321 Injectables Jobs - Page 9

Supriya life science ltd is looking for Research Scientist - FRD (Injectable) to join our dynamic team and embark on a rewarding career journey. Research Planning : Develop and design research projects, experiments, and studies to investigate specific scientific questions or problems. Create detailed research plans, including methodologies, timelines, and resource requirements. Data Collection and Analysis : Perform experiments, gather data, and conduct data analysis using various scientific methods, statistical techniques, and specialized equipment. Interpret and evaluate the results to draw meaningful conclusions. Literature Review : Stay up - to - date with relevant scientific literature and research developments in the field. Analyze existing research to identify gaps and opportunities for further investigation. Hypothesis Testing : Formulate hypotheses and test them through experimentation. Analyze the outcomes to validate or invalidate the hypotheses. Innovation and Problem Solving : Utilize critical thinking and creativity to devise new approaches to scientific challenges. Propose and develop innovative solutions to complex problems. Collaboration : Collaborate with interdisciplinary teams, researchers, engineers, and other stakeholders to exchange knowledge, ideas, and expertise. Participate in discussions and contribute to group projects. Presentation and Communication : Present research findings to both technical and non - technical audiences through reports, presentations, scientific papers, and conferences. Effectively communicate complex scientific concepts in a clear and concise manner. Safety and Compliance : Adhere to safety protocols and ethical guidelines in conducting experiments and handling hazardous materials. Ensure compliance with all relevant regulations and institutional policies. Equipment Maintenance : Maintain and troubleshoot laboratory equipment to ensure accuracy and reliability in research activities.

To lead a team of Medical Representatives and guide them to meet doctors Nursing Homes / Hospitals & promote Critical Care Products. If interested, plz call at: 7742408300/ 7742408200 / 9999190672. mail at: lksaddiassociate@yahoo.co.in. Required Candidate profile ASM should have experience in Pharmaceuticals with a proven successful track record of min 1 to 3 Years as manager in Critical Care Segment at Hyderabad and adjoining areas. Perks and benefits Salary will not be constraint for right candidate.

Should have Knowledge of Documents. Should able to handle skilled/unskilled Labour. Should have knowledge of GMP/GDP Practice & aseptic behaviour. We are looking for pharma background candidate only. Perks and benefits PF Bonus Food

We are seeking a dynamic and experienced candidate to lead and manage the overall operations of our sterile injectable manufacturing plant. The ideal candidate will be responsible for ensuring seamless plant operations, regulatory compliance, quality standards, and people management while driving productivity and efficiency. About the Responsibilities Strategic Leadership: Lead the end-to-end operations of the sterile injectable plant, including production, quality, engineering, supply chain, and EHS functions. Regulatory Compliance: Ensure full compliance with internal and external regulatory standards (e.g., EU-GMP, WHO-GMP) and corporate SOPs. Operational Excellence: Drive continuous improvement in manufacturing efficiency, cost optimization, and product quality. Oversee the implementation of digitalisation, such as optical inspection and serialisation. People Management: Build and lead a high-performing cross-functional team. Foster a culture of accountability, safety, and innovation. Project Execution: Oversee capacity expansion, technology transfer, and commissioning of new lines (e.g., lyophilization, isolator-based filling systems). Stakeholder Engagement: Collaborate with corporate leadership, regulatory bodies, and cross-functional teams to align plant goals with organizational objectives.

