331 Usfda Jobs - Page 10

Role & responsibilities Responsible for utilities, air conditioning, water system & maintenance of building & premises, maintenance of production, engineering equipments and QMS activities. To ensure the engineering activities such as preventive maintenance, routine & breakdown maintenance, calibration, Equipment & area validation are carried out as per the schedule. To ensure that all the subordinates are adequately trained for Job assigned. Optimum utilization of resources. To ensure that Optimum resources such as man, material & areas are available for the smooth operation of engineering related activities. To prepare Periodic assessment sheet on power and fuel and to Monitor and check the Power and fuel as per the approved Work Plan. To Monitor and control the Revenue Budget of Engineering Utilities. To Design, Plan and execute the Project activities at site. To ensure that all SOP’s related to engineering are being Followed. Validation & qualification of all equipment’s/system of utilities and air conditioning. To ensure that contactors are trained for the job they are doing. Preparation & revision of SOP’s related to engineering activities. Compliance to all type of Statutory requirements and all type of work of the Production Block and other premises. Design of Preventive Maintenance Plan of Electrical Equipment as per stipulations in IE Rules Interpretation of applicable legal requirements, Practices at Plants &Installations prone to Electrical Fires Construction, Installation, Protection, Operation and Maintenance Of Electrical System, Equipment’s, Instruments and Apparatus at Project sites in line with Section 29 Of IE Rules and conformance of all requisites as per Chapter IV of IE Rules Legal & other Requirements, Evaluation Of Legal and Other Requirements Preventive Maintenance of Electrical Equipment as per plan Safe Distribution and Utilization of Electrical Power and laying down and compliance of Loss Control Practices at all Operations and Storages Maintenance of Bulk Petroleum Storages as per Electrical Norms set forth in Petroleum Act. Calibration and Setting of Electrical Metering Equipment and Other Instruments to Support Management of Energy Uses in relevant Segments. Electrical Energy Management and Control. PDCA Approach and Loss Minimization Inspection of Own and Contractors Electrical Equipment i.e. ELCB,s / RCCB / Portable Equipment and Tools, Relays, Breakers, Welding Sets and Cables etc. Understanding, Implementation and Operational Training relevant for improvement in Energy Performance, Effective Maintenance of all Electrical Equipments/Accessories Ensure World class Electrical Energy Conservation Practices and Development of the same. Conduct Survey/Studies/EA for improvement of facility/Equipment Energy Budgeting, Monitoring, Control and Optimization Analysis of Electrical Breakdowns and promotion of Safe and Efficient Practices at all levels. Analysis of malfunctions which interrupt the operations Development of Inspection Protocol in Electrical System for Effective and Efficient energy performance Calibration Of Electrical Equipment / Instruments as per plan Ensure / Co-ordinate for Energy Audits and Inspection as and when planned for. Operation and Maintenance Of DG Sets, Noise Control of DG Sets, Efficient Operation of DG Sets. Legal Compliances Inspection and Audit Of Electrical Contractors based on established and controlled checklists. Understanding Risks in Electrical Systems and laying down control practices in line with regulatory provisions & Company requirements to establish, Maintain and Implement EnMS Ensure timely Electrical Audits by Inspectors, Internal Electrical Audits, Inspections and Reporting System adequacy and Objectives for Improvement. Training to team on applicable legal and other requirements regarding Maintenance and Operation of Electrical System and Apparatus Human Resource Development in Electrical Department. Provide Training Company Policy interpretation and objectives for improvement in Electrical O&M and Energy Conservation Process. Energy Performance Monitoring Of the Electrical Process, its Effectiveness, Gap Analysis. Preferred candidate profile Mandatory USFDA exposure is required

