156 Ctd Jobs - Page 4

The Regulatory Data & Systems Senior Associate will be responsible for interpreting and executing business requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves optimizing complex data systems supporting the health authority submission process, while ensuring compliance with regulatory regulations and guidance. The ideal candidate will have a strong background in system analysis and data science/AI in a regulated industry. Roles & Responsibilities: Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory requirements. Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices. Project Coordination Assist in planning, tracking, and executing departmental projects and initiatives. Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates. Required Knowledge and Skills: Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors. 5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies. Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner. Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction. Familiarity with GxP requirements and systems validation. Life Sciences, Biotech or pharmaceutical industry experience. Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault Familiarity with global regulatory processes and standards. Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment. Basic Education and Experience: Bachelor’s degree and 2 years of directly related experience Associate’s degree and 6 years of directly related experience High school diploma / GED and 8 years of directly related experience Preferred Education and Experience: Practical experience with regulatory data standards, such as IDMP 5+ years’ experience in data management, machine learning, or related fields

The Senior Associate, Data Management, will help drive key business operation initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations. You will lead efforts to implement and support regulatory processes, ensuring compliance, efficiency, and the delivery of high-quality regulatory information. As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams to guide regulatory initiatives, ensuring the smooth adoption of new processes and system use. You will also play a key role in training and developing data standards, ensuring teams are equipped to meet the evolving demands of the regulatory landscape. Your expertise will help shape the future of regulatory operations by streamlining processes and driving compliance across global markets. Roles & Responsibilities: Responsible for maintaining data within the Regulatory Information Management (RIM) system Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system Serve as a Data Management SME within cross-functional collaborative initiatives Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives Provide support on creating, running and analysing reports for data streamline projects Develop and deliver training materials and presentations to a global audience Manage the protocol Amendment New Investigator (PANI) submission updates Manage 1572 forms for FDA submission Provide support within the global data management team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods. Adhere to Amgen processes, policies, guidelines, SOPs and training documentations. Required Knowledge and Skills: Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance In depth understanding of the Veeva Vault system Good written and verbal communication skills Detail oriented Independent time management and prioritization skills Work efficiently with little support and minimal to no supervision Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect Critical thinking skills Appropriate software skills as required Strong analytical and problem solving, communication and presentation skills Good understanding of business complexity and project inter-dependencies Be a great teammate who can work effectively at all levels of an organization with the ability to influence others to move toward consensus Fluent in English, both in oral and written communication Experience in supporting projects / improvement initiatives Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM Be open to working in a dynamic environment embracing change as a constant and adopting new technologies Working in global teams and matrix organizations Able to follow through on tasks and motivate others to meet deadlines Basic Education and Experience: Master’s degree and 1-2 years of directly related experience OR Bachelor’s degree and 2-3 years of directly related experience OR Associate’s degree and 3-5 years of directly related experience OR High school diploma / GED and 5+ years of directly related experience Preferred Education and Experience: Practical experience with CTIS system

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Looking For Junior & Senior Regulatory Affair Officer - Preparing dossiers as per country specific guidelines Junior : - 1 - 3 Years ( Vadodara Location) Senior : - 3 - 5 Years ( Vadodara Location) Salary will be Based on Experience

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Any job assigned by immediate supervisor/HOD Preferred candidate profile Experience required - Pharma API background Perks and benefits As per industry

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Department - Regulatory Affairs Designation - Sr. Officer No. Of Vacancy - 2 (1 Male/ 1 Female) Qualification - M.Pharm Required Experiance - 2 3 Years/2 5 Years Key Roles ( As per JD) Prepare Dossier According the Guidelines Co Ordinate & Communication with Business Development team regulatory Compliance Review all DMF, F&D, QC, Production & Packaging Department Documents and API Manufacture Documents for Prepare Dossier Checking and Approvals for Artwork for Different Countries including Contract Manufdacturing Prepare and submission of COPP, FSC and Product Permission in FDCA. Industry - Pharma(Injectables) Regards, Darshana cv.naukri@evokehr.com

Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives : Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department. Gathering of technical information from various sources. Preparation of Dossiers, Submission of dossiers. Preparation of applications to regulatory bodies for all necessary approvals. FDA, CDSCO, international regulatory bodies. Review of dossiers of pharmaceutical products Answering queries of regulatory bodies connected with product registration. Overseeing of the regulatory process filing necessary applications and handling all government interactions. Coordinating the inspection of the organization facilities and contract facilities, and developing procedures to ensure regulatory compliance. Managing subordinate staff in the day-to-day performance of their jobs. Ensuring that project/department milestones/goals are met while adhering to approved budgets. Accompanying development projects and revising already existing technical documentations. Communicating with responsible regulatory authorities (national/international) as well as with notified bodies. Being the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of pharmaceuticals products and nutritional supplements. Training team members to fulfill their job functions and improving their skills. Staying informed about any changes in legislation etc. Skills needed Indian FDA guidelines knowledge Understanding & knowledge of standards of various international regulatory bodies SA/ZAZIBONA/EU. Organizational Skills- Work assignment, time management, working within strict time frames. Ability to solve regulatory queries & compliance matters. Knowledge of dossier types and filing requirements. Responsibilities of a Regulatory Executives / Officers : To prepare and compile registration dossier as per the specific country guidelines and submit to regulatory authorities. To prepare, review compile re-registration documents. To prepare & review /check artwork, pack insert, SmPC etc. To study Regulatory guideline of assigned countries and to prepare checklist / template for registration dossier. To verify specification of excipients, active, finished product and packaging material and all required documents. Application, review, co-ordination, follow-up of legal documents COPP, FSC etc. Maintain Proper database w.r.t to master document dossier. To collect and verify all technical documents and information from various departments at the manufacturing site. Provide Regulatory support to various departments. Review follow-up and co-ordination for registration samples /WS and impurities required for analysis purpose. To reply any queries raised by respective regulatory authority, in timely manner. To maintain and update Registration certificate /information in regulatory data base. Requirement : Prefer professionals with experience in Document (Process, Analytical) review, Dossier preparation and Submission- for ROW, EU and Other country. Regulatory Affairs Manager - 5 +10 years experience of working in the regulated markets Regulatory Affairs Senior Executive / Officers - more than Two years experience in Pharma Regulatory Affairs will be preferred Required Candidate profile for Manager Level Effective oral and written communication skills. Must be flexible and capable of managing personnel Must have a systematic approach to solving problems. Must be able to keep calm and make quick, clear decisions while coping with pressure. Must be able to understand the techniques and processes used Excellent PC skills , should be proficient with the usage of the internet as a tool to find necessary & useful information. Must be organized- timely, and with information/data

Ensure that submission of CTD, eCTD, aCTD dossiers. Meet all regulatory requirements. Participate in contacting competent authorities for respective products. Preparation of regulatory submissions (Dossier, Variations) to authorities. Required Candidate profile Should have deep knowledge of Preparation and submission CTD, eCTD and ACTD Dossiers to ROW drug regulatory authorities. Should be able to handle queries, Artworks check, regulatory planning.

VMA Architects is looking for Civil Engineer Auditor to join our dynamic team and embark on a rewarding career journey Developing detailed designs. Doing feasibility assessments and site inspections. Preparing and implementing project plans. Researching and providing estimates for projects. Reviewing government regulations and ordinances. Monitoring and optimizing safety procedures, production processes, and regulatory compliance. Making recommendations or presenting alternative solutions to problems. Confidently liaising with clients and other professional subcontractors. Project management duties (e.g. managing budgets, resources, and deadlines; acquiring and compiling quotes, etc.)

Oversee the preparation, review, and submission of regulatory filings, including DMFs, ANDAs CTD submissions, and other relevant documentation. Document review Preparation and submission of DMF to various countries. Review & verification of BPCRs , PVP/PVR and method validation reports. Regularly updating and maintaining regulatory work sheets for monthly management review. Review and compiling vendor Qualification Documents and ROS etc. Review and compiling of CMC documents. Gathering and reviewing documents received from QA and other departments. Compilation of technical Data Packages, Quality Overall Summary & Open Part DMFs. Preparing US DMFs for USFDA, ASMF, CEP etc. Preparing Customer query response to AP/OP DMfs & TDPs raised by various customers. Preparing Applicant Part/ Open Part DMFs to various Customers. Preparation of LOAs LOEs, others declarations & commitment based on customers.