Process Maintenance Management Ensure the proper operation and maintenance of equipment used in the production of vaccines and injectable, including sterile systems, filling lines, and aseptic processing equipment. Develop and implement preventive maintenance programs that adhere to GMP standards to minimize downtime and ensure continuous production. Manage maintenance activities for critical production and utility systems, including HVAC, autoclaves, sterilization systems, and other aseptic equipment. Lead troubleshooting efforts for any process or equipment failures, ensuring prompt corrective actions are taken while complying with safety and regulatory standards. Instrumentation and Control Systems Supervise the installation, calibration, and ongoing maintenance of all instrumentation and control systems in the plant, including those that monitor and control critical manufacturing parameters. Ensure compliance with GMP, FDA, and other regulatory standards for instrumentation used in the production of vaccines and injectables. Collaborate with quality assurance (QA) and validation teams to validate control systems and instrumentation for accuracy, reliability, and compliance with regulatory requirements. Lead troubleshooting and maintenance activities for any failures in instrumentation, ensuring immediate corrective action and minimal impact on production. Water Systems Management Oversee the operation, maintenance, and monitoring of water systems, including water for injection (WFI) systems, ensuring that they meet the required pharmaceutical-grade quality and regulatory standards. Ensure compliance with regulatory requirements for water quality, including microbial control and endotoxin levels. Manage water treatment and distribution systems, coordinating routine cleaning, sanitization, and validation of these systems. Ensure water systems are maintained to prevent contamination and safeguard product quality. Utility Systems Management Manage and maintain critical utility systems, including steam, compressed air, HVAC, and cooling systems, ensuring they meet stringent pharmaceutical manufacturing standards. Implement and maintain energy efficiency and sustainability practices, in line with regulatory standards and corporate sustainability goals. Oversee the maintenance and calibration of systems used in temperature and humidity control, which are critical for sterile production environments. Regulatory Compliance & WHO Audits Lead preparation for WHO audits, FDA inspections, and other regulatory audits, ensuring all maintenance practices, systems, and equipment are fully compliant with GMP and regulatory requirements. Ensure the engineering and maintenance documentation, including calibration logs, preventive maintenance records, and validation documents, are accurately maintained and ready for audit. Collaborate with the QA team to support the resolution of audit findings and the implementation of corrective actions. Stay up to date on the latest regulatory changes and industry standards, ensuring the plant operates in full compliance at all times. Validation and Qualification Oversee the qualification and validation of critical equipment, systems, and processes to ensure they meet all required regulatory and operational standards. Work closely with the validation team to develop, execute, and maintain qualification protocols for equipment, systems, and utilities. Ensure that all maintenance activities are aligned with the requirements of the validation master plan (VMP) and that any changes are appropriately documented and validated.

Job Summary: We are seeking a Regulatory Affairs Specialist with 4 to 8 years of experience in compiling, preparing, and submitting regulatory dossiers in accordance with European regulations (EMA/EU). The ideal candidate will have a proven background in injectable drug products and will ensure regulatory compliance throughout the product lifecycle, working closely with cross-functional teams and regulatory agencies. Key Responsibilities: Prepare, compile, and review regulatory submissions for the EU region, including CTA, MAA, Variations, Renewals, and PSURs/DSURs. Ensure dossiers comply with EMA and national regulatory authority requirements, including eCTD/NeeS formatting. Maintain product registrations and ensure timely submission of updates, renewals, and amendments. Liaise with internal departments (e.g., R&D, Quality, Clinical) to collect and verify data for regulatory submissions. Respond to queries from European regulatory agencies and prepare responses to deficiency letters. Monitor changes in EU regulatory requirements and assess the impact on products and documentation. Contribute to regulatory strategy development during all phases of the product lifecycle. Manage electronic submission tools and regulatory databases. Assist in audits and inspections to support compliance with regulatory expectations. Required Qualifications: Bachelors or Masters degree in Pharmacy, Life Sciences, or a related field. 4–8 years of hands-on experience in EU regulatory dossier preparation and submissions. Experience in regulatory submissions specifically for injectable drug products is mandatory. Strong knowledge of EMA guidelines, EU regulations (including 2001/83/EC and 2017/745 for medical devices if applicable). Experience with eCTD software and publishing tools. Understanding of regulatory procedures: CP, DCP, MRP, and national submissions. Excellent written and verbal communication skills. Strong project management and organizational abilities. Preferred Skills: Experience in a CRO, pharmaceutical, or medical device company. Knowledge of regulatory requirements beyond the EU (e.g., UK MHRA, Swissmedic). Experience with regulatory intelligence tools and databases.

