9 Dossier Submission Jobs

Job Description Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla Travel: Low Job Overview The Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities, country distributors or external partners. Will work closely and train other junior regulatory staff. Key Stakeholders: Internal External partners, Country Distributors, Health Authorities Key Stakeholders: External Cross-Functional Teams Reporting Structure Reports to: Senior General Manager-Regulatory Affairs Direct Reports: Yes Essential Qualification & Experience Master&aposs in Pharmacy degree, full time (Regulatory Affairs certification is preferred) Minimum of 8 to 10 years of experience in a pharmaceutical regulatory affairs department. Experience in leading dossier submission to Latam/ ROW markets and post approval variations. Key Responsibilities Work closely with internal and external manufacturing sites to. assess post approval product chemistry, manufacturing and control (CMC) changes and determine appropriate global filing strategy Manage the assembly, compilation, submission and electronic publishing (if required) of documentation for product compliance, registration and life cycle maintenance. Support regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, product development and review, and other strategic deliverables. Evaluate business opportunities and perform regulatory due diligence for in licensing and product acquisition for assigned region. Maintain up-to-date knowledge of data requirements, applicable SOPs, policies, regulations, guidelines, and industry standards. Knowledge areas include ICH, WHO, GMP, USP, stability, validation, and US regulations. Review and interpret pertinent regulations and guidelines to develop proactive solutions to regulatory issues and challenges and communicate them to the other team members and functionalities within the organisation Competencies Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders Expert knowledge and proficiency at interpreting regulatory guidelines. Possess excellent abilities to draft the CMC section of dossier Strong analytical, conceptual, problem-solving, and decision-making abilities Effective collaboration skills Proactive, with a strong ability to learn and adapt Advanced skills in Microsoft Office Suite (Excel, Word, PowerPoint, and Access) Critical Thinking using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems Proficient in both verbal and written communication Ensuring the maintenance of confidentiality at all times Capable of presenting multiple solutions creatively Displaying enthusiasm and a positive attitude Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders. PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators. Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space. Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment. Show more Show less

If you are a Project Engineer Specialist, Emerson has an exciting role for you! We are looking for an Instrumentation Project Engineer to work for our Pressure Management Business unit at Mahindra World City, Chengalpattu. You will need to have good knowledge and skills in skid assembly, electrical wiring, instrumentation, AGA codes, and meeting customer/project technical specifications. Your responsibilities will include liaising with third parties on testing the skids and obtaining approvals/clearance. You will also be analyzing drawing, GAD, P&ID inspection techniques, control plans, and quality plans. Your responsibilities will involve having a good knowledge of ISO standards, expertise in reading P&ID, ISO drawings, and GAD as defined by the design team or customer. Experience in understanding engineering documents and datasheets is required. You should be able to read loop diagrams, PLCs, and wiring diagrams for instruments. Knowledge of instrument hook-up drawings, MTO preparation, cable schedules, JB schedules, and various instrument items is essential. Additionally, you should possess validated knowledge in items like gauges, transmitters, control valves, switches, flow meters, flow computers, EVC, cables, positioners, cable trays, and instrument fittings. You will be responsible for inspecting and verifying electrical wiring as per approved drawings, educating assembly operators and electricians with approved drawings, wiring diagrams, etc. Tender reading, document preparation, RFQs, reviewing offers, coordinating with vendors, entering part codes, uploading BOM to Oracle, and closing punch points are part of your duties. You will work closely with internal team members, suppliers, and customers throughout the Skid Execution, Factory Acceptance Test (FAT), and Commissioning process. Submitting the dossier to customers promptly is also expected. To succeed in this role, you should have a good knowledge of reading P&ID diagrams and instrumentation diagrams, expertise in flow computers, PLCs, problem-solving techniques, and proficiency in basic computer skills for report preparation. Being able to work independently, lead instrument functions, maintain detail error on TPI zero, and minimize nonconformance during in-house production and testing are essential. Preferred qualifications include a BE in Instrumentation or equivalent experience with valid experience. At Emerson, we prioritize a workplace where every employee is valued, respected, and empowered to grow. We foster an environment that encourages innovation, teamwork, and diverse perspectives. Our commitment to ongoing career development and an inclusive culture ensures you have the support to thrive. We provide competitive benefits plans, medical insurance options, employee assistance programs, recognition, and more. Our culture offers flexible time off plans, including paid parental leave, vacation, and holiday leave.,

US (FDA) Regulatory Support: Prepare and submit: 510(k) premarket notifications,PMA,supplements or De Novo requests (if applicable),Support establishment registration Medical device listing, Ensure compliance with 21 CFR Part 820 (QSR) and UDI Office cab/shuttle Annual bonus Health insurance Provident fund

