodic reports, and assist in audits. Support process improvements to enhance corporate billing efficiency. Required Skills & Qualifications: Educational Qualification: Bachelor’s degree in Commerce, Finance, Business Administration, or a related field. Experience: 1 to 3 years of experience in hospital corporate billing (experience in a hospital setting is mandatory). Strong understanding of corporate billing, TPA processes, and hospital revenue cycle management. Proficiency in hospital billing software and MS Excel. Excellent communication, coordination, and stakeholder management skills. High attention to detail and problem-solving abilities.

Looking candidates for Regulatory Affairs-South Africa Market Experience : 7 -13 Years Job Location: Andheri Mumbai Qualification: M. Pharm/ B.PHARM+PG IN RA Job Description: 1. Management of product lifecycle for South Africa Market. 2. Dossier Preparation 3. Query Response 4. Post Approval changes 5. Variation Filing 6. Coordination with cross functional team 7. Module 1-5 8. Preparation and compilation of administrative, quality & Safety application (Eg. Type IA,IB Type II) 9. Reviewing Product information as per QRD Requirement 10. Should have strong knowledge of CTD dossier and must have experience of team handling. 11. Risk Assessment and Mitigation: - Identify potential regulatory risks, develop mitigation plans and adapt strategies accordingly to minimize risks. 12. Provide regulatory guidance and support to other departments as needed. Thanks & Regards Mayuri

Role & responsibilities 1. Preparation & compilation of dossier in ACTD, CTD & country specific format according to guidelines of various countries. 2. Timely compile documents for license renewals, update and re-registrations. 3. Review of technical documents like BMR, Stability, Spec-STP,PVP-PVR,PDR required for dossier compilation. 4. Collect and co-ordinate information and compile regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy. 5. Response to query/deficiency/Notice of Deficiency raised by Drug Regulatory Authority or technical representative. 6. Stakeholder Engagement. 7. Cross-functional Collaboration. Preferred candidate profile M. Pharma (Pharmacy)/B.Pharma ( Pharmacy) Perks and benefits

SUMMARY Job Opening for US Claims Professionals at a Leading Multinational Corporation in Mumbai-Airoli Position: US Claims Specialist We are currently seeking individuals with demonstrated expertise in managing US claims, specifically in the assessment of previous claims and efficient handling of current claims. Minimum Qualifications: Completion of a Bachelor's degree 1 year of practical experience in US claims Key Skills: Outstanding verbal and written communication abilities Proficient in MS Office applications (Excel, Word, and PowerPoint) Willingness to work night shifts (US shift timings) Submission of all academic transcripts up to the final semester of graduation without any pending courses, Aadhar card, and PAN card Additional Requirements: Residing within a 30 km radius of Airoli Shift Timing: 5:30 pm to 3:00 am Immediate availability is preferred Requirements Requirements: Bachelor's degree 1 year of experience in US claims Excellent verbal and written communication skills Proficiency in MS Office tools (Excel, Word, and PowerPoint) Flexibility to work night shifts Submission of all academic transcripts up to the final semester of graduation without any pending courses, Aadhar card, and PAN card. Benefits Salary: 30000/Month CTC PF ESI BOTH WAY CAB WORK FROM OFFICE

Responsibilties - Prepare submission drawings as per rules & regulations Convert into online submission software and submit to authority Know the PMRDA, SRA and UDCPR rules Make feasibility report to prepare for redevelopment Work out sanction cost to give finance department Finalise the land demarcation Coordinate with all departments and sites for documentations Required Skills Online submission knowledge of softwares Rules and regulations Excel/Word and email writing

Role & responsibilities - Review, compile and submit the Application dossiers (ANDA, MAA) to regulatory agencies like US-FDA, EMA, Health Canada, Australia and ROW countries. - Review and approve regulatory CMC documents being generated at R&D and commercial manufacturing facility such as development reports, BMR, BPR, Specifications, method validation reports, process validation reports, stability protocols, stability data etc. and ensure regulatory compliance. - Maintenance of the complete history of each Drug products (Filing history with agencies/customers, amendments).To coordinate in regulatory audits and provide regulatory support. - Coordination with internal and external stakeholders for regulatory filing related documentation. - Communicate the agency's comments/deficiencies to respective in house departments, prepare the response and submit it back to the agency. - Hands on experience of post approval variations and Annual reports. Preferred candidate profile Master of Pharmacy Perks and benefits As per Company Standards

Should have exp in Regulated(EU /US) Pre-approval filings New marketing authorizations New dossier submissions to regulatory agency Review technical documents prepare Type IA /IB/II variations prepare submissions license variations & renewals Required Candidate profile Candidates having experience in Regulatory Affairs of Regulated Market should only apply Excellent written and verbal English communication

Job description:- Review of Drug master file (DMF) Evaluation Of analytical Documents - Specifications, method Validations Checking Pharmacopoeial Change with respect to DMF Submissions Familiar with life cycle Management of DMD Changes good command over spoken and written English well Versed with working on computer

Greetings from BVR People Consulting!! Position: Regulatory Affairs - Formulation Designation: Executive or Asst. Manager Division: Injectable and Solid oral products Qualification: B. Pharm, M. Pharm and M. Sc (FULL TIME) only Years of Experience: 4 to 8 Years CTC range: 5 to 13 LPA. Job Locations: Bangalore ( Electronic City ) No. of Positions: 04 Job Summary: Compilation and submission of the dossier and query responses as per the EU/UK/ANZ /Israel/Belarus and Ukraine regulatory requirements within stipulated timeframe (for Injectable and Solid oral products ). Interaction with CFTs for product specific requirements and to attend product strategy meetings. Review of final data and technical documents received towards dossier compilation from API team, RnD, IP, PV, QA, Commercial, Packaging and Plant team. Compilation of labelling documents as per current EU/UK/ANZ/Israel/Belarus and Ukraine regulatory requirements. eCTD Publishing of dossiers in DocuBridge software. Product life cycle management for approved Europe products i.e. variation, Renewal and sunset exemption filings. Maintain product database, regulatory files, records and reporting systems. Timely updation and maintenance of RIMS database. Preparation and submission of high-quality national translations for National Phase. Post Approval and Pre approval NOTE: We are looking Notice period 01 month or immediate joiner. Interested Candidates should forward their resume to " ganapathi@bvrpc.com" and also Your Current CTC, Excepted CTC and Notice period. Thanks K Ganapathi Mob. No. 9600387468