1269 Regulatory Affairs Jobs - Page 5

Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering Responsibilities Global Pay Plus Testers. MT MX messaging , SWIFT payments Preferred Skills: Banking-GPP Financial Services Domain-Payments-GPP Generic Skills: Banking

Role & responsibilities Asst. Manager (Regulatory Affairs) 1. The Candidate must be M.Sc or B.Pharma or M.Pharma with 7-12 years of experience out of which minimum 3-4 years in regulatory affairs in EU, US markets, WHO GMP certified pharmaceutical formulation company. He will be responsible for all regulatory functions- domestic as well as exports. He will coordinate with other departments on regular basis. He will provide documentation support required for regulatory submission independently, including preparation and submission of dossiers for product and plant registrations in different countries as per latest guidelines. Exposure to Regulatory Audits & QMS system. Knowledge of Drug & Cosmetic Act, DPCO & All other guidelines related to pharmaceutical industries Responsible for monitoring of critical processes for R&D in compliance of operations, Quality Management and regulatory affairs. Preparation or Review of SOPs, BMRs, MFRs, PVP, PVR, PDR, Chemical compatibility of drug product/Drug substance specifications, MOA and change control to ensure compliance. To ensure new products registration and license renewal compliance to local regulations, as well as GMP, GDP and ISO requirement. Review of formulation development protocols, and technology transfer dossier (TTD) Performing literature reviews and staying up-to-date with the latest advancements in pharmaceutical research to contribute to the development of new products. Ensure compliance with regulatory requirements, including FDA and global regulations, and maintain up-to-date knowledge of industry regulations and guidelines. Oversee R&D tasks, ensuring proper documentation of records and prepared of reports submitted to regulatory authorities. R&D document and their findings to support quality assurance, and regulatory affairs processes. Co- ordination with Quality assurance, Quality control, Production, Warehouse & Engineering department, ensure GMP and EHS related to R&D functions. Establish operational, analytical and documentation standards aligned with industry best practices. Preferred candidate profile

Role : Senior Executive Qualification: M. Pharma/B. Pharma Experience : 4 to 8 Years Location : Dholka, Gujarat Responsibilities 1. Preparation and submission of registration and re-registration dossiers as per country requirements of ROW (Preferable Russia, CIS countries and WHO) 2. Arrangement for indent of Samples, Packing Material specimen, Impurities, Reference Standards as per submission requirement. 3. Query evaluation and submission with respective countries requirement within the required time frame. 4. Establish coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. 5. Post approval activities: Submission of variations to the terms of marketing authorizations for finished products as per respective variation guideline. 6. Preparation of COPPs (Certificate of Pharmaceutical Product) and FSC to be submitted to Local FDA approvals. 7. Preparation of Tender documents. 8. Support for activities of contract manufacturing product Preferred candidate profile Must have experience in Pharmaceuticals Industries

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

We are currently hiring for DSA I role with a minimum of 1 year experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Required Candidate profile A minimum of 1 year pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT) are Eligible

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Minimum Bachelor's or Masters degree in related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Are Applicable to Apply

Role & responsibilities Job Title: International Regulatory Affairs (IRA) Sr. Manager Location: Ahmedabad -HO Markets: CIS (Including EAEU), LATAM (Central and South America), Middle East, Africa, South East Asia. Key Responsibilities: 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 4. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others. 5.Develop and implement regulatory strategies across international markets (EU, CIS, LATAM, ROW, Asia, Middle East, and Georgia) to ensure timely submissions and approvals for product registrations and lifecycle maintenance. 6. Lead the preparation, review, and submission of CTD/eCTD/ACTD dossiers for multiple dosage forms including solid orals, injectables, topicals, and liquids for pharmaceutical and nutraceutical products, as per country-specific guidelines. 7.Manage lifecycle regulatory activities such as renewals, variations, line extensions, and prompt responses to health authority queries across global jurisdictions. 8.Maintain up-to-date knowledge of global regulatory and provide strategic recommendations based on updated guidelines and country-specific requirements. 9.Ensure regulatory compliance for labeling, artworks, inserts, and packaging as per regional regulations and internal quality standards. 10 .Support and participate in regulatory audits and inspections by ensuring the availability of complete and updated documentation and responses. 11.Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. Preferred candidate profile

