99 Nda Jobs - Page 4

Provide expert regulatory guidance and strategic advice to clients on FDA regulations, policies, and procedures related to drug, biologic, and medical device development and approval. Review and interpret FDA guidance documents, regulations, and policies to ensure compliance and facilitate successful regulatory submissions. Support clients in preparing and submitting regulatory applications, including INDs, BLAs, NDAs, 510(k)s, and PMA submissions, and provide guidance on regulatory strategy and submission content. Conduct regulatory assessments and gap analyses to identify potential issues and risks in regulatory submissions and provide recommendations for resolution. Assist clients in preparing for FDA meetings, including pre-IND, pre-IDE, pre-NDA/BLA, and pre-PMA meetings, and participate in meetings as a regulatory representative. Monitor regulatory trends, changes, and updates from the FDA and provide insights and recommendations to clients on potential impacts on their products and programs. Collaborate with cross-functional teams, including regulatory affairs, clinical development, quality assurance, and medical affairs, to ensure alignment on regulatory strategy and objectives. Serve as a liaison between clients and regulatory agencies, including facilitating communications, responding to inquiries, and addressing regulatory challenges and issues. Qualifications: Bachelors degree in pharmacy, biology, chemistry, or related field; advanced degree preferred. Minimum of 5 years of experience working at the FDA in a regulatory role, with expertise in drug, biologic, or medical device regulation. Deep understanding of FDA regulations, guidance documents, and regulatory processes related to drug, biologic, and medical device development and approval. Proven track record of successful interactions with the FDA, including experience in preparing and submitting regulatory applications and participating in FDA meetings. Excellent communication and interpersonal skills, with the ability to effectively convey complex regulatory concepts and requirements to clients and internal stakeholders. Strong analytical and problem-solving abilities, with the ability to assess regulatory risks and develop strategies for mitigation. Regulatory affairs certification (RAC) or relevant professional certification (e.g., Regulatory Affairs Certification Board) preferred but not required. Ability to work independently and collaboratively as part of a multidisciplinary team, with a commitment to delivering high-quality regulatory support and guidance to clients.

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com . Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azuritys success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. ROLE AND RESPONSIBILITIES Role: Creation and revision of pharmaceutical drug product labeling for pipeline and commercial products in compliance with FDA regulations and guidelines and reports, ensuring continued regulatory compliance. Key Accountabilities: Regulatory labeling submissions across the product lifecycle management stages in compliance with FDA regulations and labeling guidelines. Responsibilities: Initiate and monitor the process for new and revised labeling requests according to internal procedures. Preparation, compilation of labeling documents i.e., Package Insert, Medication Guide, and Annotated Comparison of Reference Listed Drug (RLD) label with proposed labeling. Preparation of Structure Product Labeling (SPL) for all the original NDA, ANDA applications, amendments, and supplements. Preparation of Drug listing SPL for NDA, ANDA applications, drug product manufacturer, private label distributors upon product approvals and RLD revisions. Monitor FDA database and DailyMed for the RLD labeling updates and initiate the revision. Ensure regulatory compliance, accuracy, and version control of all new and revised labeling. Coordinate, monitor, and expedite labeling changes to meet established deadlines for FDA submissionand/or production schedules. Initiate and approve change controls for new and revised labeling. Participate in Azurity s Labeling Management Review Committee (LMRC) weekly meetings to finalize and approve labeling. Develop collaborative and respectful relationships with internal and external customers, including but not limited to, Packaging Operations, Marketing, Medical Affairs, Regulatory Affairs, Supply Chain, and artwork and print vendors to develop labeling. Ensure product labeling complies with FDA regulations and guidelines. Archive controlled label copies and master label files according to internal procedures. QUALIFICATIONS AND EDUCATION REQUIREMENTS 8-10 years of pharmaceutical labeling experience. Bachelor s degree: degree in scientific discipline preferred. Ability to read, understand, and follow FDA regulations and guidance documents related to labeling. Experience working on cross-functional teams. PERSONAL CHARACTERISTICS Strong attention to detail and deadlines Ability to multi-task Strong interpersonal skills and an effective communicator (phone, email, web-ex, video, in person) Strong sense of teamwork, ability to build collaborative relationships. Ability to recognize and escalate issues. Physical Mental Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to sit for long periods of time While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear May occasionally climb stairs and/or ride elevators The employee must occasionally lift and/or move up to 25 pounds Employee must be able to manipulate keyboard, operate a telephone and hand-held devices Other miscellaneous job duties as required

