59 Dmf Jobs - Page 2

Review the Lab validation Protocol and Report of CRD Review of Process Development report for DMF filing. Required Candidate profile Lead the DQA department to implement CGMP rules and regulations in Research & Development.

Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Company: Job Overview: As a Project Manager, you will play a key role in coordinating with partners and stakeholders to ensure the successful delivery of critical business projects. Project Managers will navigate barriers and work closely with functional team members to guide each project to completion. This role requires cross-functional collaboration and impeccable organization skills to deliver projects in a timely manner and within budget. Minimum Qualifications: Bachelor's degree 5+ years of Project Management-relevant work experience in Finance 2+ years of managing operating budgets and/or project financials. 2+ years of work experience in a role requiring interaction with senior leadership (e.g., Director level and above). 2+ years of work experience in change management PMO, PMP, Agile Methodology or Six Sigma Project Management Certification. Principal Roles and responsibilities Gathers stakeholder needs and goals with guidance and executes communication plan for project team and stakeholders. Forms project team, and manages and prioritizes the work of the project team by establishing schedules and task assignments, and tracking tasks of team members. Creates project goals and prioritizes deliverables with guidance from project stakeholders. Create roadmap and plan for change management, assess change impact. Apply a structured methodology and lead change management activities, support communication efforts, Manages multiple projects of small to medium size or complexity and applies up-to-date project management knowledge to meet deadlines. Builds and execute project plans for small- to medium-sized projects which include schedule and resource forecasting, stakeholder identification, method and frequency of communication, scope, and prioritization. Identifies project issues and risks and creates a risk mitigation plan for small- to medium-sized projects. Manages project performance (e.g., on time, on budget, within scope, and with quality) for projects of small to medium size or complexity. Promotes project vision and objectives within project team and ensures project objectives are met. Supports the compliance of project plans by following best practices and procedures. Promotes collaboration with diverse project stakeholders. Level of Responsibility Taking responsibility for own work and making decisions with limited impact; impact of decisions is readily apparent Solid understanding of how people go through a change and the change process with knowledge of change management principles, methodologies and tools. Using verbal and written communication skills to convey basic, routine information about day-to-day activities to others who are fully knowledgeable in the subject area. Completing tasks that require multiple steps that must be performed in a specific order, using directions or manuals that accurately document the steps necessary to perform the tasks. Using deductive problem solving is required to solve moderately complex problems; most problems have defined processes of diagnosis/detection; some data analysis may be required. Exercising some creativity may be required to troubleshoot technical problems or deal with novel circumstances. Minimum Qualifications: Bachelor's degree. 4+ years of Finance, Accounting, or related work experience. *Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Experience Level- 5+ Years, Project/Change certified + successfully delivered Shift timing- EMEA shift (3 pm IST to 12 am IST), but should be flexible based on business needs Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact Qualcomm Careers.

Preparation of Technical documents like below: COA/ Certificate of Analysis Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial Management, Monitoring, and Engagement (CTMME) product team. Build technical solution per implementation project plan by working with various members of the product team and business partners. Conduct user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the study Support requirements gathering and specification creation process for the development work. Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements Participate and contribute to process product or standard methodologies initiatives and support developers and testers during the project lifecycle. Define, author, and present various architecture footprints i.e. Business, Logical, Integration, Security, Infrastructure, etc. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Identify and resolve technical challenges/bugs effectively . Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science Bachelor’s degree with 6 - 8 years of experience in Computer Science Diploma with 10 - 12 years of experience in Computer Science. Preferred Qualifications: Solid technical background, including understanding software development processes, databases, and cloud-based content systems. Experience with Python scripting, SQL queries, markup languages (XML, JSON) and familiarity with API-driven content delivery. Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements. Experience with product backlog management (e.g., Jira) and collaboration tools. Good-to-Have Skills: Experience with structured content management, content models, and modular content creation. Understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, CDS, USPI etc.) Basic understanding of GenAI solutions. Good communication skills, with the ability to convey complex technical concepts. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management . Key Responsibilities Include: Generate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop global dossiers for CMC content for initial submissions, variations and amendments Support change management activities Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment Knowledge and Skills CMC- specific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