Role & responsibilities Lead Pre Formulation studies for solid orals, oral liquids, external preparations, injectable products, and nutraceuticals. Design project strategies through comprehensive literature surveys. Conduct API and excipient characterization, drug and excipient ratio studies, and explore various manufacturing strategies. Develop and finalize QQ formulas in alignment with the requirements of the Business Development (BD) team. Coordinate with BD team to ensure timely project execution. Finalize specifications for finished products. Evaluate product stability during manufacturing, monitor stabilized batches, and prepare related reports. Enhance existing formulations and explore new dosage forms possibilities. Procure innovator products, conduct comparative characterization studies, and test products. Prepare product development reports (PDRs), identify critical material attributes (CMAs), critical process parameters (CPPs), and critical quality attributes (CQAs) for robust product development using Quality by Design (QbD) principles. Execute development studies and prepare comprehensive study reports. Optimize formulations and processes using QbD methodologies. Respond to queries related to commercial and under development products promptly. Ensure effective technology transfer of F&D products. Review and authorize documents related to stability, inuse stability, forced degradation, and Bioequivalence (BABE) protocols. Authorize formulation related activities for BABE projects and lead BABE projects as required. Perform any other tasks assigned by the Head of Department (HOD) or management. Preferred candidate profile Pharma industries only Formulation THANKS YOU REGARDS MILAP RATHOD (74868 29377) whtup HR DEPARTMENT OPES HEALTHCARE PRIVATE LIMITED

Role & responsibilities • You will be responsible for documentation and execution of qualification activities. This includes preparation, review and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ and (Requirement Qualification) documents. • Your responsibilities include review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems. • You will be responsible for new project related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). • You will review and compile raw data, relevant certificates, analysis test reports and • preparation and review of final summary report. • You will be responsible for preparation and review of protocols and reports for media fill validation and cleaning validation. • Your role involves initiation of relevant CRN (Change Request Number) for new or existing activity, timely closure of assigned action plans as per CRN, and CRN review and approval. • You will be responsible for corrective and Preventive Action (CAPA) implementation and handling of incident investigations and CAPA related to qualification. • As part of your role, you will prepare and review VMP (Validation Master Plan). • You will conduct training for employees and external vendors as a qualified trainer. • Your role includes preparation and review of qualification SOPs (Standard Operating Procedure), conducting investigations as a site investigation team member, and updating Qualification status label. • You will be responsible for periodic qualification schedule preparation, updating and execution, and qualification of new or transferred equipment. • You will also provide necessary assistance and support to various regulatory, internal and external inspections.

To offer consultation & patient diagnosis at Kaya Skin Clinics, perform/supervise all medical procedures to be carried out in clinic, ensuring efficacy, safety & high professional standards of medical procedures carried out under your supervision. Required Candidate profile Presentable & Good Communication Candidate must be MBBS along with MD or DVD or DDV or DNB Perks and benefits Leaves & Incentives as per company policy

Role & responsibilities Identify and onboard new CMO clients for injectable manufacturing To work for tech transfer, out licensing, search CMO for developing company Developed Products for commercialization, and to find suitable marketing partner for selling company product into Regulated Markets partnering with potential and suitable Marketing Partners Manage and grow relationships with domestic & international partners Work cross-functionally with operations, QA, RA, and supply chain teams for smooth project execution Develop and execute a roadmap to achieve 100 crore business potential Serve as the key customer contact point and ensure complete client satisfaction and compliance Preferred candidate profile Education : B .Pharm / M.Pharm with strong academic credentials Experience : 8 to 10 years in the pharmaceutical industry, with proven track record in CMO/Third-Party Manufacturing Prior experience in handling injectables and CMO operations across India and Global Markets is essential Excellent business development , client relationship , and coordination skills Capable of leading customer interactions, technical evaluations, price & negotiations, and end-to-end support formalities Must possess solid communication , negotiation , & project execution skills