Avery Dennison is seeking an experienced IT Business Analyst with strong Legal and technology expertise. As a member of the IT organization, you will work closely with the legal operations function in order to understand their business challenges, technology roadmap priorities, and define requirements for scalable solutions. This role will require you to have strong experience with IT business analysis, project management, and stakeholder management. While this role will reside in the IT organization, the individual will partner closely with various teams including Legal, Enterprise Architecture, Sourcing and Finance among other functions to ensure solutions and systems are solving for a strong end-to-end experience. Responsibilities: Collaborate closely with various departments, particularly Legal, to enhance productivity and business growth through digital solutions. Build and maintain strong relationships with business partners, process owners, and key users to help improve their business performance. Understand and communicate business needs, challenges, and impacts, particularly within end-to-end business processes. Conduct thorough analyses to identify gaps or opportunities, translate them into business and technical requirements, and support the design and implementation of IT system changes aligned with overall IT strategy. For smaller projects, manage project scope, deliverables, budget, and timelines, while providing regular progress updates to stakeholders. Lead system improvements and drive user adoption through close collaboration with process owners. Promote innovation by identifying and presenting new technology opportunities. Drive the continuous improvement of IT practices, processes, and tools. Ensure timely resolution of issues related to both internally supported and vendor-managed technologies. Bachelor s Degree in a technical, quantitative, or analytical subject area. Or, work experience or advanced coursework demonstrating technical and analytical ability. 4+ years of relevant experience in an IT Business Analyst

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English - Expert 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 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 affairs tasks of building regulatory dossiers 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.You will be expected to collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? Life Sciences Regulatory Services Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Agility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Master of Pharmacy

Summary Sat Temsilcisi, m teri etkile imlerimizin ve sat performans m z n nde gelen itici g c d r. M teri deneyimi yakla m m z n y z d rler ve uyumlu ve etik bir ekilde sat b y mesini sa lamak i in m teriler ve hastalar i in de er sa layan derin ili kiler kurarlar About the Role Major Accountabilities ~ Rekabet i Sat B y mesi Sa lay n ~ Re ete kararlar n etkileyen veri analizi yoluyla y ksek potansiyelli m terileri (HCPler ve payda lar) belirleyin ve nceliklendirin ~ Olumlu m teri deneyimlerinin ustaca d zenlenmesi yoluyla sat performans n art r n ~ li ki kurun ve ili ki kurun ~ Kritik m teri zorluklar n , karar verme fakt rlerini, sorunlu noktalar ve f rsatlar anlamak i in de ere dayal konu malara (y z y ze ve sanal olarak) kat l n ~ M teri tercihlerini yans tarak, mevcut i erikten ve birden fazla etkile im kanal ndan yararlanarak hedef HCPler i in m teri etkile imi yolculuklar n ki iselle tirin ve d zenleyin ~ Novartis i in zaman i inde s rd r lebilir bir i birli i geli tirmek amac yla HCPlerle ortakl k kurarak kat l m sa lay n ~ htiya lar n dinleyerek ve sa l k hizmeti ortamlar n anlayarak klinik farkl la man n tesinde unutulmaz, m teri odakl deneyimler sunun ~ Fikir liderleri ve en iyi t bbi etkileyicilerle (b lge d zeyinde) etkili al ma ili kileri kurun ve hasta yolculu unu iyile tirmek i in mevcut davran lara meydan okuyun (do ru hasta, do ru zaman) ~ Derin M teri g r leri ve Anlay Geli tirin ~ Onlar i in neyin nemli oldu unu ortaya karmak i in m terinin i i hakk nda i g r ler toplay n ~ M teri geri bildirimlerini takip edin ve yan tlar ek de er yaratan ve beklentileri a an eylemlere d n t r n ~ lgili b lge, hesap ve m teri etkile im planlar n olu turmak, dinamik olarak nceliklendirmek ve ayarlamak i in mevcut veri kaynaklar ndan yararlan n ~ r n ve endikasyonla ilgili i eriklerin, kampanyalar n ve etkile im planlar n n geli tirilmesini desteklemek i in m teri i g r lerini ilgili i payda larla s rekli olarak payla n ~ M terilere ve Hastalara De er Kat n ~ Kar lanmam m teri ve hasta ihtiya lar n kar layan z mler tasarlamak ve uygulamak i in i levler aras ekiplerle uyumlu bir ekilde i birli i yap n ~ lerini y r tmelerine yard mc olmak amac yla m teri i in g venilir bir ortak olarak hareket etmek; renmek i in dinlemek; ili kiyi uyumlu ve etik bir ekilde derinle tirmeye al mak; katma de erli z mler retmek i in kendilerini konumland r rlar. ~ M terilere ve i arkada lar na effaf ve sayg l bir ekilde a k bir niyetle davranarak do ruluk ve d r stl kle hareket edin. Etik ikilemlerle kar la t n zda, do ru olan yap n ve i ler do ru g r nmedi inde konu un. Novartis Etik Kurallar , De erler ve Davran lar Kurallar na g re ya ay n. Key Performance Indicators Sat Temsilcisi, m teri etkile imlerimizin ve sat performans m z n nde gelen itici g c d r. M teri deneyimi yakla m m z n y z d rler ve uyumlu ve etik bir ekilde sat b y mesini sa lamak i in m teriler ve hastalar i in de er sa layan derin ili kiler kurarlar Work Experience ~NA Skills ~Sat Becerileri ~M teri G r leri ~ leti im Becerileri ~Etkileme Becerileri ~ at ma Y netimi ~M zakere Becerileri ~Teknik Beceriler ~Hesap Y netimi ~Fonksiyonlar Aras Koordinasyon ~Sa l k Sekt r ~Ticari M kemmellik ~Etik ~Uyma Language ngilizce