,,, Position Summary: You will serve as a key technical liaison between customers and PrintForm's internal teams. This includes reviewing CAD models, offering DFM guidance, supporting quotation generation, and helping ensure successful part delivery, especially for CNC-machined and injection-molded components. Key Responsibilities: Design for Manufacturability (DFM) Analyse 3d CAD models and technical drawings to evaluate the manufacturability of parts. Provide DFM feedback for CNC Machining and Injection Molding processes, optimising for quality, cost, and lead time. Recommend design modifications to improve process efficiency and reduce manufacturing risk. Technical Quoting & Cost Estimation Assess part complexity, material requirements, tolerances, and finishes to support accurate quoting. Collaborate with the global supplier network to gather manufacturing feasibility data and cost inputs. Assist sales and project teams with technical insights for competitive quoting. CAD & Documentation Review Interpret engineering drawings and CAD data to validate technical accuracy. Ensure clear communication of technical requirements to suppliers and internal teams. Maintain documentation related to project specs, drawings, and customer interactions. Supplier Collaboration & Manufacturing Support Work closely with manufacturing partners to align expectations on process capability, tolerances, and delivery schedules. Troubleshoot production issues and support resolution by coordinating with suppliers and engineering teams. Drive quality assurance by validating that manufactured parts meet customer and PrintForm specifications. Customer Communication & Project Coordination Participate in customer calls to provide engineering guidance and clarify technical queries. Act as the technical liaison between customers, suppliers, and internal teams to ensure smooth project execution. Guide customers from prototype to production, focusing on manufacturability and scalability. Continuous Improvement & Knowledge Sharing Contribute to internal knowledge bases and best practice documents. Identify recurring technical challenges and suggest improvements to quoting, DFM, and production workflows. Stay updated on the latest CNC and injection molding technologies, tools, and materials. Cross-Functional Team Collaboration Collaborate with U.S.-based engineering, sales, and project management teams. Support the execution of multi-disciplinary projects across industries such as aerospace, medical, and consumer products. Maintain strong, proactive communication across global teams. Required Qualifications: Bachelor's degree in Mechanical or Manufacturing Engineering. Minimum of 4+ years of relevant experience in CNC Machining and Injection Molding. Proficiency in GD&T, machining fundamentals, mold design, and material properties (both plastics and metals). Skilled in CAD tools like SolidWorks, Fusion 360, or similar. Strong written and verbal communication skills in English. Proven ability to manage multiple projects and work in cross-functional, remote teams. Preferred Experience: Experience in customer-facing or applications engineering roles. Familiarity with cloud-based quoting or manufacturing platforms. Exposure to other manufacturing processes such as Die Casting and Sheet Metal Work Schedule: Night Shift (to align with U.S. time zones) Full remote flexibility within the defined shift hours Benefits: Performance-based incentives Remote work flexibility Health Insurance Opportunities for professional growth and global collaboration Why Join PrintForm? Be part of a fast-paced, innovation-driven global manufacturing company Work with U.S. and international customers and top-tier suppliers Gain exposure to diverse projects in aerospace, medical, energy, and more Contribute to a team where engineering talent is valued and supported

