98 Dmf Jobs - Page 3

Ideal candidate will prepare error-free DMF submissions to regulatory authorities. Manage amendments and annual reports, address regulatory queries, ensure compliance in development/validation, assess impurities. Required Candidate profile Please apply only if your qualifications match the requirements.

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About Team The Statutory Audit Team is responsible for ensuring the accuracy and compliance of our company's financial statements with relevant laws and regulations. This team conducts thorough audits to identify areas of improvement, mitigate risks, and provide assurance on the financial health of the organization. With expertise in financial reporting, auditing standards, and regulatory requirements, the Statutory Audit Team plays a critical role in the system. About the role: 1. Oversee and manage the general accounting functions, including, but not limited toaccounts payable, accounts receivable, general ledger, and taxes 2. Help with quarterly and year-end financial audit activities and the annual corporate financial controls audit 3. Assess current practices and procedures, and make recommendations for improvements 4. Prepare, review, and analyze financial statements to ensure accuracy and completeness 5. Perform ad hoc analysis and projects as requested 6. Supervise and/or manage general ledger accounting functions 7. Develop staff by managing performance, setting goals, providing ongoing training, and maintaining strong employee relationships 8. Work with auditors to ensure correct and timely closing and reporting at year-end Expectations/ : 1. Creative and dedicated individual who will fit with our collaborative culture 2. Cohesively work with a lot of people, across functions and teams every day 3. Coordinate with other departments for compatibility of all aspects of each project 4. Develop comprehensive project plans along with key stakeholders 5. Program manage initiatives that are driven centrally for Technology improvements 6. Track Program/Project performance, specifically to analyze the successful completion of short- and long-term goals 7. Engage with various Business & Technology Teams within Paytm to identify common bottlenecks esp. on Technology front 8. Enable and encourage use of common services to increase the speed of development and execution 9. Smart thinking and clear communication 10. Use and continually develop leadership skills Superpowers/ Skills that will help you succeed in this role: 1. 2 to 4 years of progressive accounting experience, with a portion of it being in a supervisory role 2. Thorough knowledge of Ind AS GAAP 3. Excellent verbal and written communication abilities across all level of an organization 4. Strong leadership skills with a dedication to driving and achieving results 5. Knowledge of employee relationship building and performance management techniques 6. Advanced Microsoft Excel skills. Experience with other financial systems. Education Chartered Accountant. Why join us: 1. A collaborative output driven program that brings cohesiveness across businesses through technology 2. Improve the average revenue per use by increasing the cross-sell opportunities 3. A solid 360 feedbacks from your peer teams on your support of their goals 4. Compensation: If you are the right fit, we believe in creating wealth for you With enviable 500 mn+ registered users, 21 mn+ merchants and depth of data in our ecosystem, we are in a unique position to democratize credit for deserving consumers & merchants – and we are committed to it. India’s largest digital lending story is brewing here. It’s your opportunity to be a part of the story!

Must have knowledge of documentation (COA, MSDS, VQ Filings , APQR, MOA,DMF) COA/ Certificate of Analysis • MSDS • Specifications/ TDS • Method of Analysis • Stability Data • DMF/ Drug Master File • Declarations Required Candidate profile Intrested Candidate Can share your CV in Whatsapp : 91-9724346949 / 9327657730

Designation : Executive / Sr Executive Department : Regulatory Affairs (API Industry only ) Qualification :M.Sc in Chemistry. Experience: 3 to 6 years. CTC : Rs 5 lacs to 7 lacs. Key Skills: DMF, NDA / ANDA dossiers, Regulatory Affairs. Filing of new Drug Master Files (DMFs) / Dossiers to respective countries (US, Europe, EDQM, Japan ) by compiling the documents as per CTD requirements. To interact and coordinate with R&T and manufacturing sites for all regulatory submissions (New filing and Amendments) and customer requirements. Maintaining life cycle of products as per the respective region wise requirements. Submission of Applicant Part to customers as per the requirement. Candidates working in formulations may skip this job post.