1.To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all Latam and CIS , ROW Countries and other country as per company requirements. 2.Responsible for final review of dossier before submission. 3.To coordinate with technical team for documents required for dossier. 4.Responsible to gather data related for dossier through online sources, laboratories, manufactures etc. 5.Reviewing artwork for products as per relevant regulatory authority requirements. 6.To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; 7.Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. 8.Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. 9. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 10. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. .

Dear All, We are looking candidates for our R&D Centre in Drug Regulatory Affairs for Europe market. Company Name : V-Ensure Pharma Technologies Pvt. Ltd Location : Koparkhairane Role & responsibilities 1. Head and mange EU including UK regulatory team 2. Handle & lead the team for successful approval. 3. Define regulatory strategy for EU filings 4. Preparation of regulatory strategy & checklist as per country specific requirements. 5. Coordinating with cross functional departments ADL/FRD/QA/AL to procure the documents for review and compilation. 6. Coordinating with BD/Client/Vendor as per documents requirement. 7. Reviewing all CMC documents for adequacy and accuracy before compilation/ submission of Dossiers. 8. Preparing, reviewing, compiling & submission of Dossier in CTD format/regional format as per country specific requirements. 9. Review & submit all the required documents Client and or as per market requirement. 10. Client/MOH queries response for successful approval. 11. Preparation & monitoring and submission of Post approval documents 12. Review of site transfer documents for successful approval. Preferred candidate profile Job Role : Manager / Sr. Manager DRA Qualification : B.Pharm / M.Pharm Candidate must have experience in Pharma Formulation company in DRA for EU market Perk & Benefits : Best on Industry Standard

As an experienced professional in the pharmaceutical industry, you will be responsible for ensuring the pharmaceutical, medical, and regulatory accuracy of English product information for European procedures. In this role, you will work with innovative, biosimilar, and generic products, contributing to regulatory compliance and addressing internal and authority-related inquiries. Your day-to-day activities will involve creating and updating compliant English product information for EU procedures, strategic planning for changes affecting multiple product documents, evaluating and approving change requests, and coordinating submissions with EU regulatory units. Additionally, you will collaborate on patent-related issues, contribute to readability studies, and ensure compliance with legal requirements. You will also be involved in monitoring safety updates from EU authority websites, tracking reference product updates and legal changes, assessing the need for updates based on Company Core Safety Information, implementing safety updates in line with SOPs, and participating in Product Safety Group Meetings. Your role will also include scientific work, authority communication, coordination of packaging mockups, addressing authority queries, and assisting with training new team members. To excel in this position, you should have 6 to 7 years of experience in medicinal information and EU labeling in the pharmaceutical industry, ideally in Regulatory Affairs. A completed university degree in natural sciences, such as Pharmacy, Biology, Human Biology, Medicine, or Food Chemistry, preferably with a PhD, is required. Proficiency in spoken and written English, strong MS Office skills, and knowledge of European pharmaceutical law and regulatory affairs are essential for success in this role. If you are looking to be part of a global team dedicated to making good health more affordable and accessible, this opportunity to contribute to the regulatory compliance of life-changing medicines may be the perfect fit for you.,