Manufacturing Engineering Design Manager Job Title: Manufacturing Engineering Manager Location: Mysore Karnataka Industry: Consumer Appliances / Food Tech Reporting To: Operations Head Job Summary The Manufacturing Engineering Design Manager will be responsible for overseeing the process development and manufacturing engineering of product at a contract manufacturer (CM). This role will ensure the successful transition of product design to scalable and cost-effective manufacturing, maintaining high quality and reliability standards. The candidate will collaborate with design, quality, and supply chain teams to establish robust production processes and drive continuous improvement. Key Responsibilities Manufacturing Process Development & Optimization Lead the development, validation, and optimization of manufacturing processes at contract manufacturers. Ensure Design for Manufacturability (DFM) & Design for Assembly (DFA) principles are integrated into product development. Develop and implement scalable automation and lean manufacturing solutions. Drive process standardization and ensure best practices across contract manufacturing sites. Supplier & Contract Manufacturer Management Select, evaluate, and onboard contract manufacturers based on technical capabilities, quality standards, and cost-effectiveness. Define manufacturing process requirements, line setup, and equipment specifications at CM facilities. Conduct process capability studies (Cpk, Ppk) and risk assessments (PFMEA, DFMEA). Establish and monitor key performance indicators (KPIs) for CM performance in yield, quality, and cost. Quality & Compliance Ensure compliance with regulatory and industry standards (ISO, FDA, CE, UL, etc.). Implement Statistical Process Control (SPC) and process validation (IQ, OQ, PQ). Develop corrective and preventive action plans (CAPA) for process deviations. Collaborate with the Quality team to establish robust inspection and testing protocols. New Product Introduction (NPI) & Engineering Change Management Lead the industrialization of new product variants and improvements at CM sites. Manage Engineering Change Orders (ECOs) and ensure smooth transitions in manufacturing. Support product cost-down initiatives through value engineering and material/process optimization. Cost & Efficiency Management Develop cost models for manufacturing processes and drive cost reduction initiatives. Optimize production efficiency, yield, and cycle time through Lean, Six Sigma, and Kaizen methodologies. Work closely with supply chain and procurement teams to ensure cost-effective sourcing. Cross-functional Collaboration Work closely with R&D, Product Design, Quality, and Supply Chain teams to ensure seamless integration between design and manufacturing. Provide technical support for troubleshooting manufacturing issues at CM facilities. Drive a culture of continuous improvement through problem-solving methodologies (8D, A3, Root Cause Analysis). Key Deliverables Successful Industrialization Develop and implement manufacturing processes ensuring smooth production ramp-up at CM. Process Qualification Establish and validate critical manufacturing processes to meet quality and cost targets. Supplier Performance Management Maintain CM performance metrics and drive improvements in yield, OEE, and cost. Cost Reduction & Efficiency Identify and implement cost-saving opportunities in manufacturing operations. Manufacturing Readiness Ensure production readiness for new product introductions and engineering changes. Regulatory Compliance Maintain adherence to industry and regulatory standards. Required Qualifications & Skills Bachelor's/Masters degree in Mechanical, Manufacturing, Industrial Engineering, or related field. 15+ years of experience in manufacturing engineering, process development, or industrialization. Strong expertise in consumer appliances, food tech, or electromechanical assembly. Hands-on experience in working with contract manufacturers, including supplier qualification and onboarding. Proficiency in Six Sigma, Lean Manufacturing, and process improvement methodologies. Knowledge of regulatory standards (ISO 9001, FDA, CE, UL) and compliance requirements. Experience with DFM, DFA, PFMEA, and SPC tools. Strong project management, analytical, and problem-solving skills. Excellent communication and stakeholder management abilities. Qualifications: Bachelors degree in Engineering or a related field; Masters degree preferred. Minimum of 10 years of experience in quality assurance/engineering, with at least 5 years in a managerial role. Strong understanding of Manufacturing Engineering methodologies, tools, and processes. Send updated CV- Mobile 91-9590270707 Email:- sp@intellisearchonline.net

Role & responsibilities DMF, CTD, eCTD, ROW LOA, API & FP Declarations, Technical, Clinical & Non-clinical, BE studies, RMPs and PSURs Preferred candidate profile Perks and benefits

Role & responsibilities DMF, CTD, eCTD, ROW LOA, API & FP Declarations, Technical, Clinical & Non-clinical, BE studies, RMPs and PSURs Preferred candidate profile Perks and benefits

Role & responsibilities DMF, CTD, eCTD, ROW LOA, API & FP Declarations, Technical, Clinical & Non-clinical, BE studies, RMPs and PSURs Preferred candidate profile Perks and benefits

Role & responsibilities DMF, CTD, eCTD, ROW LOA, API & FP Declarations, Technical, Clinical & Non-clinical, BE studies, RMPs and PSURs Preferred candidate profile Perks and benefits

We have been retained by a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development to hire a "Consultant - Regulatory Affairs" to be based at their HO located at Navi Mumbai. Details of the position are mentioned below: Company: Our Client is a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development. They have their head office in Mumbai and subsidiaries in Europe, Singapore, Australia and Malaysia. They have been providing high quality & credible consulting services to the Pharmaceutical Industry in India and internationally. They have a young and committed team of GMP and Regulatory Experts. Role & responsibilities: The person will be responsible for Regulatory consulting services at the firm. The responsibilities of this position include, but are not limited to, the following: Ownership for assigned regulatory projects including dossier writing, submissions, approval tracking, query resolution across Developed markets (UK, Australia, EU and US) and Emerging markets Ensure regulatory compliance, accuracy, timely completion, version control & adherence to internal SOPs Providing strategic input to the Management and Partners on regulatory projects Keep abreast of new developments in regulations across all critical health authorities Experience & Qualifications Regulatory affairs experience in small molecules for a minimum of 3-8 years is mandatory Must be well versed with ICH CTD guidelines and other regulatory guidelines from developed markets (US, EU, UK etc). Must have hands-on experience in regulatory submissions pertaining to generics/ small molecules (m1-m5 CTD writing for EU, Australia and other markets) CEP/ DMF/ ASMF filing with a good knowledge of EDQM requirements would be advantage. Experience in biologics/ biosimilar filings will be an added benefit. Computer and technical skills (including eCTD software knowledge) Strong & Flawless communication skills. Accuracy and attention to detail. Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak, Director, Pharma Placements Inc. Mobile: 98202 34987 / 81307 24980