Legal Executive Location: Coimbatore Experience: 3-8 years Education: Graduation in Law or in related field Shift: General Shift Notice Period: Immediate Joiners Skills: Legal drafting, NDA & SOW experience, legal compliance

Urgent Opening with CarePal Group for Legal Intern Job Title: Legal Intern (6-Month Internship with Full-Time Conversion Opportunity) Location: Mumbai (Andheri - Marol) - WFO Qualification: LLB or LLM pursing last semester Stipend: As per industry standards Conversion: Opportunity to transition into a full-time role based on performance Company About CarePal Group: CarePal Group is a dynamic and rapidly growing company in the healthcare sector, committed to providing innovative solutions to enhance patient care and medical services. We are looking for a highly motivated and detail-oriented Legal Intern to join our legal team and contribute to our compliance, contract management, and corporate governance initiatives. Key Responsibilities: - Assist in drafting, reviewing, and negotiating contracts, agreements, and legal documents. - Conduct legal research on relevant laws, regulations, and industry best practices. - Support the legal team in compliance-related matters and regulatory filings. - Assist in handling corporate governance, intellectual property, and data protection matters. - Liaise with internal teams and external legal advisors on legal issues. - Maintain and update legal documentation, case files, and compliance records. - Assist in dispute resolution and litigation management as required (20% Litigation). - Handle non-litigation matters such as contract management, regulatory compliance, and legal advisory (80% Non-Litigation). - Keep track of legislative updates and their impact on the organization. Required Qualifications & Skills: - Pursuing or recently completed LLB from a recognized university. - Strong understanding of corporate and contract law. - Excellent research and analytical skills. - Strong written and verbal communication skills. - Ability to work independently and manage multiple tasks efficiently. - Proficiency in MS Office (Word, Excel, PowerPoint). - Prior internship experience in a corporate legal team or law firm is preferred. Why Join Us? - Opportunity to work in a fast-paced and growing healthcare company. - Hands-on experience with real legal matters and corporate compliance. - Guidance and mentorship from experienced legal professionals. - Potential for full-time employment upon successful internship completion Interested candidates share their updated resume to durgadevi.karpan@impactguru.com

Join our dynamic team in Jaipur! Since 2014, we ve been building high-performance software solutions that empower our clients to achieve their goals. We re a passionate community driven by quality and speed, delivering rapid, continuous updates to meet the evolving needs of our partners. Grow your career with us and contribute to impactful projects. Competitive total rewards We offer competitive total rewards, including salary and bonus, recognizing your valuable contributions. Flexible leave vacation policy Our flexible leave and vacation policy supports your personal and professional well-being. Learning Career Growth We provide the resources and support you need for continuous learning and career progression. Snacks Outings We provide snacks, beverages, and organized outings to enhance team camaraderie and well-being. Current Openings Lead Web Developer 2-3 Yrs Professional Experience Good knowledge of MVC Frameworks Btech, MCA or BCA Permanent / Full Time Junior Web Developer 0-1 Yr Professional Experience Knowledge of PHP and Relational Database