Job Responsibilities: Dossier preparation/review as per country specific guideline/CTD guideline Timely query response submission to Distributor/ MOH Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement) Preparation, review & release of artworks & sales order as per country approval Variation documents preparation and filing as per country requirements Timely dispatch of tender documents to country/parties as per deadline Candidate profile Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH Should be able to review various plant documents for dossier preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master File, BMR, APR etc. Should be able to communicate with relevant functions for procurement of required regulatory documents Should be able to communicate with relevant business partner at country

Looking for someone from chemical background not pharma Relevant Experience with Skills and Key Responsibilities: Responsibilities 1) The regulatory specialist will assist IDS senior staff to research (monitor, analyze and create) content regarding global chemical regulatory compliance for industrial / specialty / household /cosmetics / agricultural /pesticides / biocides hazardous and non-hazardous chemicals and products. 2) Strong regulatory research and analytical skills as demonstrated by 2+ years relevant industry experience 3) Ability to understand and apply scientific, and technological knowledge and the regulatory law to the particular needs of the customers in global geographies for chemicals management and control solutions 4) Preparation of regulatory research report for various products in different geographies such as EU, US, China, India, Korea, ASEAN, and other countries 5) Working knowledge in EU REACH registration services, dossier submission via IUCLID 6, and full registration services; good knowledge of Safety Data Sheet Key Features: 1) Critical thinking regarding information and process 2) Excellent English report writing skills 3) Mon-Fri 9.5 hours per day including lunch, tea etc. 4) WFO (preferred) or Flexi or WFH 5) Self-motivated, with Excellent time management 6) Passion to learn new information and to build on existing knowledge 7) Experience in providing the chemical and chemical product consultancy services 8) Experience in regulatory compliance / regulatory affairs 9) Additional non-English international language skill is a plus Location - Remote,Chandigarh,Ahmedabad

Role & responsibilities We are seeking a detail-oriented and knowledgeable Executive Drug Regulatory Affairs to manage the preparation, compilation, submission, and post-submission activities related to herbal formulation dossiers for domestic and international regulatory authorities. The ideal candidate should have a strong understanding of herbal product regulations, excellent documentation skills, and the ability to manage regulatory queries effectively. Key Responsibilities: Prepare, review, and compile regulatory dossiers for herbal medicinal products in compliance with country-specific regulations . Ensure that all documents are accurate, complete, and meet submission timelines. Coordinate with cross-functional teams including R&D, Quality, Manufacturing, and Marketing to gather required data and technical documents. Submit regulatory dossiers to appropriate health authorities and track submission status. Respond to regulatory queries promptly and effectively with appropriate justifications and additional documentation. Keep up to date with evolving regulatory requirements for herbal and traditional medicines across various markets. Maintain regulatory databases, submission trackers, and ensure documentation compliance with internal and external standards. Assist in the preparation of product labels, artworks, and promotional materials from a regulatory compliance perspective. Qualifications and Skills: Education: B.Pharm / M.Pharm / M.Sc. (preferably in Pharmacognosy, Pharmaceutical Sciences, or a related field) Experience: 2–5 years of experience in Regulatory Affairs with specific focus on herbal or traditional formulations . Familiarity with regulatory frameworks such as AYUSH , WHO-GMP, ASEAN Guidelines, EU Traditional Herbal Medicinal Products Directive, etc. Excellent written and verbal communication skills. Proficient in MS Office (Word, Excel, PowerPoint). Strong attention to detail and organizational skills. Ability to handle multiple projects and deadlines. Preferred candidate profile

Regulatory Submissions Publisher – Mumbai/Bengaluru (Night Shift). Prepares & QC’s regulatory dossiers (IND, NDA, CTA, BLA, IMPD, MAA) for US, EU, Canada, ANZ. Handles EDMF, COS/CEP, MRP/DCP/CP filings Required Candidate profile Requires 2+ yrs pharma publishing exp, Documentum/Liquent Insight skills, MS Office proficiency. Must have international BPO exp, grad degree, and be based in Mumbai/Bangalore. No ex-TCS candidates.

Key Responsibilities will include : 1) Experience in technical review and compilation of registration dossiers for regulated markets. 2) Review of master documents (Specifications, MFR, BMR, BPR, PVP, PVR, HTSP, HTSR, PDR, elemental impurity risk assessment, nitrosamine risk assessment, stability protocols), DMF. 3) Deficiency management for products filed to regulated markets.

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.). QC submission dossiers or parts of submission dossier output of low-to- moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission- ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; and Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre- established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties Problem solving skills Management of team Knowledge of business principles. Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 2or more years of experience in pharmaceutical industry submission publishing or related technical skills c) Familiarity with FDA or EU regulations & guidelines To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Noida Search : Copy and Paste the link below https://outpace.in/job/regulatory-submissions-publisher-4/