- Must have good knowledge of Regulatory Submissions and Research - Must be familiarity with chemical industry specific regulations and guidelines. - Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies Required Candidate profile - Ensure company products with relevant regulatory requirements such as USFDA, FDA, EMA, and local regulations. - Stay up-to-date with changing regulatory requirement to internal stakeholders.

Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers Coordinate with factory Required Candidate profile 1-3 Years Experience In Regulatory Affairs for formulations Excellent communication skills both written and verbal

To prepare Standard Operating Procedures of all departments. To review batch manufacturing records protocols and reports of all Active Pharmaceuticals Ingredients and Intermediates to support DMF / FILING. Follow quality assurance systems as per cGMP guidelines. To ensure that all manufacturing operations at the location comply with ICH Q7 system, documentation and records. To follow a system for releasing or rejecting all APIs. To follow up a system for releasing or rejecting intermediates for use outside the control of the manufacturing company. To follow a system to release or reject RM, Intermediates, packing and labeling materials. To perform product quality review. To prepare product labels and establish a system to control issuance of labels. To review raw data of analysis before release of the batch. To support Asst. Manager / Officer for Q.A activities like qualification, validation, calibration, and area monitoring. To prepare documents for customer questionnaires and support. To prepare, review and respond to the Regulatory Query. To fill the customer vendor questionnaire as per customer requirement & provide VQ related declaration. To prepare & review the DMF as per the pharmacopeia & customer requirement. To Submit the DMF to the Regulatory Authority as per the Regulatory requirement. To prepare & review declaration as per customer vendor questionnaire requirement. To perform Nitrosamine risk assessment as per the guideline requirement. To perform Genotoxic risk assessment as per the guideline requirement.

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 and concemed departments about the same. 8. Keep up to date with a company's product range. 9. Ensure that a company's products comply with the current regulations. 10. Formulate strategy for all regulatory submissions. 11. Participate in regulatory and customer inspections, review audit reports and submit compliance report to regulatory agency. 12. Maintain approved applications in compliance with appropriate guidance 13. Identifling the tlpe of changes & submit them as per country guidelines (life cycle management). 14. Monitor progress of all registration submissions country-wise and product-wise.

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Any job assigned by immediate supervisor/HOD Preferred candidate profile Experience required - Pharma API background Perks and benefits As per industry

Global Calcium is looking for an experienced Manager - Regulatory Affairs with expertise in DMF & CEP filings and global regulatory submissions. If you have a passion for ensuring regulatory compliance and working with global health authorities, we want to hear from you! Key Responsibilities: DMF & CEP Filings: Prepare, review, and submit Drug Master Files (DMFs) in eCTD/NeeS format for USFDA, EU, and other markets. Handle amendments, annual updates, and regulatory deficiency responses. Regulatory Submissions & Compliance: Collaborate with R&D, Quality, and Manufacturing teams to compile technical data while ensuring adherence to GDP & global regulatory guidelines. Regulatory Communication & Strategy: Act as a liaison with regulatory authorities (USFDA, EU-GMP, TGA, etc.) and provide guidance on compliance strategies. Audits & Documentation: Support regulatory inspections & audits, ensure all regulatory documents are updated, and train internal teams on submission processes. Qualifications & Skills: Education: M.Pharm / B.Pharm / M.Sc. in Pharmaceutical Sciences, Regulatory Affairs, or Chemistry. Experience: 08+ years in Regulatory Affairs, with expertise in DMF & CEP filings. Key Skills: Regulatory guidelines, documentation, stakeholder management, analytical thinking, and communication skills. Why Join Us? Work in a globally recognized organization in the pharmaceutical industry. Contribute to key regulatory approvals across international markets. Collaborate with a team of experts in a dynamic environment. Interested candidates can send their resumes to: ramakrishnar.r@globalcalciumpharma.com Know someone who might be a great fit? Share this opportunity!