The Pharmacovigilance Lead will provide guidance and expertise on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and state of the art pharmacovigilance post approval. This role reports AD, Clinical Development and Pharmacovigilance. Duties and responsibilities As the Pharmacovigilance Lead, you will be tasked with applying sound judgment for the analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation The role will require the identification and implementation of all clinical standard-operating procedures in order to ensure GCP compliance The role serves as the senior clinical safety representative in the cross-functional development teams. You will be responsible for setting Ocugen's clinical safety strategy for these global projects. The role identifies potential challenges, risks and roadblocks associated with the global safety domain and works as a leader in developing solutions to address these The role ensures that the medical and process standards delivered at Ocugen are in alignment with following safety objectives expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients and the general public Responsibilities include overseeing the safety signal detection and medical signal evaluation process and analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion Providing a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unblinding clinical data to protect ongoing study participants and complete timely communications to Health Authorities Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards. Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication. Review and contribute to safety relevant SOP and improvement of safety relevant SOPs Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety Ensures regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function Set safety strategy based on strong product knowledge and biologicals safety experience that allows for successful IND (Investigational New Drug)/NDA (New Drug Application) filings and initiation of first in human studies Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports. Oversees development of core safety information for new products Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in Ocugen's studies. Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment including many interface departments and functions Complies with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure Promoting the safe and effective use of medicinal products in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public Contributing to the protection of patients and public health The role identifies tools necessary to facilitate safety surveillance and clinical safety assessment and to implement necessary risk management initiatives Interfaces with key high-level internal and external stakeholders, contributes to, and approves regulatory reports/submissions/queries. He/she independently addresses complex safety issues as a key decision-maker Provides strategic input into clinical development, due diligence, regulatory and issue management activities from a clinical safety perspective and represents the position of GCSP in internal governance committees and in discussions with Health Authorities Qualifications Degree in Medicine (MBBS, MD, Pharm D or equivalent) is required. Eight(3-8) years of pharmaceutical/biotechnology industry experience, of which at least six (6) should be in a safety role, with broad overview of all aspects of a PV system and specific experience in signal detection and risk management Experience and success in addressing and managing complex safety issues in the pre-approval and post-approval environment including interfacing with external regulatory bodies (written and verbal interactions. Eg. External Audits, Ad Coms, CHMP Oral Explanations, etc.) Knowledge of scientific data relevant to own products and across therapeutic area, including the competitive environment and the disease state Strong understanding of data capture, data management and statistical methods for the preparation and analysis of safety data in clinical trials Detail oriented, exceptional documentation practices, technical writing and verbal communication skills Ability to convey complex concepts through clear and concise messages Excellent problem solving skills, contingency planning and risk-mitigation strategies Ability to navigate and be successful in a fast-paced, highly matrixed work environment Working conditions This position operates in an office setting and may include 20% of travel from time to time. Physical requirements This is a largely sedentary role.

JOB DESCRIPTION We are seeking an experienced Legal Executive with relevant experience to join our legal team. The ideal candidate will be responsible for providing legal counsel, ensuring compliance with applicable laws and regulations, drafting and reviewing legal documents, and representing the company in legal proceedings. The Legal Executive will work closely with internal stakeholders to mitigate legal risks and contribute to the overall success of the organization Key Responsibilities Draft and review legal documents, including non-compete agreements, cease-and-desist letters, collection demands, settlement agreements, and severance agreements Conduct legal research on laws and precedents, with a focus on corporate law Draft and review NDAs, SOW s and relevant agreements Conduct legal research and analysis on a variety of legal issues, including but not limited to contract law, employment law, intellectual property law, and data privacy law Provide support on Legal Research, Compliance, Litigation and administrative support Assist with the development and implementation of compliance programs and policies. Qualifications Bachelors/Master s degree in Law/Legal discipline with 3 to 5 years of relevant experience Proven ability to draft and review various legal documents and conduct comprehensive legal research Should have knowledge of NDA, Vendor agreement, and SOW Preparation. Strong communication skills, both written and verbal Experience in assisting in the drafting, review, and negotiation of various legal documents, such as contracts, agreements, legal correspondence, and legal briefs Maintain and update legal databases and files, ensuring accuracy and confidentiality Assist in the preparation and filing of legal documents with relevant authorities (e.g., courts, regulatory agencies) Experience in the preparing organization of litigation materials, including discovery documents and exhibit