As a Manager of Operations at ZOLL, you will play a crucial role in organizing and overseeing the daily operations of our company. Your primary responsibility will be to ensure that our business functions smoothly and efficiently by managing procedures and guiding our team members. Your role will encompass a wide range of operational tasks, necessitating a deep understanding of various company processes. We are seeking a competent individual who can effectively plan and execute diverse operational activities, demonstrating strong leadership qualities to optimize the business operations. Your goal will be to enhance the efficiency of our operations, fostering growth and long-term success. Key Responsibilities: - Supervise operational departments including Warehouse & Supply Chain, Tech Service, Regulatory Affairs, and IT - Collaborate with department managers to make decisions on operational activities and establish strategic goals - Provide guidance and feedback to staff members from different departments - Continuously assess the effectiveness of business procedures in alignment with organizational objectives and implement enhancements - Manage procurement processes and coordinate resource allocation - Enhance tech service activities, streamline processes, improve team efficiency, and drive profitability - Monitor financial data, adjust operational budgets, and prioritize profitability - Develop, revise, and enforce policies to ensure compliance and operational efficiency - Analyze performance metrics and data to evaluate overall business performance - Ensure legal compliance and adherence to established regulations - Implement lean management practices to optimize inventory management and enhance working capital - Identify opportunities for cost-saving initiatives across the business - Stay updated on technological advancements within the industry Qualifications: - Tertiary qualifications in business administration, preferably with an engineering background - Over 10 years of experience in a well-established multinational medical company, preferably in the medical equipment sector - Proven track record as a Manager of Operations or in a similar leadership role within the industry - Sound knowledge of legal regulations in the industry - Proficiency in various business functions such as supply chain, finance, and customer service - Familiarity with data analysis, performance metrics, and business software like MS Office and Oracle - Strong commercial acumen and the ability to identify business improvement opportunities - Excellent stakeholder management skills and the capacity to communicate complex business concepts effectively - Self-motivated individual with a drive for operational excellence - Professional demeanor, excellent communication skills, and adept at working both independently and collaboratively ZOLL is a rapidly expanding global company operating in over 140 countries. Our dedicated team is committed to making a positive impact on patients" lives, and we foster a culture of innovation, self-motivation, and entrepreneurship. Join us at ZOLL as we strive to enhance outcomes for underserved patients with critical cardiopulmonary conditions and contribute to saving more lives.,

Responsibilities: * Collaborate with cross-functional teams on product development and launch. * Ensure compliance with regulatory requirements throughout lifecycle. * Manage medical device submissions and recalls. Annual bonus Over time allowance Travel allowance

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to customers across different geographies. The business is structured into two main segments: Specialty Pharmaceuticals and Generics & APIs. Specialty Pharmaceuticals includes Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. Generics & APIs include Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. The company operates manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, focusing on APIs and Dosage manufacturing. The Mysore manufacturing site, spread over 69 acres, is USFDA approved and manufactures APIs targeting Lifestyle-driven Therapeutic Areas like CVS and CNS. It is a market leader in four APIs and among the top three players for another three APIs. The Roorkee facility is state-of-the-art and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO, and Brazil ANVISA, focusing on a B2B model for EU, Canada, and emerging markets. Both manufacturing units are backed by around 500 research and development professionals based at Noida and Mysore. The R&D team works on developing new products in API, Solid Dosage Formulations, Sterile Injectable, Semi-Solids Ointments, Creams, and Liquids. In-house BA/BE studies are conducted at an 80-bed facility with global regulatory accreditations. JGL's Regulatory Affairs & IPR professionals manage a unique portfolio of patents and product filings in regulatory and non-regulatory markets. Jubilant Pharma's revenue has been on a consistent growth trajectory, with INR 53,240 Million in the Financial Year 2018-19 compared to INR 39,950 Million in 2017-18. For more information about the organization, please visit www.jubilantpharma.com.,