QUALIFICATIONS Education: Advanced degree in Life Sciences, Pharmacy, or related field Experience: 15+ years in regulatory affairs, including 5+ years leading global teams in biopharmaceuticals. Proven track record in NDAs/BLAs for novel therapies (ophthalmology/metabolic disorders preferred). Expertise in FDA/EMA interactions, including Pre-NDA meetings and Advisory Committees. Skills: Proficiency in clinical trial design, statistical analysis, and regulatory writing. Familiarity with eQMS tools (Veeva, TrackWise) and regulatory intelligence platforms. Global Regulatory Strategy & Submissions Develop and execute regulatory strategies for novel biologics, including pre-IND meetings, orphan drug designations, and accelerated approvals. Lead NDA/MAA submissions for US FDA, EMA, and other agencies, ensuring compliance with ICH guidelines and regional requirements. Oversee clinical trial applications (CTAs/INDs) and provide input on study design, endpoints, and risk mitigation. Team Leadership & Cross-Functional Collaboration Manage a global team of regulatory professionals, fostering expertise in biologics, ophthalmology, and metabolic disorders. Partner with R&D, Clinical Development, and CMC teams to align regulatory plans with development milestones. Compliance & Audit Management Ensure adherence to GCP, GMP, and 21 CFR Part 11 standards during regulatory inspections and audits. Maintain submission timelines using eCTD formats and electronic submission gateways Team & Project Management Mentor QA leaders across sites, fostering a culture of quality and accountability. Design training programs on GMP/GLP updates, inspection readiness, and root cause analysis methodologies. Post-Marketing & Lifecycle Management Direct post-approval regulatory activities, including variations, renewals, and safety updates. Monitor evolving regulations (e.g., FDAs Novel Drug Approvals guidance) and implement proactive compliance measures.

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD – Manufacturing / QMS (Senior Officer / Officer / Executive) Experience - 02 to 07 Years Qualification – B. Pharmacy/ M Pharmacy Engineering (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification – BE / B Tech Time and Venue : 14th June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

For Production : Exposure pertaining to groninger vial filling , groninger bottle filling, fedegari autoclave, NKP vial filling machine, lyophilizer , spray dryer , aseptic process, complex manufacturing, exposure to CIP/SIP, skid manufacturing, pre filling syringe , QMS is required. Experience required is 2-6 yrs. For Engineering : Should to preventive/ breakdowns maintenance of sterile manufacturing plant, maintenance of autoclave, filling machine - vial, bottle, ampoule, ophthalmic, lyophilizer, freeze dryer machine , BFS machine is required. Experience required is 2- 6 yrs. Job Location : Sun Pharmaceutical Medicare Limited : Nr. Hotel Sarvottam, Survey NO 22 & 24 , Village : Ujeti , Post :Baska , Tal: Halol : 389350 Dist. Panchmahal, Gujarat, INDIA. Mb No : 02676 610 603 / 628

Responsibilities: Responsible for formulation and process development of Injectable dosage forms. Troubleshoot and problem-solve unresolved or new formula issues. Design and execute formulation trials to finalize formulation composition. Provident fund

Role & responsibilities Aurobindo Pharma Ltd. Unit IV (Naidupeta, Tirupati Dist., Andhra Pradesh) Open Functions: Quality Assurance (Market Complaints / QMS / Validation / IPQA) Quality Control (GMP / GC / LCMS / HPLC) 3 Experience Required: 2 7 years (pharmaceutical manufacturing) Job Titles & Grades: Executive / Sr. Executive (based on experience) Job Description: Quality Assurance Key Scope • Handle Market Complaint investigations, trend analysis and regulatory responses • Maintain site QMS: Deviations, CAPA, Change Control, Audit readiness • Execute and review Equipment / Process / Cleaning Validation documentation • Perform IPQA activities: line clearance, in-process checks, batch record review • Conduct GMP & Data-Integrity training for shop-floor teams Quality Control Key Scope • Routine & stability testing of RM / IP / FP samples on HPLC, GC, LCMS, UV, etc. • Prepare/standardise analytical methods, calibration & instrument qualification (IQ/OQ/PQ) • Adhere to GDP, ALCOA+ and cGMP guidelines; ensure timely LIMS/SAP data entry • Investigate OOS/OOT results and implement effective CAPA • Support regulatory, customer and internal audits Common Requirements: • Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Chemistry or related) • Sound knowledge of current GMP guidelines (US-FDA, MHRA, EU, WHO) • Good documentation, investigation and communication skills • Willingness to work in shifts and collaborate with cross-functional teams How to Apply • Send you updated resume : naidupetahr@aurobindo.com • WhatsApp : 9851444337