About the Job Brief description of the role, however not limiting to below points: Drafting, reviewing, and negotiating agreements, contracts, and legal documents. Ensuring compliance with all statutory regulations and legal frameworks applicable to NBFCs. Advising internal stakeholders on legal risks, implications, and strategies to mitigate potential exposures. Managing legal disputes and coordinating with external counsel for litigation matters, when necessary. Supporting lending operations by providing guidance on regulatory compliance and applicable laws. Collaborating with cross-functional teams to address legal queries and implement compliance measures across multiple vendor partnerships. A. Corporate Legal Agreements :- Vendor onboarding agreements, Software license agreement, Merchant Pay Agreement, Master Service Agreements, SaaS Agreements, Memorandum of Understanding, Sending Replies to Legal Notices, Contracts Execution, Co-lending agreements, term loan agreements including Deed of Corporate Guarantees, Banking related agreements, Deed of Hypothecation Data Processing Agreements NDA (Non Disclosure Agreements) B. Also, Proficiency in Contract Management Tools. Skills Required Strong expertise in drafting and reviewing legal documents and contracts. Excellent analytical and problem-solving skills to address legal and compliance challenges. Proficient in managing legal risks and advising on risk mitigation strategies. Strong communication and negotiation skills. Ability to manage multiple stakeholders and ensure timely resolution of legal matters. Experience Required : 5+ years in a similar role within an NBFC or a large organization. Qualification : LLB/LLM Job Location : Bengaluru

Look after the entire legal affaris of Projects under the guidance/advise of Legal Head (Mumbai) , including attending Courts, Maha-RERA, Appellate Tribunals, Government Authorities, Police Station wrt to all civil and criminal matters/complaints, if any; drafting / vetting Agreement for Sale, Allotment Letter, Application Forms and other marketing documents for residential launch; drafting/vetting Leave & License Agreement, Lease Agreement, Sale Deed, and related documents for Commercial Premises transactions; drafting/vetting the reply to be sent to the customers; drafting / vetting various documents/contracts wrt procurement & contracts; drafting / vetting various other legal documents/deeds/ NDA/commercial transaction documents; Send periodcal update/MIS to Legal Head (Mumbai) wrt Legal matters/pending legal assignments any other matters/assignments/works that may be assigned by the Legal Head;

Responsibilities Candidate must have experience in contracts drafting and negotiations based on varied business models with customers, vendors, and partners, including master services agreements, statements of works (SOWs), licensing agreements/software agreements, AMC agreements, inter-company agreements, amendments, change orders, and NDAs. Candidate must understand importance of healthy negotiations with the customers and their attorneys to close business deals as per expectations. Candidate will be required to interact with the various cross-functional departments, including the business, sales, finance, and commercial teams while providing legal advisory as a business enabler to multiple functions. Candidate must be able to manage database of all existing and future agreements for compliance and future need purposes. Candidate must timely highlight all those agreements/sow which are due for renewal(s). Candidate must have experience in legal research to provide sound legal advice in case there is any change in law/regulatory framework which has impact on organization business. Candidate should be comfortable in visiting external counsel office/court for company related matters. Candidate will also assist their reporting manager in day to day legal function including general administration and operations and other special projects as requested. Handling of company/ regulatory compliances. Handling Company secretarial compliance. Technical and Professional Expertise: Full time LL.B degree from a recognized law university. And Company Secretary qualification is mandatory. Candidate must have experience in data privacy laws and IPR related matters. Experience: Minimum 3-5 years post qualification experience with IT or Service industry and having work experience in the following areas of law - Contract Act, IPR and skills on drafting & negotiating commercial contracts, statement of work etc. Candidate must have drafting and negotiation skills. Candidate must have ability to identify and escalate business risks/issues in a timely and appropriately manner. Candidate must have strong analytical and communication skills and should be independent and self-motivated. Interested candidates can also share their CV at: gsingh15@fcsltd.com

Role & responsibilities: Prepare and manage regulatory submissions (e.g., Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), marketing authorization submissions). Ensure clinical trials are conducted in compliance with regulatory requirements, including Good Clinical Practice (GCP), ICH guidelines, and local regulations. Track regulatory timelines and manage submission deadlines for new drug applications, clinical trials, and so on. Preparation and review of clinical study reports along with preparation of Bio summary/summary tables, BTIF and other regulatory documents with the study data. Adhering to GCP to meet regulatory requirements, Verification of deviations from the Protocol, SOPs, GCP and other applicable requirements and taking preventive action and corrective action to prevent recurrence. Preparation of audit reports and suitable corrective and preventive action plans. To have experience in the Ethics Committee related activities. To liaison with Local Drug Authorities (DCGI/CDSCO) for regulatory approvals of Test Licenses, Amendments, for conducting BA/BE clinical studies in India. Timely notification to DCGI/CDSCO for study related updates Communicate with regulatory agencies to clarify requirements and resolve issues related to clinical trial approvals and submissions. Manage responses to regulatory queries and facilitate interactions between the client and regulatory bodies. To search literature on healthy population to support BA/BE NOC application To liaise CBN for regulatory approvals for conducting clinical studies in India. To coordinate with global regulatory authorities for regulatory strategic for various products and services Proactive co-ordination of all the necessary activities required regulatory submission. Preferred candidate profile: Education : Bachelor's degree in life sciences, pharmacy, or related field (Masters or advanced degree preferred). Experience : 5+ years of experience in regulatory affairs within a CRO or pharmaceutical/biotech industry, with at least 2 years in a managerial role. Knowledge : In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH), clinical trial regulations, and submission processes. Interested applicants can apply with their updated profile or Can send to email to hr@qpsbioserve.com