•Direct the preparation and submission of regulatory agency applications, reports, or correspondence. •Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Required Candidate profile Experience in Regulatory Affairs function with experience in preparing DMF for US / EU / Japan / ROW market and handling their queries / deficiencies.

Follow daily shift activates without deviations Follow daily operations and logbooks updation as per SOP Please coordinate with MAC and calibration activity with internal team WTP snatization activates as per schedule

Sodexo Food Solutions India Pvt. Ltd. is looking for Operator - Stp Wtp to join our dynamic team and embark on a rewarding career journey Responsible for coordinating all work requests coming in through e mail, phone or any other form of communication regarding the services provided to the client by Sodexo Key Responsibilities Collaborate with other members of the Sodexo on site team, to dispatch as well as collect the work orders established after receiving a request through mail/phone/paper. Collect all closed work orders to close the calls. Produce reports based on the data collected, through produced work orders, for Sodexho and the Client Receive and answer all incoming calls/mails/papers reporting complaints or work requests Log in the call through the software, which in term generates work orders Set up reports with all collected data coming from the work orders for the Client as well as for Sodexo for controlling, transparency and information purposes Maintain the helpdesk work area and equipment in a clean and orderly condition following all prescribed regulations Maintain the confidentiality and security of all data and information relating to the facility Maintain professional appearance at all times

Sodexo Food Solutions India Pvt. Ltd. is looking for Operator - Stp Wtp to join our dynamic team and embark on a rewarding career journey Responsible for coordinating all work requests coming in through e mail, phone or any other form of communication regarding the services provided to the client by Sodexo Key Responsibilities Collaborate with other members of the Sodexo on site team, to dispatch as well as collect the work orders established after receiving a request through mail/phone/paper. Collect all closed work orders to close the calls. Produce reports based on the data collected, through produced work orders, for Sodexho and the Client Receive and answer all incoming calls/mails/papers reporting complaints or work requests Log in the call through the software, which in term generates work orders Set up reports with all collected data coming from the work orders for the Client as well as for Sodexo for controlling, transparency and information purposes Maintain the helpdesk work area and equipment in a clean and orderly condition following all prescribed regulations Maintain the confidentiality and security of all data and information relating to the facility Maintain professional appearance at all times

Role & responsibilities - Preparing Dossiers for registration of products in various ROW markets - Knowledge of CTD format is mandatory Preferred profile Qualification: B. Pharm and M. Pharm Experience: 2 years Salary: 20,000 to 40,000 per month Health insurance Accidental insurance Annual bonus