As a Regulatory Affairs Specialist at Lifesigns, you will be responsible for regulatory submissions, compliance, and documentation to ensure adherence to medical device regulations across jurisdictions. You will assist in maintaining regulatory files, managing product registrations, responding to regulatory inquiries, and supporting external audits. Your expertise in regulatory approvals, standards compliance, and medical device reporting will be essential in securing and maintaining market access for Lifesigns' solutions. Key Responsibilities Prepare, analyze, and edit technical documents for regulatory submissions in India, the USA, and Northeast Asia. Work with internal teams to ensure compliance with submission requirements and documentation standards. Maintain and update regulatory files, registrations, and listings, including ISO, CDSCO, 510(k), CE dossiers for EU, and NRTL certifications. Support renewals, device listings, site registrations, supplements, and annual reports. Prepare responses to regulatory authority queries within assigned timelines. Stay updated on regulatory procedures, industry guidelines, and compliance changes. Assess device-related incidents/complaints for medical device reporting (MDR) requirements and submit reports as needed. Handle recalls and field actions, ensuring timely reporting to regulatory bodies. Review and approve product labels and promotional materials for compliance with applicable regulations and technical standards. Provide regulatory support during external audits, helping minimize risks of non-compliance. Assist in clinical trial site ethics review board applications and prepare interim or final reports for review boards. Perform other regulatory duties as assigned. Qualifications B.E. in any discipline (preferably BME, ECE, or Mechanical Engineering). 3 5 years of experience in regulatory affairs within the medical device industry. Strong understanding of global regulatory frameworks, including FDA, CDSCO, ISO, MDR, and CE requirements. Experience in regulatory documentation, compliance management, and submission processes. What We Offer Competitive salary and performance-based incentives. Opportunities for professional growth and career advancement. Comprehensive training programs and continuous learning opportunities. A supportive and collaborative work environment. The chance to make a significant impact on healthcare technology compliance.

Role & responsibilities - Preparation of CTD and ACTD Dossiers. - Should have knowledge about Southeast Asian guidelines for Dossier preparation. - Preparation and Reviewing Artwork - Coordination with manufacturers regarding quality documents. - Reviewing quality documents - Should have sound knowledge of FDA related work. (Product Permission, COPP, Mfg. License, GMP certificate). - Prepare and submit query response within timeline.

We have opportunity in Regulatory Affairs for Emerging Markets Position: Officer/Executive Regulatory Affairs Experience: 2-5 Years Qualification: B.Pharm/M.Pharm Location: Pune Compilation of dossiers in CTD, eCTD & national formats Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for new product filing Maintaining product Life cycle Candidates having experience LATAM/CIS/ Africa or any other Emerging Markets can apply If relevant and interested, pls apply

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Senior Executive/Assistant Manager/ Deputy Manager based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 7 - 15 yrs. with dossier filling experience in MEXICO or South East Asian Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skill Job Responsibility: Compilation and review of product license applications, variations, and renewals for Mexico country as per regulatory requirements respectively with minimal supervision Manages electronic documents and creates electronic submissions in CTD format. Preparation and review of responses to authority questions during registration and product lifecycle. Keep track of assigned projects and follow-ups to ensure the Dossier is delivered as per set timeline/commitments. Designing, Reviewing & Approval of Artwork required for registration purposes. •Dossier due diligence for products being in-licensed from other company Support in preparing the meeting materials as needed, eg, regulatory project status/ submission/ approval information monthly, quarterly or yearly. Interested professionals may share their CVs to janihimanshu@alembic.co.in stating position code RA-MEXICO” in subject line

Role & responsibilities Job description Ensure that a company's products comply with the regulations of the regions. Keep up to date with national and international legislation, guidelines and customer practices Respond to queries from Centre for Veterinary Medicines (CVM). Collect, collate and evaluate scientific data from FR&D, AR&D and DQA. Develop and write clear arguments and explanations for new product licences and licence renewals at R&D site. Prepare submissions of licence variations and renewals to strict deadlines as per CVM. Monitor and set timelines for licence variations and renewal approvals Advise scientists (AR&D, FR&D, Pkg.-R&D) on regulatory requirements. Provide strategic advice to senior management throughout the development of a new product Review company practices and provide advice on changes to systems if any. Liaise with manager, and make presentations to, regulatory authorities, if any. Negotiate with regulatory authorities for marketing authorisation Take part in the development of marketing concepts and approve packaging and advertising before a product's release. Prepare the CTD sections of the dossier and ensure timely filing as informed by the functional head and Head -R&D. Review the data and check for its alignment and compliance from regulatory point of view as per CVM. Ensure the regulatory filing grid as shared by Functional head and Head-R&D is met on timely way and in complete regulatory compliance. Collaborate with FR&D, AR&D, Pkg-R&D on regular basis and together ensure the timely filing of products.

