200 Usfda Jobs - Page 4

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Senior Research Scientist ADL Job Requisitions No : 12504 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Senior Research Scientist R&D ADL Job Requisitions No : 12705 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Senior Executive Regulatory Affaris Job Requisitions No : 13246 Job Description Purpose of Job The purpose of the job is to take the responsibility of Dossier requests received from internal business partners, Skill Required Experience of handling registrations of biosimilars in regulated and semi regulated markets, Experience of drafting dossier sections Experience of drafting query responses Experience of interactions and co-ordination with CFTs Strong communication skills Experience of handling RA tools Roles and Responsibilites Summary Of Job Functions Responsible for preparation of regulatory submissions (regulated and semi regulated markets) Key Responsibilities Responsible for authoring IMPD and MAA by collating all the documents for registration of biosimilar products in regulated market EU/US/ROW regions Preparation of scientific advice and briefing book documents for biosimilars Preparation of responses to queries received from various regulatory agencies To work within regulatory teams for effective preparation of CMC documents for regulated and semi regulated markets, Updating and maintaining the regulatory trackers with the required details Provide necessary regulatory assessment for change controls Qualification Required Pharm/B Biological experience is added advantage/preferable Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Senior Product Executive Neovet Job Requisitions No : 13015 Job Description Purpose of Job Manage poultry nutritional portfolio, responsible for identifying market opportunities, conducting market research, and working closely with cross-functional teams to develop and launch new products, Analyze market potential for the existing and new products and prepare forecasts for review meetings and presentations, Prepare print, audiovisual and infographic technical detailers, Provide technical support to the customer (provide feed formulation, conduct feedmill audits) Provides product training to sales staff To solve customer queries and complaints related to products Skill Required Knowledge of poultry nutrition and helth Knowledge of poultry feed formulation Brand management skill Public speaking for conduction seminars MS Word and PowerPoint presentations Roles and Responsibilites Managing product lifecycle, Designing and implementing marketing strategies, Designing and implementing marketing campaigns, Preparing product brochures and technical inputs, Conducting market research and launching new products, Technical support to customers and field staff Qualification Required Master of Veterinary Science in Animal Nutrition ( MVSC in Animal Nutrition) Relevant Skills / Industry Experience Animal nutrition Feed formulation PMT Technical services Location: Ahmedabad, GJ, IN, 380054 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Research Associate BDL Job Requisitions No : 13267 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Research Associate ADL Job Requisitions No : 12908 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationBangalore, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitting regulatory applications such as permits, licenses, certificates and authorization required by governmental agencies Coordinating government interactions and compliance activities; and interacts with regulatory agencies What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Support the RTB team lead in protecting DB from legal, regulatory and reputational risk with regard to business involving sanctioned entities and / or countries. Ensure diligent review and confirmation of transactions that require escalation to a Level 2 investigator and decide on these in full compliance with the applicable Sanctions regulations and the banks policies and procedures. Execute internal control checks as defined in the KOP documentation and Embargo control framework documents governed by AFC Sanction & Embargo. Support any applicable reporting obligations to the competent authorities with respect to transaction handling. Convert timely the update of the relevant embargo lists in respective filtering systems implement the data to central and decentralized tools in GT and Operations. Support CoC Regulatory Filtering team on the adoption of new clients Your Key Accountabilities RTB focus Primarily review stopped messages and take a decision on them (either pass or investigate), based on limited set of rules provided and maintained by AFC. Record rationale for decision from pre-defined set of options. Seek feedback from more senior investigators/reviewers, where their decisions fail the four-eye control. Provide support feedback loop and filter optimization by identifying repeat mismatches to propose Good Guys. Use user access privileges only for authorised purposes; actively safeguard sensitive and confidential information. CTB focus Supports TSMO / AFC related change projects Supports remediation actions owned by TSMO / AFC Training & Development Participate Trainings such as on HotScan, Sanctions policies, L1 procedures, specific payment types, including structure / form of messages. Your skills and experience Sanctions and Regulatory Filtering SWIFT Message Format and Fields SWIFT Payment Flow SEPA Message Structure and Payment Flow MS Office (MS Excel, Word and Outlook) Proficient in e mail communication Good communication skills (Written & Verbal) Ability to support rotational shifts Ready to support on weekends How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Carry out the manufacturing operations according to the BPCR provided by QA department Perform the Operations in accordance to the established SOPs and cGMP. To maintain for Good documentation practice .To execute Production planning schedule. Required Candidate profile < Qualification : B.sc /M.sc(Chemistry)/B. Pharmacy/B. Tech ( Chem engg) - Any chemistry Background. < Having Pharma Experience of 2- 8 Years of experience. Perks and benefits Free Bus , Canteen, Pf