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled with experience in process validation and variation submissions. Your responsibilities will extend to maintaining robust electronic document management systems (EDMS) and ensuring manufacturing records align with regulatory requirements. This position demands a proactive individual with excellent communication skills to effectively liaise with regulatory agencies and internal stakeholders, ensuring Synnat Pharma maintains its commitment to quality and compliance in the pharmaceutical industry. Job Details: Industry: Pharmaceutical (API Division) Department: Regulatory Affairs Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 5,00,000 - 10,00,000 INR per annum Experience: 5-9 years Qualification: Bachelor's degree in Pharmacy, Chemistry, or related field Responsibilities: R egulatory Submissions & Documentation: Prepare, review, and submit comprehensive regulatory dossiers and technical documentation for API products to various health authorities (US FDA, EMA, CDSCO). Manage the compilation, archiving, and tracking of all regulatory documentation using electronic document management systems (EDMS). Ensure all regulatory submissions are accurate, complete, and compliant with current regulatory guidelines and requirements. Maintain up-to-date knowledge of changes in pharmaceutical regulations and guidelines and communicate these changes to relevant stakeholders. Prepare and manage Drug Master File (DMF) filings, renewals, and updates, ensuring timely submissions and compliance. Coordinate with cross-functional teams (manufacturing, quality control, R&D) to gather necessary data and documentation. Regulatory Compliance & Inspections: Lead and manage regulatory inspections conducted by health authorities, ensuring preparedness and compliance. Develop and implement corrective and preventive actions (CAPA) in response to inspection findings and regulatory queries. Conduct internal audits to ensure compliance with pharmaceutical regulations and quality standards related to API manufacturing. Review manufacturing records and analytical data to ensure compliance with regulatory requirements and guidelines. Monitor and ensure adherence to pharmacopeias (USP, EP, BP) and ICH guidelines in API manufacturing processes. Maintain a thorough understanding of API manufacturing regulatory compliance. Regulatory Communication & Liaison: Act as the primary point of contact for communication with regulatory agencies regarding submissions, queries, and inspections. Prepare and manage responses to regulatory queries and deficiency letters, ensuring timely and accurate information. Liaise with internal stakeholders to address regulatory issues and provide guidance on compliance matters. Communicate regulatory updates and changes to relevant departments. Cultivate and maintain positive relationships with regulatory agencies. Provide support and guidance to cross-functional teams on regulatory expectations. Variation & Renewal Management Prepare and submit variation applications for changes to approved API manufacturing processes and formulations. Manage the renewal process for existing regulatory approvals, ensuring timely submissions and compliance. Assess the impact of proposed changes on regulatory filings and ensure appropriate documentation is prepared. Track the status of variation and renewal applications and communicate updates to stakeholders. Ensure all variations and renewals align with current regulatory guidelines. Maintain a comprehensive record of all variations and renewals submitted General Expectations and Past Experiences: Possess a Bachelor's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrated experience (6-9 years) in regulatory affairs within the pharmaceutical industry, specifically in API manufacturing. Proven expertise in preparing and managing DMF filings and regulatory submissions for global health authorities (US FDA, EMA, CDSCO). Strong knowledge of pharmaceutical regulations, ICH guidelines, and pharmacopeias (USP, EP, BP). Experienced in regulatory inspections and responding to regulatory queries and deficiency letters. Proficient in EDMS and other relevant documentation systems. Excellent communication, interpersonal, and problem-solving skills with the ability to work cross-functionally.

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About Team The Statutory Audit Team is responsible for ensuring the accuracy and compliance of our company's financial statements with relevant laws and regulations. This team conducts thorough audits to identify areas of improvement, mitigate risks, and provide assurance on the financial health of the organization. With expertise in financial reporting, auditing standards, and regulatory requirements, the Statutory Audit Team plays a critical role in the system. About the role: 1. Oversee and manage the general accounting functions, including, but not limited toaccounts payable, accounts receivable, general ledger, and taxes 2. Help with quarterly and year-end financial audit activities and the annual corporate financial controls audit 3. Assess current practices and procedures, and make recommendations for improvements 4. Prepare, review, and analyze financial statements to ensure accuracy and completeness 5. Perform ad hoc analysis and projects as requested 6. Supervise and/or manage general ledger accounting functions 7. Develop staff by managing performance, setting goals, providing ongoing training, and maintaining strong employee relationships 8. Work with auditors to ensure correct and timely closing and reporting at year-end Expectations/ : 1. Creative and dedicated individual who will fit with our collaborative culture 2. Cohesively work with a lot of people, across functions and teams every day 3. Coordinate with other departments for compatibility of all aspects of each project 4. Develop comprehensive project plans along with key stakeholders 5. Program manage initiatives that are driven centrally for Technology improvements 6. Track Program/Project performance, specifically to analyze the successful completion of short- and long-term goals 7. Engage with various Business & Technology Teams within Paytm to identify common bottlenecks esp. on Technology front 8. Enable and encourage use of common services to increase the speed of development and execution 9. Smart thinking and clear communication 10. Use and continually develop leadership skills Superpowers/ Skills that will help you succeed in this role: 1. 2 to 4 years of progressive accounting experience, with a portion of it being in a supervisory role 2. Thorough knowledge of Ind AS GAAP 3. Excellent verbal and written communication abilities across all level of an organization 4. Strong leadership skills with a dedication to driving and achieving results 5. Knowledge of employee relationship building and performance management techniques 6. Advanced Microsoft Excel skills. Experience with other financial systems. Education Chartered Accountant. Why join us: 1. A collaborative output driven program that brings cohesiveness across businesses through technology 2. Improve the average revenue per use by increasing the cross-sell opportunities 3. A solid 360 feedbacks from your peer teams on your support of their goals 4. Respect, that is earned, not demanded from your peers and manager Compensation: If you are the right fit, we believe in creating wealth for you With enviable 500 mn+ registered users, 21 mn+ merchants and depth of data in our ecosystem, we are in a unique position to democratize credit for deserving consumers & merchants – and we are committed to it. India’s largest digital lending story is brewing here. It’s your opportunity to be a part of the story!