Walk In Interview Interview Day & Date : 14-06-2025 (Saturday) Time : 08:00 to 11:00 Am Department : Production Sciences or Pharmacy Graduates (M.Sc. / B. Pharm. / M. Pharm.) with 0 to 6 years Experiences in parenteral manufacturing (vial / ampoules / bottles of glass or Plastic through BFS technology). Candidate worked in production compliances / remediation / and having experiences of managing quality system document (CCN / CAPA / investigation etc.) ACULIFE HEALTHCARE PRIVATE LIMITED. Formally known as nirlife Near Railway Crossing (Sanand - Viramgam Highway) Village: Sachana, Taluka : Viramgam District: Ahmedabad 382 150

Role & Responsibilities Responsible for analytical method validation (AMV), Analytical method transfers (AMT), Analytical method equivalencies (AME) for injectable projects with tests such as Assay, Related substances, Content estimation, Molecular weight determination, CCIT, PSD, Cleaning validation etc. Responsible for Analytical method development, feasibility studies for injectable products tests such as Assay, related substances, preservative content, molecular weight, cleaning method and reverse engineering for product elucidation as and when required. Preparation of Test data sheets, Protocols and Reports for AMV, AMT and AME studies. Perform query related activity for injectable projects. Review of pre-validation data prior to start of Analytical method validations. Preparation of analytical method development reports, documentation in LNB, TDS/LIMS, as applicable as per GLP/GMP compliance. Responsible for interpretation of analytical data and communicating the same to concern groups & individuals. Responsible for operation & calibration of various Analytical instruments. Ensure applicable SOPs training during routine working. Responsible for day-to-day analytical laboratories activities. Responsible for maintaining work area as per safety guideline. Responsible for verifying availability of pre-requisites of validation with respect to individual projects. Responsible for completion of calibrations and monthly flushing of systems within stipulated timelines. Ensure compliance to all cGMP, GLP or any other regulatory requirements, including EH&S requirements. Ensure integrity of data generated during routine working and to follow ALCOA principles.

Biological E. Limited invites dynamic & self-motivated fresher candidates for Production department at its Pharma SGI - Injectables USFDA Approved plant, Shamirpet, Hyderabad: Desired Candidate Requirements: Good communication skills Able to work in shift operations (A,B & C) ITI & B.Sc & Diploma & B.Pharmacy passed in 2024 & 2025 with > 60% marks Learning apatite Confidence Prepared male candidates

Medicamen Biotech - SRL Pharma R&D Centre Required Formulations Profile Designation: Executive/ Scientist Qualifications: M. Pharma - Pharmaceutics Vacant Post: 6 Nos. Experience: 4 to 8 Years Please share profile on uday@shivalikrasayan.com Required Candidate profile Pharma R&D experience must in Formulation USFDA exposer prefer Preparation of Pharmaceutical Development Report Ready to relocate Bhiwadi, Rajasthan Ready to join Immediately Prefer Team Player Perks and benefits Best of Industries Salary based on Experience

To offer consultation & patient diagnosis, perform/supervise all medical procedures of Dermat Led services ensuring efficacy, safety & high professional standards of medical procedures carried out under your supervision. Required Candidate profile Consultation & Patient Diagnosis Perform doctor led services Candidate must be MD or DVD or DDV or DNB in Dermatology Lucrative incentive will also be given CONTACT-Ishan/Neetu 9910796268/7838473883 Perks and benefits Leaves & Incentives as per company policy

Requirements: 1-3 years of experience in Injectable Plant production. Expertise in sterile manufacturing. Strong understanding of regulatory compliance & quality standards Educational qualification in Pharmacy, Biotechnology, or related fields.