Role & responsibilities You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company. Key Deliverables: 1. Ensure manufacturing practices as per cGMP and GLP standards. 2. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc. 3. Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.) 4. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits. 5. Ensure all personnel are trained on requirements for GMP, GLP, GDP, applicable regulatory issues and other procedures related to their work area. (SBG) 6. Evaluation and approval of Suppliers for RM, PM, testing labs and service providers. 7. Assisting HOD in customer complaint analysis and preparation of customer complaint report. 8. Investigation of incidents, deviations, OOS and ensure corrective actions in place. 9. Reviewing the daily availability of operators and allocating work to them. 10. Maintaining and review BMR documents, guide for relevant changes if required. 11. Label artwork review and management. Technical Competencies: a) Analytical skills (spotting trends and patterns) b) Report writing skills c) Problem solving abilities d) GMP and GDP knowledge e) Good English communication skills (verbal & written). Behavioural Competencies: a) Quality and Service Orientation b) Delivering consistent results c) Ability to prioritize, organize, manage work and time. d) Customer Centric e) Cross Functional Team Working Preferred candidate profile B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology) 8+ Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries. Perks and benefits 1. Opportunity to be part of a growing organization offering niche products to Pharma industry. 2. Opportunity to work at Head Office location. 3. Intimate small company culture with MNC professionalism. 4. Company value programs TrANSSCEnD. 5. Employee events like festival celebrations, family fun events etc. 6. Five days working (alternate weeks). 7. Medical Insurance for your immediate family. 8. Housing accommodation for Bachelors & family.

Vibonum Technologies Private Limted conducting a Walk-in interview for Production Supervisors and Production Officer for its OSD Plant at Mysore. Production Supervisor: Total Vacancies - 40, Education: B. Pharm / M. Pharm Exp: 5 Years and above Production Officer Total Vacancies - 40, Education: Diploma / ITI Exp: 5 Years and above Work Location: Nanjangud Mysore Walking Address: Sai Vishram Business Hotel, Hebbagodi, 144-C/1, Kirloskar Road, opp. MTR, Bommasandra Industrial Area, Bommasandra, Bengaluru, Karnataka 560099 Google Map: https://maps.app.goo.gl/Pkh8ASL1JFpJv2An8

Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline; 10+ years of professional experience in medical device regulatory affairs EU MDR, US FDA 510(k) and closely working R&D, Quality organizations. Strong proven experience creating Technical Documentation and 510(k) preparation and receiving submission approval (EU, Canada, US, etc.). Expertise in interpreting and implementing various medical device standards and guidance's, such as IEC 60601-1, ISO 14971-1, IEC 62366-1, ISO10993-1, and MEDDEV 2.7/4. Experience with systems for quality management, product development, and follow-up of procedures is an advantage. Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.)