Prepare and submit regulatory documents for product approvals, renewals, variations, and notifications. Maintain up-to-date knowledge of regulatory guidelines. Dossier preparation. Support product registration processes. Required Candidate profile 1–3 years of experience in regulatory affairs. Qualification : BSC / MSC / B Pharm Office Location : Mulund

Preparation and Compilation of DMF's in-line with regulations of Regulatory and Semi-Regulatory countries. Supporting to the concerned Marketing department/team's in terms of providing appropriate documents. Coordinating effectively with all cross functional teams (QC, QA, R&D, and Production) to procure the documents and to develop the documents required for compilation of API DMFs. Attending calls/Meetings with marketing teams, customers and plants regarding regulatory related issues as and when required. Development of DMF's for registration of products in countries like Brazil, China, Russia markets. Collecting, collating and evaluating scientific data received from plant/R&D. Responsible for timely planning, coordination and submission of API DMF's/deficiencies in EMT markets. Review of documents and compilation, identifying gaps, ensure suitability, acceptance etc. Guidance to cross-functional teams and team members on EMT regulatory strategy and regional regulatory requirements. Timely quality response to external customers on technical queries and requests. Life Cycle management of the products. Maintain compliance with the regulatory requirements.

Regulatory Strategy & Planning Submissions & Approvals Team Leadership & Governance Global Compliance & Maintenance Cross-Functional Collaboration External Stakeholder Management

1. Preparation and review of Drug Master Files, Dossiers as per regulatory guidelines. 2. Ensuring compliance with regulations set by the authorities. 3. Keeping up to date with changes in regulatory legislation and guidelines. 4. Analyzing complicated information & data provided by other departments, including trial data. 5. Ensuring that quality standards are met and submissions meet strict timelines. 6. Coordination with QA, QC & R&D to get documentation required for preparation of Drug Master Files & Technical dossiers. 7. Responsible for DMF/Dossier updations, revisions. 8. Responding to Customers and Regulatory Authorities on technical queries in time. 9. Maintaining customer correspondences.