Role & responsibilities Responsible for utilities, air conditioning, water system & maintenance of building & premises, maintenance of production, engineering equipments and QMS activities. To ensure the engineering activities such as preventive maintenance, routine & breakdown maintenance, calibration, Equipment & area validation are carried out as per the schedule. To ensure that all the subordinates are adequately trained for Job assigned. Optimum utilization of resources. To ensure that Optimum resources such as man, material & areas are available for the smooth operation of engineering related activities. To prepare Periodic assessment sheet on power and fuel and to Monitor and check the Power and fuel as per the approved Work Plan. To Monitor and control the Revenue Budget of Engineering Utilities. To Design, Plan and execute the Project activities at site. To ensure that all SOP’s related to engineering are being Followed. Validation & qualification of all equipment’s/system of utilities and air conditioning. To ensure that contactors are trained for the job they are doing. Preparation & revision of SOP’s related to engineering activities. Compliance to all type of Statutory requirements and all type of work of the Production Block and other premises. Design of Preventive Maintenance Plan of Electrical Equipment as per stipulations in IE Rules Interpretation of applicable legal requirements, Practices at Plants &Installations prone to Electrical Fires Construction, Installation, Protection, Operation and Maintenance Of Electrical System, Equipment’s, Instruments and Apparatus at Project sites in line with Section 29 Of IE Rules and conformance of all requisites as per Chapter IV of IE Rules Legal & other Requirements, Evaluation Of Legal and Other Requirements Preventive Maintenance of Electrical Equipment as per plan Safe Distribution and Utilization of Electrical Power and laying down and compliance of Loss Control Practices at all Operations and Storages Maintenance of Bulk Petroleum Storages as per Electrical Norms set forth in Petroleum Act. Calibration and Setting of Electrical Metering Equipment and Other Instruments to Support Management of Energy Uses in relevant Segments. Electrical Energy Management and Control. PDCA Approach and Loss Minimization Inspection of Own and Contractors Electrical Equipment i.e. ELCB,s / RCCB / Portable Equipment and Tools, Relays, Breakers, Welding Sets and Cables etc. Understanding, Implementation and Operational Training relevant for improvement in Energy Performance, Effective Maintenance of all Electrical Equipments/Accessories Ensure World class Electrical Energy Conservation Practices and Development of the same. Conduct Survey/Studies/EA for improvement of facility/Equipment Energy Budgeting, Monitoring, Control and Optimization Analysis of Electrical Breakdowns and promotion of Safe and Efficient Practices at all levels. Analysis of malfunctions which interrupt the operations Development of Inspection Protocol in Electrical System for Effective and Efficient energy performance Calibration Of Electrical Equipment / Instruments as per plan Ensure / Co-ordinate for Energy Audits and Inspection as and when planned for. Operation and Maintenance Of DG Sets, Noise Control of DG Sets, Efficient Operation of DG Sets. Legal Compliances Inspection and Audit Of Electrical Contractors based on established and controlled checklists. Understanding Risks in Electrical Systems and laying down control practices in line with regulatory provisions & Company requirements to establish, Maintain and Implement EnMS Ensure timely Electrical Audits by Inspectors, Internal Electrical Audits, Inspections and Reporting System adequacy and Objectives for Improvement. Training to team on applicable legal and other requirements regarding Maintenance and Operation of Electrical System and Apparatus Human Resource Development in Electrical Department. Provide Training Company Policy interpretation and objectives for improvement in Electrical O&M and Energy Conservation Process. Energy Performance Monitoring Of the Electrical Process, its Effectiveness, Gap Analysis. Preferred candidate profile Mandatory USFDA exposure is required

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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.