Department - Regulatory Affairs Designation - Sr. Officer No. Of Vacancy - 2 (1 Male/ 1 Female) Qualification - M.Pharm Required Experiance - 2 3 Years/2 5 Years Key Roles ( As per JD) Prepare Dossier According the Guidelines Co Ordinate & Communication with Business Development team regulatory Compliance Review all DMF, F&D, QC, Production & Packaging Department Documents and API Manufacture Documents for Prepare Dossier Checking and Approvals for Artwork for Different Countries including Contract Manufdacturing Prepare and submission of COPP, FSC and Product Permission in FDCA. Industry - Pharma(Injectables) Regards, Darshana cv.naukri@evokehr.com

Responsibilities: 1.Document Preparation: a) Assist in preparing and reviewing regulatory submission documents (e.g., CDSCO). b) Ensure accuracy and compliance with regulatory guidelines. 2.Filing and Submissions: a) Help coordinate and submit documents to regulatory bodies. b) Maintain detailed records of all regulatory submissions and approvals. 3.Compliance Support: a) Monitor product compliance with current regulations and standards. b) Help ensure documentation aligns with regulatory changes and updates. Comprehensive understanding of products and technologies Review the unique products and search the regulatory data of particular product. Develop and write clear arguments and explanations for new product licenses and license renewals Provide the strategic advice to senior management throughout the development of new product Take part in the development of marketing concepts and approve packaging and advertising before a products release Monitor and set timelines for licence variations and renewal approvals. Update/Report the everyday work to the Reporting Manager. Skills: Legal Knowledge Strong Writing and Documentation Decision-making Time Management Situational Analysis Preferred qualification: Bachelors degree (or equivalent) in a relevant discipline 2-3 year of experience

1. COA/ Certificate of Analysis 2. MSDS 3. Specifications/ TDS 4. Method of Analysis 5. Stability Data 6. DMF/ Drug Master File 7. Declarations B. Preparation of Vendor Questionnaire Required Candidate profile C. Customer response for technical queries D. Must have knowledge of Pharmacopoeias, ICH guidelines Intrested Candidate Can connect on 91-9724346949 / 9327657730

Oversee the preparation, review, and submission of regulatory filings, including DMFs, ANDAs CTD submissions, and other relevant documentation. Document review Preparation and submission of DMF to various countries. Review & verification of BPCRs , PVP/PVR and method validation reports. Regularly updating and maintaining regulatory work sheets for monthly management review. Review and compiling vendor Qualification Documents and ROS etc. Review and compiling of CMC documents. Gathering and reviewing documents received from QA and other departments. Compilation of technical Data Packages, Quality Overall Summary & Open Part DMFs. Preparing US DMFs for USFDA, ASMF, CEP etc. Preparing Customer query response to AP/OP DMfs & TDPs raised by various customers. Preparing Applicant Part/ Open Part DMFs to various Customers. Preparation of LOAs LOEs, others declarations & commitment based on customers.

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.

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of building regulatory dossiers of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.You will be expected to collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? Life Sciences Regulatory Services Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Agility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Master of Pharmacy

Academic Background and Experience: Academics - M.Sc. in Chemistry Experience 13 to 25 years Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills Role & responsibilities Review documents from various departments to compile regulatory submissions. Oversee Drug Master Files (DMFs) for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMFs to ensure regulatory compliance. Coordinate with cross-functional teams (CFT) to address deficiencies and feedback from regulatory authorities and customers. Conduct CFT meetings to ensure timely responses to regulatory deficiencies and customer inquiries. Provide regulatory guidance to product development teams and attend Technology Transfer Meetings to support compliance. Maintain and update regulatory databases, ensuring accuracy and completeness. Review and approve regulatory submissions and related documents prepared by team members for compliance. Manage change controls and other relevant documents, including approving them in the HOD's absence. Respond promptly to technical queries from regulatory bodies and customers. Interested candidates share their CV to dinesh.baratam@msnlabs.com Please mention subject line "API RA Manager/AGM profile"