Role & responsibilities Regulatory Strategies & Submissions: Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs. Preparing and submitting regulatory documents like Drug Master Files (DMFs) and marketing authorization applications (MAAs) to regulatory bodies. Preparation and Compilation of dossiers in CTD & eCTD. Collaborating with cross-functional teams to address regulatory queries in a timely manner. Responsible for end-to-end filing of New products (Actives / Fixed Dose Combinations / Nutritional supplements etc.) in CDSCO (Central Drugs Standard Control Organization), FSSAI, State FDA and other regulatory bodies. Filing application of ND/SND/FDC/Import Registration/Import license etc. on SUGAM portal. Track and interpret evolving regulatory requirements and assess their impact on ongoing projects. Collaborate with marketing and business development to support go-to-market strategies, portfolio expansion. Compliance & Change Control: Ensuring that manufacturing processes meet all relevant regulations and guidelines. Assessing and managing the regulatory impact of changes to manufacturing processes. Review of technical documents, Change controls Gap analysis for variation filing and maintaining product Life cycle. Collaborating with cross-functional teams, such as R&D, QA, and manufacturing, to ensure regulatory compliance. Audits and Inspections: Preparing for and supporting regulatory audits and inspections across various contract manufacturing sites. Ensuring that corrective actions are implemented in a timely manner with respect to Audit findings and that any necessary documentation is updated in a systematic manner. Others: Staying up-to-date with current FDA / FSAAI regulatory requirements and guidelines for APIs and Finished formulations. Provide regulatory support to QA-AC for IPC/CDTL/CDL testing Providing regulatory support for new product development. Key Result Areas: Manage proactive and professional delivery of results for the regulatory activities of all the products to support the business goals Ensure a high scientific standard and quality for all regulatory documents Monitoring and ensuring that both API manufacturing and Finished formulations production adhere to all applicable regulations. Preferred candidate profile B-Pharma or M-Pharma Minimum of 8 to10 years of experience in regulatory affairs in pharmaceutical industry, With at least 3 to 4 years in a managerial role. Strong understanding of pharma regulatory framework. Excellent communication and multi-tasking skills Location Mumbai HO / Regular visits to various Contract Manufacturing sites Department Regulatory Affairs

Urgent Requirement For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 13 to 23 years of experience in FML Regulatory Affairs Job Title: Deputy Manager / Manager / Senior Manager / AGM Experience: 13 to 23 years in FML RA field Candidates Only. Education: B Pharm \ MSc \ M Pharm Department : Regulatory Affairs - FML Markets : China, Europe, Australia, US, ROW Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills Role & responsibilities International Product filing Registrations and life-cycle management Expertise in Regulatory Norms for regulated markets / emerging market. dossiers, renewal & variation applications for various markets based on CTD, ACTD and/or other region-specific requirements. Respond to queries raised by regulatory agencies and/or local partners of the above regions. Review and give regulatory feedback on technical documents like process validation, AMV, Stability and composition, labeling, batch records, specification or test methods, etc. Ensure accuracy and compliance of documentation. Artwork recommendations and approvals as per regulatory provisions. Well-versed in ICH guidelines, maintain awareness of legislation and current developments in regulatory affairs Cross-Functional Team Work Represent regulatory affairs at cross functional meetings and coordinate with R&D, Production, Plant QA/QC and Marketing to efficiently and successfully complete regulatory activities Support plant teams in regulatory audits, liaison with domestic & export regulatory authority. Assess and approve change controls and update files accordingly . Interested candidates share their CV to narasimharaju.manthena@msnlabs.com

We are hiring for multiple roles in the QC Department! Join us at Global Calcium Pvt. Ltd. a leading pharmaceutical manufacturer, and be part of a growing team committed to quality and innovation. Open Positions (Multiple Vacancies): QC ICP-MS Analyst (2 openings) Hands-on experience with ICP-MS instrumentation Knowledge of elemental impurity analysis and related regulatory guidelines QC – DMF Support (2 openings) Exposure to DMF preparation, review & support documents Understanding of regulatory documentation and compliance standards QC – Analytical Validation Support (2 openings) Knowledge of method validation techniques (HPLC/GC/UV) Experience in handling validation protocols and reports QC – Wet Analysis (2 openings) Proficient in classical wet chemistry techniques Experience in raw material and finished product testing Eligibility Criteria: B.Sc / M.Sc in Chemistry or related fields 1 to 4 years of relevant pharmaceutical QC experience Good understanding of cGMP practices and regulatory compliance Willingness to work in a fast-paced manufacturing environment Walk-in Interview Details: Venue: Global Calcium Pvt. Ltd., Unit III, 19 & 19B, Sipcot industrial complex, Phase - 1, Dharga, Hosur Date: 14th June 2025 Time: 9:30 AM to 11:00 AM Documents to Carry: Resume, Recent Photograph, Last 3 Months' Payslips, Educational & Experience Certificates, ID Proof Note: Only candidates with relevant experience in the pharmaceutical QC domain will be considered. Role & responsibilities

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.