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? contract conversion Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Role & Responsibilities Assist in API/intermediate manufacturing as per SOPs. Monitor production processes and ensure GMP & quality compliance. Maintain batch records, logbooks, and related documentation. Handle raw materials, samples, and finished goods safely. Operate equipment such as reactors, centrifuges, dryers, and filters under supervision. Collaborate with QA, QC, and Engineering teams. Maintain workplace hygiene and follow EHS guidelines Preferred Candidate Profile B.Sc. / M.Sc. in Chemistry or related discipline. 04 years of experience in API or intermediate manufacturing (Freshers can apply). Willing to work in rotational shifts. Good knowledge of GMP, safety protocols, and documentation practices. Strong attention to detail, willingness to learn, and teamwork attitude.

TASEC Limited is looking for Executive / Senior Executive - Quality to join our dynamic team and embark on a rewarding career journey. Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

Role & responsibilities 1. Product Strategy & Lifecycle Management: Develop and implement strategic product roadmaps for OSD products in alignment with business objectives. Conduct market research and competitive analysis to identify trends, opportunities, and threats. Manage the product lifecycle from development to commercialization, ensuring alignment with customer and regulatory requirements. 2. Business Development & Customer Engagement: Collaborate with the sales and business development teams to identify and engage potential clients. Support contract negotiations, pricing strategies, and proposals for new business opportunities. Serve as the key point of contact for clients, addressing their technical and commercial inquiries. 3. Project & Cross-functional Coordination: Work closely with R&D, manufacturing, regulatory affairs, and quality assurance teams to ensure seamless product development and commercialization. Drive project timelines and ensure deliverables are met within budget and compliance parameters. Facilitate internal and external stakeholder communication to optimize project execution. 4. Regulatory & Compliance Oversight: Ensure all OSD products comply with global regulatory requirements (FDA, EMA, MHRA, etc.). Stay updated on evolving regulatory landscapes and provide guidance to internal teams and clients. Support dossier development and regulatory submissions for product approvals. 5. Financial & Performance Metrics: Monitor product performance, profitability, and cost-effectiveness. Track KPIs and generate reports on sales, market trends, and operational efficiency. Identify opportunities for cost optimization and revenue growth. Preferred candidate profile Bachelors or Masters degree in Pharmacy, Life Sciences, Chemistry, or a related field. MBA is a plus. 6+ years of experience in product management, business development, or project management within a CDMO, pharmaceutical, or OSD manufacturing environment. Strong understanding of formulation development, tech transfer, and regulatory requirements for OSD products. Skills & Competencies: Strong analytical and strategic thinking skills. Excellent communication, negotiation, and stakeholder management abilities. Proficiency in project management tools and CRM systems. Ability to work in a fast-paced, matrix organization and manage multiple projects simultaneously. Knowledge of global pharmaceutical markets, trends, and competitive landscapes

Role & responsibilities Regulatory Affairs Associate I Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established “CLIENT”procedures and regulatory requirements Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches Be the interface with health authority (HA) and their systems for designated regulatory tasks e.g., management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA portals Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, certificates of pharmaceutical products, legal documentation, e.g., letters of authorisation, power of attorney, translations of regulatory documentation Provide support across the group for assigned non-drug project roles & responsibilities e.g., function as a designated point of contact or superuser Provide guidance and knowledge sharing within the RAM skill group If required, support in activities such as scheduling of regulatory submissions, PBRERs, etc. Minimum Requirements – Education and Experience Relevant qualification and/or experience in science Minimum 2 years of experience from biopharmaceutical industry, or other relevant experience Proficient verbal and written English Project management skills Experience in document management and tracking databases Preferred Experience Some regulatory/medical/technical experience Knowledge of “CLIENT”business and processes Some knowledge of “CLIENT”submissions, compilation, publishing and approval processes, standards, systems and tools Experience of collaborating with people from locations outside of India, especially Europe and/or USA Skills and Capabilities Good written and verbal communication skills in English Cultural awareness Proficiency with common document management tools Ability to work independently and as part of a team Focus on continuous improvement and knowledge sharing Internal and External Contacts/Customers Lead RPM and members of the Global Regulatory Execution Team (GRET) and Global Regulatory Strategy Team (GRST) Other R&D skill groups, e.g., GRO, Operations Regulatory, Patient Safety, Reg TA (GRL & Regional Leads) Marketing companies Health authorities External collaboration partners “client” Legal “CLIENT”vendors for translation, document authentication, etc. Reporting Relationship Direct Reports – None Indirect Reports – None Interested candidate may reach @ 9845914559 or drop your updated resume to below mail id Nithya_kumar@persolkelly.com Regards, Nithya CONFIDENTIAL NOTE: By submitting your resume or personal data, you acknowledge reading and agreeing to our Privacy Policy. You hereby provide voluntary consent to the collection, use, processing, and disclosure of your data by us and our affiliates, in line with the Privacy Policy. and applicable laws. If you wish to withdraw your consent or have any concerns, you may submit a request to our designated consent manager, as outlined in our Privacy Policy. We prioritize your privacy. SECURITY NOTE: We at PERSOLKELLY India or our representatives, do not ask job seekers for fees, personal banking information, or payments through unofficial channels. Official communications will only come from @persolkelly.com. Report any suspicious activity to Contactus_in@persolkelly.com. Click here to find out how you can safeguard yourself from job scams