Job Title: Associate L2 Location: Mumbai, India Reporting Manager: Team Lead Role Summary: Work as a subject matter expert on contract drafting, review and management for US, UK and other jurisdiction clients for India Delivery centres. Performs QC based on project guidelines and client instructions Responsibilities and Duties: * Perform QC based on project guidelines and client instructions * Ensure quality standards are achieved * Liaise between the client and India delivery teams * Work as a team member * Work in developing project guidance materials * Creating and developing project knowhow documents and imparting training to the team on the same * Prepare and supervise Reports for Delivery * Ensure productivity and quality SLAs on projects are met * Performing additional tasks and responsibilities assigned * Maintain personal and team records of work done * Train team members on processes including contract review and management * Contribute in process improvement ideas and actively participate in process improvement initiatives * Manage timelines * Track and report quality for the QCed work and give feedback to reviewers * Ensures SLAs (timeline, Quality) are met individually and collectively as a team * Assist the project leads in reporting and other project issues Required Skills/Abilities: * Ability to read and understand highly complex contractual language to identify and flag client risks and suggest mitigation in lieu of clients playbook * High level of positive attitude (Can do attitude) and follow problem solving approach * Target Driven along with an eye for details * Quick learner and adaptive to any process change in a minimal time period * Flexible to work in rotating shifts * Fluent in written and verbal English * Ability to comprehend questions and respond appropriately (writing and verbal) * Knowledge of MS Office – Word * Logical thinking and good decision-making abilities * Work independently, self-learning attitude, disciplined, sincere and need less supervision * Responsible for compliance with ISO standards and other confidentiality Education and Experience: * Law Graduate with 3- 6 years’ experience of contract negotiation, administration, reviewing, drafting and management reporting, etc. Thanks with regards, Ritu Bhomia 300plusconsultant No:- 7428010236

Primary Responsibilities: Review and send contracts out for signatures using our e-signature function (Adobe Sign) Maintain contracts database and ensure availability of all executed contracts managed by EP within Ariba contracts module Plan and carry out Contract Administration and its related activities Audit contract key attributes such as dates, amount, contract terms, pricing and payment schedule Prepare monthly reports and dashboards Organization Purchase Obligation Reporting for annual 10-K filings Respond to and follow up on contract enquiries via group email inbox, telephone, or support incidents Liaise and attend meetings with Care Delivery Organizations (CDO), Optum Care, other company functions necessary to perform duties and aid business and organizational development Coordinate actions with internal procurement and legal teams if needed Performance Metrics Management: Investigates non- standard requests and problems, with some assistance from others Prioritizes and organizes own work to meet deadlines Generally work is self-directed and not prescribed Assesses and interprets customer needs and requirements Acts as a resource for others with less experience Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so Required Qualifications: Bachelors degree at the minimum Proficiency in MS Excel, MS Word, MS PowerPoint, MS Access, Adobe Acrobat Proven excellent communication skills Proven attention to detail and the ability to spot errors and inconsistencies Preferred Qualifications: Knowledge of Ariba Contracts Module and knowledge on creation of contract workspaces Knowledge on Adobe Sign, Ariba tool / any other ERP systems/P2P systems Knowledge of the Contract Types, Renewal process, Amendments Health Care Industry experience Should be aware of various contract templates like MSA, EULA, NDA, SOW, Order Form, etc.