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms 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.

Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6. Responding to queries with in the time lines received from client/agency. 7. Preparation of check list as per country specific requirements in RoW region. 8. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in RoW region. 9. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. 10. Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. 11. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. 12. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Desired Candidate Profile Should Have Regulatory Affairs Relevant Experience Perks and Benefits

Role & responsibilities We are hiring for the role of Executive - Regulatory Affairs department (API Industry ) Preferred candidate profile Candidate with 3 to 6 years experience in the Regulatory Affairs (API Industry) can apply for the job . Please drop relevant cvs to ramya_n@hikal.com

Dossier Power House

Urgent job opening for Senior Quality Assurance Executive at Dombivli. Qualification : B.Sc., M.Sc. Experience : 6 to 8 years Description of Job Responsibilities 1) Responsible for Preparation and review of master documents of QA department and review of all master documents and formats of respective departments other than QA. 2) Responsible for review of technical documents such as Technology Transfer, MPCR, BPCR, Specification and Standard test procedure, stability data, etc. 3) Responsible for preparation of training schedule and provide training on QA-related topics, guidelines, regulatory and cGMP requirements to all concerned employees. 4) To evaluate Quality and stability of finished APIs. 5) Responsible for organizing and execution of internal audit program, review of observations, follow ups and closures. 6) To investigate & approve Deviations, Out of Specification 7) Responsible for preparation, review of MSDS and approval 8) Responsible for preparation, review & approval of annual product quality review. 9) Responsible for providing effective CAPA procedures, tracking completion and implementation of the same. 10) Responsible for validation activities as per validation master plan 11) Responsible to investigate & approve customer complaints and provide responses to customers regarding complaints. 12) Ensure handling, effectiveness and continuous improvement of the QMS System. 13) Initiates Follow-Up Audit activities in order to verify Audits and record the implementation and effectiveness of the Corrections & Corrective Actions 14) To organize & performed vendor audits for critical raw materials/ packing materials & testing labs. 15) Initiates Follow-Up Audit activities in order to verify Audits and record the implementation and effectiveness of the Corrections & Corrective Actions 16) Responsible for updating and maintaining Quality management system documents 17) To ensure that the preparation, submission of Drug Master Files to customers/ authorities 18) To ensure that responsible & provide the audit compliances, DMF query responses, market complaints/ queries related to documents or products 19) To organize and participate in MRMs and to monitor actions of the same 20) Responsible for procedures of approval/rejection/release/dispatch for commercial batches and documents. 21) Responsible for the preparation DMF (Close & Open part), replying to the QA / RA related queries of Marketing, Exports, Customers, Regulatory authorities & all work related to Regulatory Affairs (RA) functions. 22) Responsible for maintaining and handling of vendor qualification activities. If you are interested for the above referred position, kindly revert back with your Updated Resume with Photograph along with following details: 1) Current salary 2) Expected salary 3) Notice period 4) Total experience 5) Relevant experience 6) Current location 7) Reason for job change Contact no.:- Sakshi - 8591939527 Mail ID:- sakshi@jobsearchindia.in

Role & responsibilities Responsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries. Review and submission of Response to queries raised on DMF by USFDA, and other agencies. Review and submission of Amendments and revisions of Drug Master Files. Review and ensuring the regulatory compliance of CMC information and manufacturing facilities of advanced intermediated through regular visits, which are intended to submit to regulatory markets. Evaluation of cost reductions processes in regulatory point of view and submitting to different regulatory agencies. Review of OOS, BPR, process validation, and other quality assurance documents required for regulatory submissions. Markets Handled: USA, Europe, Canada, Brazil, other ROW etc. Preferred Candidate Candidate must have experience working in Regulatory Affairs in Pharma API Industry.