Job Description: Executive- Regulatory Affairs- ANDA -(US Market) Responsible for ANDA Submission Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions. Provide regulatory expertise to scientists and senior management on new product development, and assist with the preparation and submission of regulatory documentation Support the maintenance of regulatory files. Strong knowledge of dossier preparation, compilation, and submission guidelines for various regions including Markets. Experience working on ANDAs, CTDs, injectables, Orals and other regulated products. If interested Kindly share your updated CV on khyati@bvrpc.com

Accountabilities Act as a resource on regulatory matters with regard to product changes. Collaborate to prepare and organize forums and gatherings with government officials to exchange ideas and information on business activities and potential legislation that may affect the organization. Help ensure that the organizations interests are represented and protected in legislative proceedings and in the development of market rules and procedures. Participate as part of a team to develop and maintain policies and programs to ensure awareness of government legislation and regulatory issues that affect the organization. Independently solve moderately complex issues with minimal supervision, while escalating more complex issues to appropriate staff. Other duties as assigned Qualifications Minimum Qualifications Bachelors degree in a related field or equivalent experience Minimum requirement of 3 years of relevant work experience with Public offices liaising in the Government departments of Andhra Pradesh. Preferred Qualifications Overall 7-12 years experience in a Govt Liaising role Certification in public law and proven experience of working on approvals, legislations in forums with Government officials in a manufacturing environment . Willingness to be based in a manufacturing site at Krishnapatnam Previous experience of working in close coordination with plant officials on Government related issues of the plant .

Position : Regulatory Affairs Executive Department : Regulatory Affairs Location : Ahmedabad Key Responsibilities Write, analyze, and edit technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. eCTD Compilation Annual Report Writing for USFDA Product Transfer Support Maintain regulatory files. Maintain and update regulatory authorizations. Assure that appropriate maintenance of registrations occurs including renewals, listings, site registrations, supplements for changes (PAC) and annual reports. Support approval in other regions as required. Assist in preparing response to regulatory authoritys questions within assigned timelines. Stay abreast of regulatory procedures and changes in regulatory climate. Review and create product labels and review promotional material for compliance with applicable regulations and technical standards. Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance. Other duties as assigned. Qualifications & experience required B. Pharm or M. Pharm / Graduate degree in life science background. Note: Immediate Joiners will be preferred.