We seek an experienced Manager of Legal and Compliance to oversee contracts, ensure regulatory compliance, and provide strategic legal support while leading the legal team and managing risks. Required Candidate profile Bachelor's/Master's in Law (LLB/LLM); CS qualification preferred. Proven experience in commercial contracts and compliance. Strong leadership, communication, and analytical skills are required. Perks and benefits 5 Days Working

Role & responsibilities: 1. Responsible for writing and managing Oracle SQL / PL SQL Backend Developer, schedule a job & email Oracle 2. Responsible for periodical database analysis, suggest and discuss internally and implement post approvals 3. Responsible for on-boarding new Vendors / Service Providers including VRM assessment etc. 4. Responsible for Purchase order release, SOW signing, NDA / agreements in coordination with Delivery / Infra Leads 5. Ensure coordination with Vendors for timely raising invoices, payment processing and releasing payments 6. Owner for tracking of IT Financials esp. Budget vs Actuals, Vendor payments etc. 7. Owner for Internal IT Stakeholders coordination and monthly IT Provisions Preferred candidate profile: 1. Above 5-7 years experience in Broking Domain 2. Hands-on experience on Oracle SQL / PLSQL database backend development is mandatory, at least 5-7 years of experience 3. Hands-on experience on API Integrations 4. Hands-on experience in end-2-end Vendor on-boarding, approval process, agreements tracking & payment processing 5. Team player with expertise in managing team and having open mind set for working with other Stakeholders Qualification required: Oracle or MS SQL Certification ( at least one certification on the latest releases ) Bachelor in B-Tech/Engineering/MCA/BSC IT Certification in Oracle Database SQL/PLSQL

JOB DESCRIPTION Position: Manager Job Location : Gurgaon (preferable)/Baroda/Mumbai Education : M. Pharm Department : Global Regulatory Affairs Specialty Pharma Job Responsibilities Serve as a Regulatory CMC Product team member and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU & Canada Ensure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuity The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal. Manage execution of CMC documentation including PIND/IND/CTA , original NDA/MAA , agency background packages and responses to health authority questions per established business processes and systems. Support new technology development within our Company. Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Branded products worldwide. Conduct all activities with an unwavering focus on compliance. May need to manage or mentor junior team members. Technical Skills: Hands of expertise of preparation & review of dossiers , response to queries, communication with agencies for developed markets like US/EU Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. Demonstrated sound understanding of related fields (e. g. , manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. Leadership Skills: Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Demonstrated effective leadership, communication, interpersonal and negotiating skills. Education Minimum Requirement: M-Pharm in pharmaceutical sciences Required Experience and Skills: 5-10+ years of hands-on experience in regulatory affairs This role needs a seasoned professional who is aware of the regulatory activities for NDAs , can work in R & D CFT and who has the management capability of leading a group of team members The candidate must be proficient in English; additional language skills are a plus. Good inter-personnel skills with ability to direct multi-departmental functions.

Urgent Opening with CarePal Group for Legal Intern Job Title: Legal Intern (6-Month Internship with Full-Time Conversion Opportunity) Location: Mumbai (Andheri - Marol) - WFO Qualification: LLB or LLM pursing last semester Stipend: As per industry standards Conversion: Opportunity to transition into a full-time role based on performance About CarePal Group: CarePal Group is a dynamic and rapidly growing company in the healthcare sector, committed to providing innovative solutions to enhance patient care and medical services. We are looking for a highly motivated and detail-oriented Legal Intern to join our legal team and contribute to our compliance, contract management, and corporate governance initiatives. Key Responsibilities: Assist in drafting, reviewing, and negotiating contracts, agreements, and legal documents. Conduct legal research on relevant laws, regulations, and industry best practices. Support the legal team in compliance-related matters and regulatory filings. Assist in handling corporate governance, intellectual property, and data protection matters. Liaise with internal teams and external legal advisors on legal issues. Maintain and update legal documentation, case files, and compliance records. Assist in dispute resolution and litigation management as required (20% Litigation). Handle non-litigation matters such as contract management, regulatory compliance, and legal advisory (80% Non-Litigation). Keep track of legislative updates and their impact on the organization. Required Qualifications & Skills: Pursuing or recently completed LLB from a recognized university. Strong understanding of corporate and contract law. Excellent research and analytical skills. Strong written and verbal communication skills. Ability to work independently and manage multiple tasks efficiently. Proficiency in MS Office (Word, Excel, PowerPoint). Prior internship experience in a corporate legal team or law firm is preferred. Why Join Us? Opportunity to work in a fast-paced and growing healthcare company. Hands-on experience with real legal matters and corporate compliance. Guidance and mentorship from experienced legal professionals. Potential for full-time employment upon successful internship completion. Interested candidates should send their resume to durgadevi.karpan@impactguru.com with the subject line "Application for Legal Internship CarePal Group."