Role & responsibilities To achieve the targets set by the management. Build up a motivated team. To ensure total market coverage, target achievement and information flow from the team to management. Continuously handle the challenges of the market keeping the HO/ ZH/ Client informed. Data / knowledge management. Create + implement a strategy to grow the region. Vacancy management and attrition control. Team performance monitoring, review & management. Compilation of stock and sales statements. Succession Planning. Preferred candidate profile Lead generation to conversion through account management / hospital business. Ensure sales effectiveness by delivering call average and coverage. Maintain a high level of professionalism in handling customers. Execute marketing strategies like Promotion Campaigns / CMEs / Patient Experience Programs etc. to enhance Brand Image & Brand Recall. To carry out marketing research related to new product/market feasibility & also to ascertain the feedback on existing / new services launched. Monitoring competitor activities and business in the assigned territory and timely report the findings. Create a strategic road map for every account (Corporate Hospital) and Health care professional. Report customer feedback/complaints on our services to the clinical team through the proper channel. Daily reporting of the field visits & activity details to the respective line manager, planning work schedules, regularly attending company meetings, presentations, and briefings to consistently achieve the monthly and annual targets assigned. Minimum Qualification : Science graduate- B.Sc. / B.PHARMA / BE/ B.Tech Experience : 3 yrs+ experience as ABM in good healthcare company or 1-2 yrs exp as a RBM in a healthcare company. Age : Up to 40 yrs. Fitness- Candidate should be Physically & Mentally Fit with no communicable disease. Should be ready for medical checkup if required. Basic Knowledge : Computer XLS / Word/ Internet Communication skill - Fluency in English is required Knowledge of his/her current working domain is mandatory Benefits: (all as per applicable Indian Govt Statutory norms) Applicable TA/DA as per field working reimbursement policy for the position. Performance based incentives as per applicable policy for the position. Cell phone/ Internet reimbursement Health insurance/ Life insurance Leave encashment. Paid sick time/ Paid time off. Provident Fund, etc. Willingness to travel: 100% (Preferred)

Should have minimum 2-6 years of experience in IPQA (Injectable) or Analytical QA (OSD/Injectable)

Walk In Drive For Quality Control Department In Formulation Division @ Corporate Office Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Skills :- HPLC | GC | Dissolution | IP/FP | Stability (OSD & Injectables) | USFDA | Regulatory approvals Division :- Formulation Interview Date:- 15-06-2025 (Sunday) Interview Time :- 9.00AM TO 2.00PM Work Location:- MSN Formulation Unit II, Kothur & MSN Formulations Unit- V, RK Puram Venue Location:- MSN Corporate, H. No. 2-91/10 & 11 /MSN, Whitefield's, Kondapur, 5000845 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

Role & responsibilities: Compilation and review of registration dossiers as per Country specific guidelines and requirements. Specific experience required for Latam American market including Brazil, Mexico. Should have to work for EU market and hands on experience about the submission Management system. Review of all Technical Documents (DMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.) Compilation of deficiency responses of new product submission and Backlog dossier To review the proposal for any post-approval changes as per the current regulatory guidance. To prepare and submit the variation for post approval changes. To communicate and follow up with overseas regulatory team /agent/ distributors to ensure timely filing of new submission or variation. To review various artworks & comments for ongoing commercial supply & products for the new launch. To prepare and maintain various registration Data base & updating at Central Depository. Preferred candidate profile: Candidate must have core International Regulatory Affairs experience in Latam and EU market can only apply. Candidate should have good technical job knowledge of EU and other regulatory. Should have good communication and interpersonal skills