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 requirement is matching your current job profile, kindly walk-in with your latest resume. Role & responsibilities Injectable - Manufacturing & Packing & Visual Inspection (Senior Executive / Executive / Senior Officer / Officer / Associate) Experience - 01 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI with relevant functional experience in injectable manufacturing/ Aseptic area operations / Packing / Visual inspection / QMS activities OSD Manufacturing ( Executive / Senior Officer / Officer / Associate) Experience - 01 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / Diploma with relevant functional experience in OSD manufacturing and Packing operations / QMS activities Time and Venue : 05th April 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. Preferred candidate profile *Having relevant qualification as mentioned above can attend the scheduled walk-in. Perks and benefits

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

Prepare and compile Drug Master Files (DMFs) for China in compliance with regulatory guidelines. Conduct thorough reviews of technical and regulatory documentation to ensure accuracy and compliance. Prepare and submit responses to deficiency letters (DL) from regulatory authorities. Manage the entire regulatory life cycle of API products, including updates, renewals, and variations. Work closely with internal teams (R&D, Quality, Manufacturing) and external regulatory agencies to ensure smooth approvals and compliance. Maintain up-to-date knowledge of global regulatory requirements and ensure adherence to the latest guidelines. 5-10 years of experience in Regulatory Affairs (API) with hands-on expertise in China DMF compilation, review, and submission Strong understanding of global regulatory guidelines, especially China requirements. Ability to analyze and interpret regulatory requirements with precision. Excellent written and verbal communication to effectively interact with regulatory authorities and internal stakeholders. Proactive approach to identifying regulatory challenges and developing solutions. Note: Candidates may be considered for positions in Regulatory Affairs specializing in Active Pharmaceutical Ingredients (API) with an interest in working in Emerging Markets (ROW) .

Role & responsibilities 1.Ensure proper documentation and fulfillment of statutory requirements with regards to various FDA authorities. 2. Collect information from various departments and prepare DMFs, Dossiers, amendments and supplements etc 3. Submit them to the pertinent regulatory authorities within a specified time frame to get approval. 4. Respond to queries as they arise and ensue that regishation/approvals are $anted without delay. 5. Coordinate customer and reeulatorv audits. 6. Provide compliance to customer complaints by coordination with marketing department. 7. Keep up to date of national and intemational legislations, guidelines (available on websites) and customer practices and concemed departments about the same. 8. Keep up to date with a company's product range. 9. Ensure that a company's products comply with the current regulations. 10. Formulate strategy for all regulatory submissions. 11. Participate in regulatory and customer inspections, review audit reports and submit compliance report to regulatory agency. 12. Maintain approved applications in compliance with appropriate guidance 13. Identifling the tlpe of changes & submit them as per country guidelines (life cycle management). 14. Monitor progress of all registration submissions country-wise and product-wise.

Carry out the manufacturing operations according to the BPCR provided by QA department Perform the Operations in accordance to the established SOPs and cGMP. To maintain for Good documentation practice .To execute Production planning schedule. Required Candidate profile < Qualification : B.sc /M.sc(Chemistry)/B. Pharmacy/B. Tech ( Chem engg) - Any chemistry Background. < Having Pharma Experience of 2- 8 Years of experience. Perks and benefits Free Bus , Canteen, Pf

Pfizer Walk-in Drive at Vizag for Manufacturing roles Job Title: Junior/ Assistant Associates Manufacturing (Injectables) Eligibility criteria: Qualification: Any Diploma/ BSc (Full time) Years of Experience: 1 to 6 Years should be from injectable manufacturing plant. Interview date & Time: Sunday, 13th April 2025 at 9:00 AM Venue: Hotel Best Western Ramachandra - Vizag # 8-8-36, GNT Rd, Medical Center, Gajuwaka, Visakhapatnam- 530026 Job Description Operate production equipment such as Injectable , Sterile , Parenteral machines, Vial / Ampoule filling , Capping , Compounding , Washing ,Sealing, Terminal sterilization, Stopper process & Visual inspection. Monitor and control the production process to ensure quality products are produced within specified parameters. Maintain accurate records of production data and perform routine maintenance tasks on equipment as required. Collaborate with other team members to resolve issues and improve overall efficiency. Ensure adherence to Good Manufacturing Practices (GMP) guidelines. Must have experience with USFDA regulatory environment & process.