Role & responsibilities Contractual Role for 6 Months. Exploration of updated guidelines needed for dossier compilation for ROW market/ Regulated Market. Preparation, compilation, review, and submission of Pharmaceutical Dossiers to emerging market as per International Conference on Harmonization (ICH) and country specific guidelines in Common Technical Document (CTD), Asian Common Technical Document (ACTD) and regional format. Internal communication & follow-ups with various departments for various documents. To arrange and send samples for registration purpose to various countries. Review at all quality data received from various departments before using in dossiers and technical packages. Preparation and submission of Query response raised by the Health Authority. To undertake any other assignment given by superior of the department / management from time to time. To support in documentation in national and international tenders. Management of Product Database. Archival of dossier. For COPP Application- Support with documents. Preferred candidate profile Must be from Formulation background interested applicant can send CV on shital@mjbiopharm.com , janhavi.shedekar@mjbiopharm.com or contact on 9619744167. Perks and benefits

Job Description: Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per EAEU guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

Labour and Employment Law Legal Team Associate Manager / Manager Description About Entity: Corporate Functions"including Human Resources, Finance, Legal, Marketing Communications, and Workplace Solutions-- powers Accenture's people across industries and functions to keep our business leading in the New. Join the heart and soul of Accenture, partnering with our extraordinary people to bring innovation into every organization. Job description: Labour & Employment Counsel Associate Manager Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, Accenture offers Strategy and Consulting, Technology and Operations services and Accenture Song"all powered by the world's largest network of Advanced Technology and Intelligent Operations centres. Accenture India has operations in 14 cities across India and have more than 300k employees spread across these locations. Requirement: We are looking for 2 lawyer for position of Associate Manager (equivalent to a Deputy Manager in industry parlance) in the Employment Law (India) Legal Group Reporting will be to Senior Manager / Associate Director [Legal] Employment Law which is a part of Operations, Regulatory and Ethics (CORE) Legal, supports a broad portfolio and supports the Delivery Centres, in end-to-end operations. Internal clients range from Employee Relations, HR, Recruitment, Workplace, Global Asset Protection (GAP), Marketing and Communication (Marcom), and Government Relations. Role Description: This role is broad and could involve providing advice on various facets of legal and employment areas and demands an understanding of Indian labour laws, laws relating to investigations (misconduct, POSH and others), and court proceedings etc. Focus for the current position is as follows: Role Description: Advisory Services: Provide legal guidance on employment-related issues in India, including hiring practices, employment contracts, misconduct, discrimination, harassment, employee benefits, termination procedures etc. Proactively assess and mitigate employment legal risks. Employment Disputes and Litigation: Manage employment-related disputes, claims, and litigation in tribunals and courts, including wrongful termination, discrimination claims, and wage disputes. Collaborate with external legal counsel to strategize and achieve optimal outcomes. Legal Drafting: Prepare written statements and responses to claims, conduct comprehensive legal research to support case strategies, and stay abreast of recent case laws and legal precedents in labour and employment law. Sexual Harassment Law: Provide advice on matters related to the Prevention of Sexual Harassment (POSH) Act. Policy review: Collaborate with stakeholders to develop, review, and implement employment policies and procedures that comply with local laws and align with the organization's values. Regulatory Monitoring: Monitor changes in employment laws and regulations, assess their impact on the organization, and recommend proactive measures to ensure compliance and mitigate potential risks. Labour Compliance: Ensure adherence to labour laws and regulations, including the Shops and Establishments Act. Sexual Harassment Law: Provide advice on matters related to the Prevention of Sexual Harassment (POSH) Act. Key Skills: Review employee matters, analyse and asses possible and suggest mitigations measures. Court experience and proficiency in drafting legal documents and court submissions Strong legal research and analytical skills with in-depth knowledge of Indian labour laws and regulations Clear communication and interpersonal skills High attention to detail and exceptional organizational skills. Qualifications Education and Experience Requirements Required LLB 6 + years relevant work experience