: Prepare and maintain the Signal Schedule as per Standard Operating Procedures. Identification, Analysis, and Evaluation of safety signals arising from various data sources to determine signals or risks that could result in changes to labels and / or benefit-risk profile of the product. Evaluate the safety information and prepare product specific ADR (Adverse Drug Reaction) Sheet. Author Drug Safety Report (DSR) for Valid signals as per Standard Operating Procedures. Communicate findings from routine and ad hoc signal detection and assessment activities to concerned stakeholders. Contribute to cross-functional initiatives aimed at improving pharmacovigilance capabilities related to signal detection. Maintain awareness on new or revised regulatory requirements and guidelines relevant to Signal Management. Ensure regulatory compliance (quality, procedures, regulations, timeliness, consistency) for Signal Management process. Assist in preparation/revision of SOP, Work instructions, templates and guidance training documents concerning Signal Management. Impart trainings related to Signal Management activities, as and when required Skills Required: Regulatory Medical Writing | Intermediate Medical Literature Review & Analysis | Intermediate Adverse Event Reporting & Signal Detection | Advanced Regulatory Affairs Collaboration | Intermediate Safety Data Analysis & Visualization | Advanced

We are looking for a highly skilled and experienced Legal Receivable Officer to join our team at Equitas Small Finance Bank. The ideal candidate will have 14 years of experience in the BFSI industry, with expertise in legal receivables. Roles and Responsibility Manage and oversee the collection process of outstanding debts from customers. Develop and implement effective strategies to minimize bad debt and improve cash flow. Collaborate with internal teams to resolve customer disputes and payment issues. Analyze and report on delinquency trends and provide insights for improvement. Ensure compliance with regulatory requirements and company policies. Maintain accurate records and reports of all transactions and interactions. Job Requirements Strong knowledge of legal principles and practices related to receivables. Excellent communication and interpersonal skills for interacting with customers and internal stakeholders. Ability to work in a fast-paced environment and meet deadlines. Strong analytical and problem-solving skills to identify and mitigate risks. Proficiency in using software applications and systems for managing receivables. Experience working in the BFSI industry, preferably in a similar role.

We are looking for a highly skilled and experienced Receivable Officer to join our team at Equitas Small Finance Bank. The ideal candidate will have 1-4 years of experience in the BFSI industry, preferably with a background in receivables. Roles and Responsibility Manage and oversee the collection process to ensure timely recovery of outstanding amounts. Develop and implement effective strategies to minimize bad debt and improve cash flow. Collaborate with internal teams to resolve customer complaints and disputes. Analyze financial data to identify trends and areas for improvement in the receivable process. Ensure compliance with regulatory requirements and company policies. Maintain accurate records and reports of all transactions and interactions. Job Requirements Strong knowledge of accounting principles and practices. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet deadlines. Proficient in Microsoft Office and other relevant software applications. Strong analytical and problem-solving skills. Ability to maintain confidentiality and handle sensitive information. Experience working in a similar role within the BFSI industry is preferred.

We are looking for a skilled Technical Manager with 4 to 7 years of experience to join our team at Equitas Small Finance Bank in the BFSI industry. Roles and Responsibility Manage and oversee technical projects from initiation to delivery, ensuring timely completion and quality results. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and implement technical solutions to meet business needs, leveraging expertise in BFSI technologies. Provide technical guidance and support to junior team members, promoting knowledge sharing and skill development. Analyze project performance data to inform decision-making and optimize processes. Ensure compliance with regulatory requirements and industry standards in all technical aspects of the bank's operations. Job Requirements Strong understanding of BFSI technologies and their applications in financial services. Proven experience in managing technical projects with a focus on delivering high-quality results. Excellent leadership and communication skills, with the ability to motivate and guide teams. Strong analytical and problem-solving skills, with attention to detail and strategic thinking. Ability to work effectively in a fast-paced environment, prioritizing multiple tasks and deadlines. Experience working with small finance banks or similar institutions is highly desirable.