Role & responsibilities 1. Shall responsible to review implementation & maintain of the Quality Management system with the regulations. 2. Determining, negotiating, and agreeing on in-house quality procedures, standards and specifications 3. Checking & Maintaining of Master Documents related to the QMS system. 4. Shall responsible to review filled Batch Production control record & analysis report for batch release. 5. Responsible for coordinate validation activity and validation protocols. 6. Responsible for control and approve deviations whenever raised in the concerned department and record the deviations. 7. Review and approval of the standard operating procedures for other concerned departments. 8. Responsible to plan and carry out internal audits & MRM. 9. Responsible for Coordinate with QC/Production for handling and investigation of Market complaints. 10. Responsible for conducting on-going training programs for new recruits and retraining for existing employees of concern department on the topic of SOP, GTP, GLP cGMP, WHO, ISO, etc. whenever required or as per schedule & Responsible for verifying the effectiveness of training programs system. 11. To check and approve artworks in coordination. 12. Verification and approval of the change control whenever the change in the document, facility, process, and equipment. 13. Verification and approval of documents concern to the production process, analysis including quality system. 14. Responsible for verifying the effectiveness of corrective action and preventive action systems. 15. Responsible to review & maintain system represent in QA department SOPs like OOS, OOT, (document record, storage & retention), Document control, APQR, Calibration, Trend data, etc. 16. Should have better co-ordination with QA, Production, QC, Engineering & Maintenance, for implementation of cGMP and also the electrical department. 17. Responsible for complying with all regulatory queries during any inspection and audit. 18. Responsible for application to FDA, FSSAI, Kosher, Halal, ISO, and others for any approval like Technical person, License/Renewal License, and additional Product, GMP. 19. Also responsible to work on time and to ensure TAT (Turn Around Time) given by Directors, any other job assigned by Superior. 20. Ensuring the manufacturing processes comply with standards at both the national and international levels. Job Type: Full-time

JD @ QC Executive will ensure that products meet quality standards & regulatory requirements with analyzing samples, conducting tests, maintaining documentation & more Accommodation, Meals & Transport from client side Saturdays are Half day

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.

Handling of all Vendor Management related activities including qualification of Vendors, Service Providers, Contract Manufacturing and Contract Testing Laboratories across R&D, API and Formulation units of Biological E, pharma divisions. To perform On-site audits as part of vendor audits, contract testing laboratories, contract manufacturing, external service vendors qualifications. Initiation and Review of Quality Management Systems (QMS), including Change controls, Deviations, Investigation reports and CAPAs. To perform Risk assessments related to Vendor, Contract Testing Laboratories and Contract Manufacturing and Service Provider qualification related activities. Preparation & review of Quality agreements & Technical agreements. To provide support / relevant information to the customers / suppliers as per the requirement and to provide remediation plans for the audit observations, if any To schedule, perform the self-inspections and review the Self-Inspection reports and relevant documents as applicable. To facilitate and review the performance of quality system through the review of QMS documents for Management Review Meetings. To co-ordinate for Management Review Meetings. To review and monitor the effectiveness of system changes and adequacy of CAPAs and post closure effectiveness checks. To track the health authorities observations at the Site and R&D and verify the compliance. To coordinate with the team for preparation and implementation of SOPs pertaining to Corporate Quality.

Hi Jobseeker, Greetings from Laurus Labs Ltd...! Please find the below Opening for Packing (OSD-Formulations) at Laurus Labs Ltd - Visakhapatnam. Department : Manufacturing- Packing Designation : Asst.General Manager Exp : 20-25 years Interested candidates can send their resume to Sarvani.gontu@lauruslabs.com and please send the below details for further process. Total Exp : Current CTC : Expected CTC : Notice Period : Regards, HR Team Laurus Labs Ltd

Prepare and submit regulatory documentation for new and existing products. Monitor and interpret global regulatory requirements relevant to physiotherapy and medical equipment. Maintain regulatory compliance throughout the product lifecycle. Interface with regulatory agencies, notified bodies and external consultants. Ensure accurate and timely product registrations in target markets. Maintain up-to-date Device Master Files (DMF) and Technical Documentation. Support clinical evaluation and risk assessment documentation where required. Ensure products comply with applicable regulations, standards and guidelines Manage change notifications, renewals, amendments and post-market surveillance requirements. Support A for audits, CAPAs, internal documentation practices and inspections from regulatory bodies. Provide regulatory guidance to R&D, QA, Marketing during product development and changes. Review and approve labeling, packaging and promotional materials to ensure compliance. Collaborate with external consultants, legal teams or distributors for country-specific compliance. Monitor regulatory changes and industry updates across markets. Participate in external seminars, forums and internal training to build regulatory awareness. Supporting and enabling effective and efficient communication that results in operational excellence. Skills required: Degree in Biomedical Engineering, Pharmacy or related field. 36 years of regulatory experience in the medical device industry. Strong knowledge of regulatory frameworks (US FDA, EU MDR, CDSCO, ISO 13485). Experience with regulatory submissions and product registrations. Excellent technical data interpretation skills including problem solving Excellent oral and written communication skills with strong presentation skills Demonstrate subject matter and area expertise Excellent computer skills; Good knowledge of document management systems Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Role & responsibilities Review and approve product test license, Import license for RLD and API. Review and approve standard operating procedures (SOPs) of equipment, instruments & facilities. Plan and execute reverse engineering of RLD and marketed products. Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products. Plan and optimize formulation for Injectable dosage forms. Compile, review and approve technical documents, including Formulation Development and Stability study protocol reports. Plan and perform stability studies to ensure formulation meets stability requirements. Compile, review and approve API, Formulation stability reports. Ensure compliance with regulatory documents and company quality standards. Coordinate with Analytical, Regulatory, Stores, Purchase, Project management and Development Quality Assurance teams to support product development and regulatory submissions. Maintain laboratory equipment and ensure proper calibration and maintenance. Participate in technology transfer activities to manufacturing sites. Prepare FD lab for agency audits and customer visits. Other roles and responsibilities assigned by the FD Manager and R&D Head. Preferred candidate profile Master's degree in Pharma or related field Must have 06 - 08 years of Experience in Formulation Development Must have 04 - 06 years of team handling role in R&D Centre

Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (No Objection Certificates) for imported pharmaceutical products. Regulatory Strategy: Provide strategic input on regulatory requirements for new product development, lifecycle management and post-market activities, including regulatory intelligence gathering and competitive landscape analysis. Cross Functional Collaboration: Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing teams to ensure alignment with regulatory strategies and compliance. Regulatory Health Authority Communication: Act as a liaison between the company and regulatory agencies to address questions or requests regarding regulatory fillings and approvals. Documentation and Reporting: Maintain accurate and up-to-date records of regulatory agencies submissions, communications with regulatory authorities and product approval status. Regulatory Training: Assist in training internal teams on regulatory requirements and best practices to ensure overall compliance across departments. Audit and Inspection Management: Coordinate with regulatory bodies in the event of audits, inspections or investigations. Preferred candidate profile Education: Bachelor's degree in Life Sciences (Pharmacy, Biology, Chemistry or related field). Advanced degrees (e.g. Master's or Ph.D.) are a plus. Experience: Minimum 05 -07 Years of experience in Regulatory Affairs, with a focus on regulatory submissions and drug licensing in the pharmaceutical industries. Knowledge: In-depth knowledge of regulatory requirements (FDA, EMA, ICH, etc.) drug development processes and regulatory submission strategies.

Walk In Drive For Quality Control Department In Formulation Division @ Bollaram Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 08-06-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:- MSNF-II , Kothur | MSNF-V, Rk Puram Venue Location:- Plot No- 42, Anrich Industrial Estate, Bollaram Village, Hyderabad, Telangana 502325 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Quality Control Formulation ( HPLC,GC,UV,Dissalution, LCMS, GCMS). 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 : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quality Audit and maintain the company anytime audit ready. Participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs & NCs. To monitor & handle market complaints. Conduct Management review at site. Conduct Calibration of instrument & Maintain Calibration Matrix . Ensure that a respective Change Control procedure is in place and adhered to . Process validation protocol preparation & implementation. Provide leadership and expertise on all aspects of product regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to regulatory compliance. Must be capable to handle all types of Audit. To Lead and face the regulatory audits and close all queries and NC in stipulated time. To maintain all documents related to compliances. Create Maintain & update Device Master/ Product Technical File. Preferred candidate profile: Graduate in Science or Engineering . Post Graduation preferred. Thorough Experience in quality and regulatory areas. Thorough experience in ISO 13485, GMP, US FDA, EU MDR, CDSCO, ISO 9001. Regulatory functions throughout the organization including monitoring , improvement , audits, and team building. Thoroughly conversant with technical documentation requirement and preparation. Excellent MS office skills. Should have faced multiple audits from multiple agencies Should have thorough knowledge of the applicable standards Perks and benefits: Medical Insurance for Spouse , 2 Kids Below 18 years upto Rs. 3lac.