Overview Shure is a global leader in professional audio electronics with a history of product innovation spanning over 90 years. The Shure Hyderabad location has been operational since June 2019. W e are looking for talented professionals who have experience in the SEZ compliance area. This position is a part of the Finance team at Shure India. Responsibilities Well versed with SEZ Rules , Regulations and customs regulation Should have exposure to de-bonding, Imports, DTA, Temporarily Removal of goods and other allied matters in SEZ Well versed of SEZ online portal Exposure to all compliances related to SEZ and STPI units viz., MPR, QPR, APR, Softex, Endorsement of Invoices, DSPF etc. Collation of details from relevant teams for preparation of returns/ submissions/ replies to SEZ STPI authorities for various units across India Responsible for representations/liaising with SEZ/STPI Authorities for various matters and obtain necessary approvals Assistance in audits Liasioning with Bankers for clearing the BOE’s Ensuring the invoices are in compliance with the SEZ norms Maintaining the documentation Maintaining the Fixed Asset Register Qualifications Bachelor’s Degree in Commerce or MBA with experience of working in multi national companies in similar role. Experience is minimum 3Years. WHO WE ARE. Shure’s mission is to be the most trusted audio brand worldwide – and for nearly a century, our Core Values have aligned us to be just that. Founded in 1925, we are a leading global manufacturer of audio equipment known for quality, reliability, and durability. We engineer microphones, headphones, wireless audio systems, conferencing systems, and more. And quality doesn’t stop at our products. Our talented teams strive for perfection and innovate every chance they get. We offer an Associate-first culture, flexible work arrangements, and opportunity for all. Shure is headquartered in United States. We have more than 35 regional sales offices, engineering hubs, and manufacturing facilities throughout the Americas, EMEA, and Asia. THE MIX MATTERS Don’t check off every box in the job requirements? No problem! We recognize that every professional journey is unique and are committed to providing an equitable candidate experience for all prospective Shure Associates. If you’re excited about this role, believe you’ve got the skills to be successful, and share our passion for creating an inclusive, diverse, equitable, and accessible work environment, then apply! #LI-HYBRID

Green Earth Exim India Pvt. Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Career County is looking for LEGAL EXECUTIVE 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.

Vital Healthcare Pvt. Ltd. is looking for Officer Regulatory Department to join our dynamic team and embark on a rewarding career journey. Oversee and manage daily operations within the assigned department Ensure compliance with company policies, industry regulations, and legal standards Prepare reports, maintain records, and handle documentation efficiently Coordinate with internal teams and external stakeholders for smooth workflow Address and resolve operational challenges to improve efficiency Monitor performance metrics and implement corrective actions when necessary Support senior management in decision-making and strategic planning

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

Job Title: Senior Executive Drug Regulatory Affairs (DRA) Job Responsibilities: Prepare and review regulatory dossiers in compliance with country-specific guidelines, including CTD, ACTD, and other regional formats. Manage dossier submissions for new registrations, re-registrations, and product variation filings. Review quality and administrative documents to ensure completeness and accuracy before submission. Conduct literature searches to compile non-clinical and clinical data for dossier preparation. Develop and review SmPCs, Package Inserts, and labeling information in accordance with regulatory requirements and initial dossier submissions. Evaluate and approve artwork for export products. Collaborate with cross-functional departments including QA, QC, Production, ADL, and R&D to streamline regulatory processes. Address and resolve queries from regulatory authorities such as the FDA and other relevant agencies. Maintain communication with international clients regarding dossiers, sample requirements, and regulatory updates. Draft and review applications for product permissions, COPPs, and FSCs. Market Exposure: ASEAN: Philippines, Vietnam, Myanmar, Laos, Cambodia, Thailand Africa: Uganda, Nigeria, Ethiopia, Mozambique, Tanzania, Cameroon, Ivory Coast, Benin, Burundi, Togo, Congo, ZaZiBoNa, South Africa LATAM: Peru, Ecuador, Bolivia, Guatemala, Nicaragua, Costa Rica CIS: Kyrgyzstan, Uzbekistan, Russia, Ukraine Other Regions: Georgia, Sri Lanka, Azerbaijan