JD for Regulatory Affairs Executive We have requirement who have experience in AERB CDSCO BIS Plastic Waste ISO Share your cv - rekha@mi.konicaminolta.in

The Apex Group was established in Bermuda in 2003 and is now one of the worlds largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion. Thats why, at Apex Group, we will do more than simply empower you. We will work to supercharge your unique skills and experience. Take the lead and well give you the support you need to be at the top of your game. And we offer you the freedom to be a positive disrupter and turn big ideas into bold, industry-changing realities. For our business, for clients, and for you Business - Global Payments Job Location - Pune/Bangalore (North BCIT only) TheTransferAgencyDepartmentprovidesFundAdministration servicetonumerous Fund management companies covering the full range of shareholder servicing functions including Transaction processing, Reporting, AML and Registration and Payments. The department is responsible for Client and investor document management, processing and quality checking of transactions and updating the registers of clients in response to investor instructions. ThisroleistoperformBAU activitiesintheTAdepartment toensurethatnotonly Client Service Level Agreements are consistently met and/or exceeded but also to ensure that regulatory requirements are effectively met. Candidates should be flexible enough to work in 24*7 environment Keydutiesand responsibilities Individual/Youshouldhavefairunderstandingof SWIFT(MT103,MT202),FED payment, Internal Transfer, FX transactions Individual/YouShould haveknowledgeaboutABA,SortCode, BSB,BIC,IBAN, RTGS,NEFTand variousglobal bankingcodesandcashsettlementsmethods. Individual/YoushouldhavepriorexperienceworkinginManualPayments/wires environment and able to understand end to end Payment flow. Individual/YoushouldbeabletoreadStandardsettlementInstructions ( SSIs ) and identify any missing/incorrect information. FundrelatedvendorpaymentInvoiceverificationandmakingPaymentusing banking portals. Custodyandfundrelatedbankinvoice verification. Individual/Youshouldbewellversedwithpaymentsrelatedtosubscriptionand redemption. Mailboxmonitoringandprioritisingpaymentsbasedonvariouscurrencycutoffs. Theroleinvolvessupportingvariousgloballocationswithday-to-dayPayments requirement. AnswerClient/LocalOfficesqueriesbycallandemail. Ensurealldailyprocessingcompletedandsignedoff. Reportandescalateregularlyonsignificantissuesandblockingpointstomanager. Mustbea teamplayer,capableofmulti-taskingandableto workwithin tight deadlines Shouldhavegoodwrittenandverbalcommunicationskills. Shouldbeflexibleinanyshifttimings. PriorexperienceinPayments/Banking/Treasurywillbeanaddedadvantage. PriorexperienceinInvestment Banking Payment functionswillbeanaddedadvantage. QualificationandExperience UniversitydegreeinB.Com/MBAorequivalentdegree Knowledgeof hedgefunds,PrivateEquitywillbe andaddedadvantage. HandsonexperienceandknowledgeaboutFEDPayment andSWIFTpayments. Experienceofabove3yearsinmanagingFX/Paymentsprocessing,investigations with fair knowledge . 3-15yearsofrelevantexperience SkillsRequired Stronganalyticalskills Responsibleformeetingallclientdeliverables Abilitytonavigateproficientlyinawindowsenvironment StrongknowledgeofMicrosoftexcel&word Abilitytowritemessagesinaclearandconcisemanner Abilitytoread,write& speakEnglish proficiently Strongresearch,resolution,andcommunicationskill Interpersonalskills-Relationshipbuilder,respectfulandresolvesproblems Communicationskills-Presentationskills,listeningskills,oral&written communication skills Self-management-Adaptabilityandresilience,learning behaviour,integrityand ethics and relationship build Motivationalskills-Performancestandards,achievingresultsandpersistent. Innovativethinking-Creativethinkingdecisionmaking,inputseeking,logical thinking and solution finding Attentiontodetailandabilitytoworkonmultiple tasks Flexibleenoughtoworkinanyshiftsasperbusiness needs PriorTransferAgencyprocessingexperienceisrequired Mastersdegree in commerceisdesired Careerwith Apex Agenuinelyuniqueopportunitytobepartofanexpandinglargeglobalbusiness Exposuretoallaspectsof thebusiness, cross-jurisdictionandtoworkingwith senior management directly Additionalinformation We are an equal opportunity employer and ensure that no applicant is subject to less favourable treatment on the grounds of gender, gender identity, marital status, race, colour,nationality,ethnicity,age,sexualorientation,socio-economic,responsibilitiesfor dependants, physical or mental disability. Any hiring decision are made on the basis of skills, qualifications and experiences. We measure our success as a business, not only by delivering great products and servicesandcontinuallyincreasingourassetsunderadministrationandmarketshare, but also by how we positively impact people, society and the planet. FormoreinformationonourcommitmenttoCorporateSocialResponsibility(CSR) please visit our CSRpolicy page . If youarelookingto takethatnext stepinyourcareer andarereadyto workfora high performing organisation, alongside talented people who take pride in delivering great results, please submit your application (with your CV, cover letter and salarys expectations) to our dedicated email address. (neha.j-pandey@apexgroup.com) Websiteaddress: https://theapexgroup.com DisclaimerUnsolicited CVs sent to Apex (Talent Acquisition Team or Hiring Managers) by recruitment agencies will not be accepted for this position. Apex operates a direct sourcing model and where agency assistance is required, the Talent Acquisition team will engage directly with our exclusive recruitment partners.