Dossier Power House

Role & responsibilities :- Job overview :- The role requires strong analytical data review skills and experience with various QC instruments . The position involves supporting their North American sites , Potentially requiring the candidate to work according to US time zone. Key Responsibilities & Required Experience: Strong exposure to Analytical Data Review and electronic data review from QC instruments such as HPLC, GC, Dissolution Apparatus, and Malvern 3000 Thorough understanding of Quality Control investigations, including Lab Incidents, OOS, and OOT Preparation and Review of Method validation, Method Transfer, Method Verification and Equivalency documents, etc Review of Analytical raw data, Chromatography, and LIMS for Raw Materials/In-process/Finished Products. Preparation and Review of new SOPs. Candidates must have relevant experience in Oral Solid Dosage (OSD) formulations and/or Active Pharmaceutical Ingredient (API) processes. Kindly note the following: The selected candidate will support one of their sites in North America and will be required to work as per the US time zone . Strong communication skills are essential for this role.

Job Description: Extensive knowledge of ANDA & ANDS submission activities and post-approval procedures and related ICH, USFDA and Health Canada related guidelines. API DMF review with respect to complete USFDA regulatory requirement. Thorough knowledge of Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to assess the dynamic change cases with respect to ICH Quality / post approval USFDA guidance and Knowledge of Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Finalization of the Annual Report with required submission data as per USFDA guidance and ensuring its submission as per stipulated timeline. High quality review of entire submission package to avoid any major deficiencies for submitted supplements. Having knowledge about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames. Ensure to better management of major supplements submissions and approval process. Coordination with Cross Functional teams for the documents acceptance as per regulatory requirements. Ensure the no delay in submission always keen to adopt all regulatory submission requirements for complete submission. Maintain regulatory information as per current department practice. Having good Regulatory review and communication skills. Having good team management skills

Prepare, review, and file global premarket documents, collaborate with teams, develop regulatory strategies, and ensure compliance with India, US FDA, and EU regulations for medical devices or pharmaceuticals.

Responsibilities: * Prepare documentation according to ISO 13485 standards. * Ensure compliance with EU MDR, US FDA & CDSCO guidelines. * Maintain regulatory documentation * Internal Audits

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client Name: USA based Pharma Company Position: Executive - Regulatory Affairs (Formulations for USA market) Department: Regulatory Affairs Location: Ahmedabad Job Profile: Responsible for supporting the Regulatory Affairs department in its efforts to remain in compliance with the regulations of all intended market territories (USA Market). Regulatory support for assigned projects through product development and lifecycle management of products for US market. Review and approve labels in line with US regulatory requirements for assigned products. Prepare, develop, and maintain internal Regulatory informational trackers. Prepare technical documents required for submission of dossier as per country specific requirements. Respond to consumer inquiries based on approved labels and product information. Coordinate the receipt of raw material regulatory documents from vendors. Preparation of module 1 sections including labelling sections. Perform drug listing of assigned products for US market. Support publishing of ANDA submissions Support manufacturing site for commercialization and life cycle management of the approved products. Other projects and duties as assigned by Senior Management. Desired Profile: B.Sc / B.Pharm / M.Sc / M.Pharm with 2 to 5 years experience in US regulatory affairs Labelling department with growing & well established pharmaceuticals. OTC products Experience is a Plus. Must have good exposure in supporting role of ANDA filling for USA market. Exposure in Solid Oral (Tablets & Capsules) for regulated markets (USA) would be preferred. Exposure to working in US Markets is Mandatory. Ability to compile, manage and interpret data. Ability to work both independently and within a team environment. Ability to manage several tasks simultaneously. Ability to co-ordinate & manage the project with external stake holder. Effective communicator with excellent relationship building & interpersonal skills. Proficiency in Microsoft Office and Adobe Acrobat. Strong communication skills, both verbal and written. Strong organizational skills. Recruiter's Contact Details: BEST-FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India Mobile: 09722042906, 09722052906 E-Mail: post@bfrr.in Website: www.bestfitrecruitment.co.in

Job Title: Senior Regulatory Publishing Specialist Responsibilities:Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets.eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch.Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks. Manufacturing Document Review: Review critical manufacturing documents such as MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol, and PDR.Response to Agency's Queries: Prepare and review responses to regulatory agencies' queries, ensuring timely submission within stipulated deadlines.Regulatory Submissions Development: Develop and deliver comprehensive regulatory submissions within agreed-upon timeframes, providing crucial regulatory support to project teams for assigned projects. Qualifications:Education: Bachelor's/Master's Degree (preferably in B Pharm/ M Pharm) or Any Life Science field. Experience: Minimum 3-6 years of hands-on experience within the CRO/Biotech/Biopharma industry. Expertise: Demonstrated expertise in gap analysis, publishing, and knowledge of CTD compilation.Communication Skills: Excellent communication and interpersonal skills, both written and spoken, with the ability to effectively interact with sponsors and internal stakeholders at all levels. Location - Madhapur, Hyderabad, Telangana, India 500081

Key Responsibilities: Search and review scientific information / literature Drafting, submitting applications with all necessary information to RA for related Licenses required for Product Development. Identify and propose formulation strategy for product development. Read, discuss and plan Developmental activities, bring Innovation in work and adopting Digital Initiatives while doing scientific work. Visualize the developmental needs of the product. Work along with Cross functional team towards to meet project milestones as per timelines. Use Scientific approach to mitigate challenges during development, scale up and Technology transfer of the product. Qualification M.Pharm/Phd(Pharmaceutics): Experience- 2-6 years Additional Information

Roles and Responsibilities Prepare dossiers for DMF (Dossier Management Facility) submissions to US FDA, including eCTD structure preparation, data compilation, and review. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Review and compile technical documentation for various global markets, ensuring compliance with regulations. Manage change controls, variation applications, renewals, variations, extensions, and post-approval changes. Provide guidance on regulatory requirements to internal stakeholders. Desired Candidate Profile 6-10 years of experience in Regulatory Affairs or related field (API industry preferred). MS/M.Sc(Science) in Chemistry or equivalent qualification. Strong understanding of emerging markets' regulations (US FDA). Excellent communication skills with ability to work effectively across functions.

QC - Planning of samples for analysis as per schedule and requirements, Qualification and maintenance of laboratory standards required during analysis, Verification of raw data, work sheets, log books.

Off Targets is a leader in pharmaceutical innovation, committed to developing advanced therapeutic solutions that address unmet medical needs. We are looking for an experienced and dynamic professional to lead our Formulation Development department, driving the development of cutting-edge injectable drug products. Job Description We are seeking an accomplished R&D leader to head our Injectable Formulation Development function. The ideal candidate will bring deep technical expertise in complex injectable products and a strategic mindset aligned with 505(b)(2) development, regulatory planning, and IP differentiation. Key Responsibilities: Lead end-to-end formulation development of complex injectable drug products (liposomes, emulsions, depot injections, suspensions, etc.). Design and drive a robust R&D pipeline focused on 505(b)(2) opportunities . Provide strategic input into USFDA regulatory planning (CMC sections, QbD, stability). Contribute to patent strategy and product differentiation from early development. Collaborate with analytical, regulatory, IP, and business development functions. Mentor a high-performing R&D team and build scientific leadership. Solve scale-up and technology transfer challenges. Maintain strong compliance with global quality and documentation standards. Key Skills: Injectable Formulation, 505(b)(2), Liposomes, Emulsions, Depot Injections, Formulation R&D, CMC, USFDA, Drug Delivery, Intellectual Property, Team Leadership, Innovation Strategy Desired Candidate Profile: Qualification: Ph.D. / M.Pharm in Pharmaceutics or related field Experience: 15+ years in pharmaceutical R&D with at least 5 years in a strategic leadership role Proven expertise in injectable formulations and 505(b)(2) development Strong knowledge of USFDA CMC expectations, IP evaluation , and regulatory submission processes Excellent leadership, innovation, and cross-functional collaboration skills Perks and benefits Opportunity to lead a key department in a forward-thinking pharmaceutical company. A collaborative and supportive work environment that encourages professional growth and innovation. Competitive salary and benefits package, with opportunities for advancement. Access to state-of-the-art facilities and cutting-edge technology. How to Apply: Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to business@offtargets.com