Draft,review legal documents, including non-compete agreements, cease-and-desist letters, collection demands, settlement agreements,severance agreements,legal research on laws and precedents, with a focus on corporate law Draft and review NDAs, SOW

Position: Manager Grade : G10 Job Location : Gurgaon (preferable)/Baroda/Mumbai Education : M. Pharm Department : Global Regulatory Affairs Specialty Pharma Job Responsibilities Serve as a Regulatory CMC Product team member and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU & Canada Ensure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuity The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal. Manage execution of CMC documentation including PIND/IND/CTA , original NDA/MAA , agency background packages and responses to health authority questions per established business processes and systems. Support new technology development within our Company. Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Branded products worldwide. Conduct all activities with an unwavering focus on compliance. May need to manage or mentor junior team members. Technical Skills: Hands of expertise of preparation & review of dossiers , response to queries, communication with agencies for developed markets like US/EU Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. Leadership Skills: Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Demonstrated effective leadership, communication, interpersonal and negotiating skills. Education Minimum Requirement: M-Pharm in pharmaceutical sciences Required Experience and Skills: 5-12 years of hands-on experience in regulatory affairs This role needs a seasoned professional who is aware of the regulatory activities for NDAs , can work in R & D CFT and who has the management capability of leading a group of team members The candidate must be proficient in English; additional language skills are a plus. Good inter-personnel skills with ability to direct multi-departmental functions.

Responsibilities: Spearheading the management of the company's internal contract management tools Drafting of contracts (MSA, NDA, Legal Contracts, Service Agreements) for the client Negotiating commercial contracts with the clients (B2B clients only) Vetting of the contracts shared and proposed by the client for the services to be provided Maintain a roster for renewal of contracts and ensuring that contracts are renewed and active timely and all times Coordinating with finance team to understand impact of the rates and thus partnering with BD team to get better rates for the services Handle the overall contract management for a set of clients based out of the office. Candidate must have: Graduation in LLB. Minimum 5 years of relevant experience in Corporate contract drafting, vetting and reviewing. Minimum 3 years of relevant experience in Negotiations of rates. Minimum 3 years of experience in client communication and client meetings. Excellent Contract Drafting, reviewing, vetting and Negotiation skills. Amicable Personality to lead Contract Management and handle independent conversations with Client companies across India. You are a detail-oriented person and follow a stringent timeline with regards to the delivery of your contracts.

The Assistant Manager supervises the daily operations of the group and ensures that all the communications with clients are supported by emails, outlining agreed action steps, responsibilities, and deadlines. They are also involved in the preparation of budgets and forecasts for the group and comparing these with the previous budgets and forecasts. Our team is dedicated to creating long-term relationships with our clients and business partners, and we strive to provide a personalized and practical approach to our services. We take pride in our industry-leading services and are committed to helping our clients stay compliant with national and international legislation. Does this sound like a team you want to be a part of Additionally, we provide training, mentorship, and opportunities for growth. If you re ready to take on a challenge and make an impact, CSC is the place for you. What you ll do for us Experience in handling a portfolio of clients across diverse industries Develop an in-depth knowledge of existing and potential clients, their industry, and key contacts Meet prospective clients and prepare fee proposals, including follow-through until the job is accepted or rejected Responsible for filing and registering any document including forms, returns, and applications which may include drafting of letters and resolutions Advise the clients on the secretarial matters as and when required Handles the promotion, formation, and incorporation of companies and the related matters as when required by the client companies Manages all the tasks related to securities and their transfer and transmission Drafting and reviewing the Contracts as per the need of the business Manage and coordinate the Legal or Compliance Audit activities for the clients Completing all the legal compliances Handling all kind of secretarial documents of clients and keeping the tracker and record of the same for future purposes Keeping up to date with any regulatory or statutory changes and policies that might affect the clients organization Review of NDA, engagement letters, business contracts, MoU, financing agreement, service contracts, etc. for the clients Managing a small team as well Perform high-level review on staff s deliverables and add value to the work that has to be delivered to the clients Focus on providing good client service ensuring that clients receive prompt responses to requests and queries Ensure all communications with clients are supported by emails, outlining agreed action steps, responsibilities, and deadlines Responsible for ensuring that commitments made to the client are followed-up in a timely manner so that the clients are satisfied What technical skills, experience, and qualifications do you need Required Qualifications: Excellent verbal and written communication skills Moderate knowledge of Companies Act, Contract Act, Industrial Disputes Act, Insolvency Code, Stamp Act, Registration Act, etc. Ability to research on the matters as per the business Excellent analytical skills to analyse and opine on various statutory provisions Excellent client servicing skills and strong problem-solving skills Able to work independently and work under tight deadlines Able to train, lead and motivate a team of professional staff Meticulous, organized, detailed and deadline-oriented Preferred Qualifications: Qualified CS or Law Graduate is preferred Minimum 5 years of exposure in professional firms providing corporate secretarial services