Education Qualification - Pursuing or completed BSc or MSc in Microbiology, Life Sciences, or Biotechnology What We Want You To Do Execute required activities as part of ISO 13485 and ISO 15189 compliance Undertake activities as part of manufacturing documentation under ISO 13485 Undertake activities in molecular kit development and kit packaging departments Preparation of regulatory document dossier Requirements The candidate must have the ability to execute tasks and document information independently. Have a basic understanding of quality assurance and quality checks Awareness of ISO 13485 and ISO 15189 Skills Keen attention to details. Ability to critically evaluate scientific literature and integrate information from multiple sources. Proficiency in Google & Microsoft Office Suite and other relevant software applications. Ability to work independently with minimal supervision as well as collaboratively in a team environment. Excellent organizational and time management skills with the ability to prioritize tasks effectively Strong interpersonal and communication skills with the ability to interact professionally with diverse stakeholders Note: This is a paid internship.Skills: time management, regulatory documentation,documentation,iso,regulatory affairs,molecular kit development,genomics,quality assurance processes, google suite,interpersonal skills,iso 13485,microsoft office suite, proficiency in google & microsoft office suite,iso 15189,attention to details,quality assurance,biotechnology, communication,communication skills,scientific literature evaluation, organizational skills

Company Name: Exemed Pharmaceuticals Designation - Drug Regulatory Affairs -Officer/Sr Officer Location - Vadodara ( Corporate Office) Market: Domestic Primary Job Descriptions Having knowledge of SUGAM portal and CDSCO website Submission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC. Application of CT-05 / CT- 04 Application of CT-10 / 12/ 13 Application of import Licenses [CT-16/ Form 12/Form 08] Knowledge of IPC submissions Form 29 application Preparation of presentation for Subject Expert committee (SEC) Product Lifecycle & Management Additionally, should be well verse with Preparation of Module 4 & 5 Nonclinical & Clinical data Preparation of Pack Insert (PI), Patient information leaflet (PIL) and Summary Product Characteristics (SPC) Literature Search (Nonclinical, Clinical, Formulation etc.) Preparation of Product Monograph Preparation of different types of rationales (for FDC, efficacy, dosing etc.) Aware of BABE Guidelines/ CT Phase III guidelines & Animal Toxicology

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activities, ensuring that the applications are aligned with business needs and technical specifications, while fostering a collaborative environment that encourages innovation and efficiency. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure timely delivery of milestones. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP HCM Payroll.- Strong understanding of payroll processing and compliance regulations.- Experience with SAP HCM modules and integration with other systems.- Ability to troubleshoot and resolve application issues effectively.- Familiarity with data management and reporting tools related to payroll. Additional Information:- The candidate should have minimum 7.5 years of experience in SAP HCM Payroll.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Coordinate 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 sBachelor Degree in Life Sciences Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation