231 Ctd Jobs - Page 2

NKP Pharma is looking for EXECUTIVE / ASSISTANT MANAGER (SALES) 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

Dear All, We are looking for a Regulatory Affairs Executive with 2-4 years of experience in pharmaceutical formulations, specifically for the ROW (Rest of World) market . Hands-on experience in the preparation and submission of regulatory dossiers in CTD and ACTD formats for Rest of the World (ROW) markets. Proficient in drafting and submitting responses to regulatory queries within stipulated timelines. Experienced in managing post-approval activities, including renewals and variations. Skilled in handling Drug Master File (DMF) notifications. Adept at reviewing and ensuring the accuracy and compliance of quality documents such as product specifications, stability data, Product Development Reports (PDR), Batch Manufacturing Records (BMR), Master Formula Cards (MFC), and process validation protocols. Interested candidates can share their resumes to raghuveera.vutla@aizant.com Note: Immediate Joiners are more preferable

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP for Oil & Gas Joint Venture Accounting Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activities, ensuring that solutions are effectively implemented across multiple teams, while maintaining a focus on quality and efficiency in application delivery. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure alignment with strategic goals. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP for Oil & Gas Joint Venture Accounting.- Strong understanding of financial accounting principles and practices.- Experience with application lifecycle management.- Ability to analyze and optimize business processes.- Familiarity with integration techniques for various applications. Additional Information:- The candidate should have minimum 12 years of experience in SAP for Oil & Gas Joint Venture Accounting.- This position is based at our Hyderabad office.- A 15 years full time education is required. Qualification 15 years full time education

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure project milestones are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also engage in strategic planning sessions to align project goals with organizational objectives, ensuring that the applications developed meet the needs of stakeholders and users alike. Your role will require you to balance technical oversight with team management, fostering an environment of innovation and collaboration. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure timely delivery of application features. Professional & Technical Skills: - Must To Have Skills: Proficiency in Lorenz docuBridge or other regulatory submission & publishing management system.- Experience in supporting Publishing applications- Experience in working in Lorenz docuBridge- Must have functional & technical skill in regulatory publishing systems.- Strong domain knowledge & understanding of application design principles and best practices.- Ability to troubleshoot and resolve technical issues effectively.- Familiarity with integration of Lorenz docuBridge with other enterprise systems. Additional Information:- The candidate should have minimum 5 years of experience in Lorenz docuBridge or similar document systesms.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank. The ideal candidate will have 2-3 years of experience in the BFSI industry, preferably with a background in risk management or a related field. Roles and Responsibility Conduct thorough analysis of customer data to identify potential risks and develop strategies to mitigate them. Collaborate with cross-functional teams to implement effective risk management plans and monitor their progress. Develop and maintain relationships with key stakeholders, including customers, vendors, and internal teams. Identify and assess new business opportunities and provide recommendations for growth and expansion. Stay up-to-date with industry trends and regulatory requirements to ensure compliance and minimize risk. Provide expert guidance on risk management best practices to junior team members. Job Requirements Strong understanding of risk management principles and practices, with a focus on asset management and risk containment. Excellent analytical and problem-solving skills, with the ability to interpret complex data sets and make informed decisions. Effective communication and interpersonal skills, enabling strong collaboration with diverse stakeholders. Ability to work independently and as part of a team, demonstrating a flexible and adaptable approach to changing priorities. Strong knowledge of financial regulations and industry standards, with a commitment to ongoing professional development. Proficiency in Microsoft Office and other relevant software applications, with excellent time management and organizational skills.

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Get feedback from all the countries for respective variation, and their timely submission. 7. renewals. 8. Master data Updating. 9. Follow ups with plant for documentation regularly and review meeting. Preferred candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products Must have exposure to in-licensed dossier filing and out licensing

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 10 years of experience in Formulations OSD 2. Willing to work in Chennai 3.Strong expertise in European, EMA, MHRA & other international regulatory framework 4.Knowledge of ICH & regulatory

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into project timelines and deliverables. Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements. Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions. Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed. Participate in internal and external audits and inspections related to regulatory compliance. Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation Qualifications Bachelors degree in a science, pharmacy, or a related field; advanced degree (e.g., Masters, PhD) preferred. Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry. Skills Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.

Original Application submission Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve outs based on patents and exclusivity claims Labeling Query responses/ REMS and Patent Amendments/ PNP Requests Thorough review/interpretation of FDA comments. Review of revised labeling and response. Tracking/ Review for Completeness/ Timely Submission of REMS correspondence/ Amendments Review of patent amendment & proprietary name review request Submission of Final Approval Requested Life Cycle Management Track RLD labeling changes Initiate labeling revision activity as per RLD label revision/safety labeling change SLC notification from FDA Submission of Labeling Supplements (CBE 0/ CBE 30/ PAS) Timely submission of REMS Review of revised artworks

Rama Super Speciality Hospital is looking for ENT Surgeon to join our dynamic team and embark on a rewarding career journeyExamining patients to diagnose and evaluate their medical conditions, including the use of diagnostic equipment and tests such as X-rays and MRI scans.Developing and implementing treatment plans, including the use of surgical procedures and other medical therapies.Performing surgical procedures to treat conditions such as ear infections, hearing loss, sinusitis, voice and speech disorders, sleep apnea, and head and neck tumors.Communicating with patients and their families, discussing diagnoses and treatments, and answering questions and concerns.Collaborating with other medical specialists, such as neurologists, audiologist, and speech therapists, to provide comprehensive patient care.Maintaining accurate and complete patient records, including medical history, exam results, diagnostic images, and treatment plans.Participating in continuing education programs and conferences to maintain and improve surgical skills and knowledge.Ensuring that all medical equipment is properly maintained and in compliance with safety regulations.

Role & responsibilities * Data Entry and Updation in Regulatory Information Management System. * Dossier preparation (New/ Renewal/ Variations) for different countries. * Other RA Related Activities. Perks and benefits * 5 days working Environment * Additional Benefits.

To ensure that products with all regulations and legislation, both National and international,throughout the product lifecycleThe RAP works closely with R&D manufacturing QA/QC and mkt to ensure timely registration,compliance and approval of products

Do you want to contribute to the future of healthcareAs Siemens Healthineers values those who dedicate their energy and passion to this cause, our company’s name is dedicated to our employees. It’s their pioneering spirit, blended with our long history of engineering in the ever-evolving healthcare industry that truly makes us unique as an employer. We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone to grow both personally and professionally. Sound interesting Then come in and join India team as Regulatory Affairs Specialist. Your tasks and responsibilities: Planning and preparing product related medical device submissions for the products manufactured at the Bangalore factory according to country specific regulatory requirements and maintaining of licensed products (e.g., for USA, EU, India, Latin America, Asia) Take responsibility for product / component registrations following respective standards such as BIS, AERB, CDSCO for the products used at the Bangalore factory You will provide professional advice to and actively support internal departments, such as product development in implementation and fulfillment of the applicable regulatory requirements (laws, guidelines, regulations) to ensure the registration of the products manufactured. Supporting the audits from the respective authorities of the different countries as a part of the product registration process Your qualifications and experience: You have a diploma or degree in engineering, or a comparable field of study with relevant knowledge of imaging procedures (e.g., radiography, fluoroscopy) and clinical interventional procedures You have 4-5 yrs of experience in medical device registration. You have knowledge of the pertinent regulatory frameworks of the EU, China, India, and Latin America. Experience regarding USA registrations would be beneficial You have professional experience in the regulatory affairs functions or in comparable positions in the medical device industry, and you are very familiar with relevant interfacing processes, such as product risk management, post-market surveillance, and product lifecycle management Your attributes and skills: You show a collaborative, inspiring working style, and you can accommodate different personalities in a functional team You have excellent written and spoken English communication skills You are a great communicator, collaborative, inspiring, and able to accommodate different personalities in a functional team You are experienced in working in a demanding environment, and you pursue the aligned strategic targets by prioritization, consolidation, and smart decision making We win togetheryou are a team player; you follow the Siemens Healthineers goals with dedication and passion for the job Our global team: We are a team of 68,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started. To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our job’s alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

: Job TitleOperations Expert, AS Location:Bangalore, India Role Description Overview: Deutsche Bank is committed to being the best financial services provider in the world, balancing passion with precision to deliver superior solutions for our clients. This is made possible by our peopleagile minds, able to see beyond the obvious and act effectively in an ever-changing global business landscape. As youll discover, our culture supports diverse perspectives, driven by a shared sense of purpose. Margin Operations responsible for minimizing Deutsche Banks counterparty credit risk on its collateralized derivatives portfolio. We aggregate the Banks exposure across trading activity globally, administer the margin terms dictated in bilateral ISDA and CSA (Credit Support Annex) Agreements and facilitate exchange of permissible collateral (cash or securities) with our clients or central clearing counterparties. The team also manages Margin Disputes, regulatory Portfolio Reconciliation and Data Control flowing into the margining systems for APAC, EMEA and US regions. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Ensure adherence to cut-off times and quality of processing as maintained in SLA. Provide superior service to internal and external stakeholders (incl. client and front office). Demonstrate importance of timely and accurate communication in a manner that is appropriate for that particular audience. Supervision of daily business processes, complete with adherence to standard tools and minimum requirements (e.g. Daily team huddles, end of day dashboards, daily supervisory checklists). Manage inward-outward escalations internally/externally to mitigate associated risks in the process. Keep Management informed of the exceptional occurrences, to enable appropriate action. Understand the impact of market trends on process flows. Develop effective working relationship across the front to back processes in multiple locations to enhance operating effectiveness. Your skills and experience Strong organisational skills; ability to identify and prioritise multiple tasks based on criticality, impact and franchise importance. Exceptional communication skills verbal, written and presentation. Independent problem solver who demonstrates analytical thinking, accountability as well as execution capability. Ability to independently coordinate and manage work requirements across multiple business areas and functions, think outside the box and connect with global stakeholders. Ability to work in a fast-paced, highly regulated environment. An outstanding team spirit and flexibility are key. Dedication to servicing a demanding internal and external client base with a high degree of accuracy. Professional Skills: Degree educated in Finance, Commerce or related field, or have a minimum of 6 years of work experience in a Banking/Finance environment. Experience working in a global, cross matrix reporting organization. Background in Collateral, Margin, Rates, Credit, FX, Securities, Treasury or Liquidity Management. Microsoft Excel skills to a good standard. Proficiency in automotive industry tools is beneficial. How well support you About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

RESPONSIBILITIES Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU and/or UK. Experience with AUS-NZ submissions would be an added advantage. Publishing in eCTD format and submission to respective Regulatory Agencies. Compilation and submission of variation applications for EU and/or UK. Review of documents related to compilation of dossiers, variations and query responses. Up to date knowledge of EU regulatory guidelines and requirements. DESIRED SKILLS Must have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycle Should have handled initial MAA submission & Variations for EU. Good technical knowledge with respect to solid oral dosage forms. Adept at review of manufacturing and analytical documentation from a regulatory perspective. Strong knowledge of CTD /eCTD requirements and hands-on experience with compilation of CTD modules 1 to 5 is mandatory. Hands on experience with portal submissions would be preferable. Ability to try new approaches when faced with challenges. Should have good analytical and learning attitude. Good communication (written and oral) and inter-personal skills.

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study. Experience Required: CDSCO , USFDA, EUGMP, NAFDAC Dosage Form Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

Responsible for overseeing al aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market. Developing and implementing comprehensive regulatory strategies for new drug development, including clinical trial design, data submission plans, and market access strategies. Leading the preparation and submission of regulatory dossiers to health authorities for new drug applications, variations, renewals, and post-market surveillance reports. Ensuring adherence to all applicable regulatory requirements, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and labelling regulations. Building and maintaining strong relationships with regulatory agencies, proactively addressing any concerns or queries regarding product submissions. Managing and developing a team of regulatory professionals, including regulatory affairs managers, specialists, and associates, ensuring their expertise is utilized effectively. Education: B Pharm/M Pharm with exposure in Regulatory Affairs for 15 to 20 years in pharma. Desirable Skills & Competencies: Deep understanding of global pharmaceutical regulations, including ICH guidelines and relevant regional regulations. Extensive experience in the drug development process, from pre-clinical to post-market surveillance. Proven leadership skills in managing and motivating a regulatory affairs team. Excellent communication, negotiation, and interpersonal skills to effectively interact with regulatory agencies and internal Stakeholders. Interested candidates can mail their updated resume & CTC on sumit.s@titanpharma.com. Thanks & Regards, Sumit Shirke HR Department Titan Laboratories Pvt Ltd

: Job Title CSO Environmental and Social Due Diligence & Sustainable Finance Manager LocationMumbai, India Corporate TitleAS Role Description The Chief Sustainability Office is responsible for developing Deutsche Banks sustainability strategy and driving its implementation across all business divisions, infrastructure functions, and regions. Its core responsibilities include defining the strategic framework, coordinating the Banks sustainable finance activities, setting ESG standards, and overseeing regulatory and disclosure obligations. It comprises four teams: Strategy & Regional Governance , Execution, Data & Regulatory , Group Sustainability , and ESG Transparency . Strategy & Regional Governance develops and coordinates the Groups sustainability strategy and governance. It supports the business divisions and cross-divisional business opportunities and coordinates the planning of the Banks Sustainable Finance targets. Execution, Data & Regulatory is responsible for implementing the Banks strategic sustainability objectives through the Sustainability Key Deliverable (KD) and also covers centrally managed non-KD implementation projects with an ESG nexus. In addition, it identifies and assesses ESG-related regulations, supports business divisions and functions in their implementation, collaborates with external stakeholders on regulatory ESG matters, and integrates technology, data, and innovation into sustainability-related data. Group Sustainability is tasked with establishing bank-wide standards and processes for environmental and social sustainability, including human rights. It controls and oversees the adherence to these standards, including enhanced environmental and social due diligence (ES), and oversees the classification of sustainable finance. ESG Transparency plays a key role in enhancing transparency regarding the Banks sustainability agenda and performance, as well as in fostering dialogue with key stakeholder groups. It develops and implements Deutsche Banks approach to assessing the materiality of sustainability topics and coordinates key ESG rating requests. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities As an Environmental and Social Due Diligence & Sustainable Finance Manager, you will be part of the Group Sustainabilit team within Deutsche Banks Chief Sustainability Office. In this role, you will be responsible for applying and further developing the group-wide frameworks for managing environmental and social (ES) risks in the banks core business, as well as for classifying transactions under Sustainable Finance (SF) criteria. Supporting environmental and social due diligence for new clients and transactions, as well as contributing to the classification of deals under the Sustainable Finance framework. Contributing to the development, implementation, and continuous improvement of related guidelines, processes, training programs, and control mechanisms. Preparing presentations, reports, and analyses on ES and SF topics for internal and external stakeholders. Raising awareness of environmental and social issues and associated risks, and delivering training sessions globally and within your region. You will support the engagement process with NGOs and rating agencies on environmental and social topics in India. Your skills and experience Minimum of 3 years of experience in a financial institution, investment bank, consultancy, or professional services firm, advising on sustainable practices, environmental, social, and governance (ESG) issues, and related regulations. At least 2 years of proven experience specifically in Environmental and Social (ES) and/or Sustainable Finance (SF), ideally with a focus on valuation or transaction analysis involving environmental and social considerations, aligned with internationally recognized standards (e.g., Equator Principles, IFC Performance Standards). Solid knowledge of current ESG regulations and guidelines, including Sustainable Finance frameworks. Minimum educational qualificationBachelors degree in Business Administration, Political Science, Natural Sciences, or a comparable field. Highly self-motivated and detail-oriented, with a strong sense of initiative and urgency, and the ability to manage multiple competing deadlines effectively. Comfortable working in an international role and dynamic, fast-paced environment, with a pragmatic, proactive, and solution-oriented mindset. How well support you

Industry: Payments/ Financial Services business Functional Area: Payments and Financial Services Role: Senior Manager Reporting to :Director Legal Key Skills: Drafting, vetting, and negotiating agreements, Providing legaladvice, Product counselling, Interpreting regulations and providing guidance to internal teams, Risk identification and Management. Experience: Minimum 10+years experience, including experience inPayments/ FinancialServices/ FinTech (required). Education University Degree in law. A Masters Degree in Law is not mandatory, but will be an added advantage. Location: Bangalore PRIMARY RESPONSIBILITIES : Business Reviewing existing products, as well as new products/ features, with the lens of ensuring they are in line with applicable laws and critical industry practices. Providing legal guidance to, and working closely with Compliance, Business and other stakeholders, in this regard. Drafting, reviewing, negotiating, and closing contracts (relating to the payments/ financial services business, banking contracts etc.) with the internal and external stakeholders, with a view to protect the organization against any legal exposure and to minimize liability. Provision of legal advice in framing/ review of policies, and other internal and external documents. Staying updated on the regulatory environment; identify, interpret, and analyse existing and new legislations/ amendments/ notifications that may impact business; and basis its applicability and implications, bring it to the notice of appropriate internal functions as required. Advise and assist all stakeholders including Compliance and Business on both, ongoing legal risks and anticipated/ new legal risks arising by virtue of new laws or regulations. Internal process Adhere to timelines in reviewing and vetting all documentations, including agreements. Follow up with internal stakeholders, including business leads,for time bound closure of agreements;provide advice in course corrections; escalate when required. Monitor the timelines for submission of applications pertaining to licences (new and renewals) to regulatory authorities and ensure timely escalation where required. Learning Maintain a database on applicable laws comprising FAQs, dos anddontsas a ready reference. Keep a track on the latest lawsand notifications (including all notifications issued by the RBI), and proactively advise the management and business about such laws/ amendments and its implication on business, and accordingly suggest changes in process/ procedure. PhonePe Full Time Employee Benefits (Not applicable for Intern or Contract Roles) Insurance Benefits - Medical Insurance, Critical Illness Insurance, Accidental Insurance, Life Insurance Wellness Program - Employee Assistance Program, Onsite Medical Center, Emergency Support System Parental Support - Maternity Benefit, Paternity Benefit Program, Adoption Assistance Program, Day-care Support Program Mobility Benefits - Relocation benefits, Transfer Support Policy, Travel Policy Retirement Benefits - Employee PF Contribution, Flexible PF Contribution, Gratuity, NPS, Leave Encashment Other Benefits - Higher Education Assistance, Car Lease, Salary Advance Policy Working at PhonePe is a rewarding experience! Great people, a work environment that thrives on creativity, the opportunity to take on roles beyond a defined job description are just some of the reasons you should work with us. Read more about PhonePe on our blog. Life at PhonePe PhonePe in the news

Role & responsibilities 1. Prepare, compile, and review regulatory dossiers for submission. 2. Respond to queries and deficiency letters from regulatory authorities in coordination with technical teams. 3. Co-ordinating with cross-functional teams like R&D, QA/QC, production to collection of data for submissions. 4. Maintain regulatory files and track submission and approval status using internal systems. 5. Provide regulatory input during product development, scale-up, and lifecycle management. 6. Supporting the review of product labels, cartons, and inserts to ensure compliance with regulations. 7. Ensure products comply with all regulatory requirements through each stage of development and commercialization. 8. Conduct training sessions on regulatory updates and internal System 9. Ensure documentation is audit-ready and aligned with internal SOPs and regulatory expectations. 10. Support internal and external audits by providing required regulatory documents and justifications. 11. Guide and review work of junior team members or trainees. 12. Review and interpret regulatory guidelines and notify stakeholders of relevant updates. 13. Review of all dossiers related technical documents Preferred candidate profile Experience in reviewing of Analytical documents

Planning, review & submission of CTD/ACTD/eCTD for export market (Markets will work for Europe / US). Registration/Re-registration/post approval changes application for export market. Resolve the technical query related to product registration/Re-registration/post approval changes. Follow-up and coordination with internal stakeholders. Review of technical documents. Review of artwork and pack insert. Preparation and submission of Product safety update report.

Preparation of DMFs for different markets in CTD and eCTD formats. Coordination with cross-functional dept to manage the documents. Supporting marketing team & QC/QA/R&D in various capacity. Preparation of Declarations and other supporting docs. Perks and benefits PF CANTEEN TRANSPORTATION

Privacy and Data Protection Director LocationIndia (preferably Bangalore) Experience - 16+ yrs Role dimension The Wipro Privacy and AI Governance Team is a dynamic group committed to maintaining the highest standards in privacy, data protection, AI governance and ethics. We operate at the forefront of these critical fields, ensuring that our practices align with both legal standards and technological advancements. We are seeking a dedicated and experienced professional to join our team as a Privacy and Data Protection Director. Job Summary As Privacy and Data Protection Director, you will play a pivotal role in embodying our privacy and data protection strategies across the organisation. Your expertise will be critical in elevating the organisations privacy maturity, providing timely expert advice, enhancing internal procedures, flows and practices, enhancing team capabilities through training, and refining internal processes. You will serve as a trusted advisor, ensuring that our operations are compliant with legal requirements while leveraging technology effectively. You will also lead on transforming our privacy operations through streamlining, automation and efficiency. Key Responsibilities Trusted Strategic AdvisorLead the elevation of organizations privacy maturity and compliance posture, and act as the primary point of contact for privacy-related matters, providing expert guidance to various business units and stakeholders within the team and the wider organisation. Operations enhancement and automationDirect the review and operationalization of policies, processes to ensure they are current, relevant, and effective in evaluating privacy and AI related risks. Identify opportunities for streamlining and automating existing pathways. Team UpskillingDesign and implement training programs that enhance the team's understanding of privacy and data protection, specifically within the context of artificial intelligence and new technologies. Process ImprovementAnalyse existing internal processes and procedures related to privacy and data governance, identifying areas for improvement and leading initiatives for upgrade and compliance. Legal and Technology IntegrationServe as an innovative voice for the privacy function at the intersection of legal frameworks and technological developments, ensuring that our operations reflect both. Stakeholder EngagementCollaborate with cross-functional teams to ensure privacy considerations are integrated into business strategies, product development, and operational practices. Monitoring and ComplianceLead the development and implementation of privacy compliance initiatives, ensuring alignment with relevant regulations and frameworks. Qualifications: Proven experience in privacy and data protection roles in a senior capacity, whether as a privacy lawyer, head of privacy, senior risk professional or similar. Strong working knowledge of privacy laws and regulations, including GDPR, CCPA, PDPD and others relevant to our operational geographies. Experience in governance, risk management, and compliance within technology-driven environments, particularly relating to AI. Exceptional communication and interpersonal skills, with the ability to influence at all levels. Demonstrated ability to manage projects effectively and work collaboratively in a fast-paced environment. Advanced degree in law, information management, security or a related field is preferred. Why Join us At Wipro, you will be part of an innovative team at the forefront of privacy and AI governance. We value diversity, collaboration, and the growth of our employees. You will have the opportunity to impact how we approach privacy in a technologically evolving landscape, establishing standards that not only comply with regulations but also inspire trust in our clients and partners. Applications from people with disabilities are explicitly welcome.

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.

Manager Mobility Industrial Join our team in Strategy & Consulting to find endless opportunities and solve our clients' toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Transportation and Logistics, Industrial Consulting, S&C Global Network (GN) I Areas of Work: Mobility & Transport Solutions| Level: Manager | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad | Explore an Exciting Career at Accenture Are you a problem solver driven by impactful resultsDo you enjoy working on transformation strategies for global clientsDoes a collaborative and inclusive workplace energize you Then, Accenture Strategy & Consulting is where your potential can reach new heights. The Practice A brief Sketch Transportation and Logistics team within S&C GN Industrial Practice brings extensive expertise in driving operational efficiency and digital transformation across global mobility ecosystems. We specialize in digital transformations, end-to-end supply chain optimization, freight and fleet management, route planning and optimization, transportation management systems (TMS) implementation, mobility-as-a-service (MaaS), shared & autonomous mobility services, asset management, process automation and digitization, sustainability initiatives, advanced analytics and data-driven insights, IoT and asset tracking solutions, and industry benchmarking and best practices. Our approach leverages advanced technology to optimize logistics operations, reduce costs, and enhance customer satisfaction, positioning our clients at the forefront of the logistics and transportation industry. Globally, Accenture helps our clients crafting robust transport strategies, driving operational efficiencies, and achieving sustainability goals in logistics. We work on a range of projects, from long-term transformational system integration to short-term agile engagements, supporting our clients with: Mobility Strategy and Transformation: Work with clients to define the vision and roadmap for the future of mobility, focusing on on-demand services, shared & autonomous mobility models, and the seamless integration of mobility services through MaaS platforms. Smart Stations and Terminals Ideation: Lead efforts in designing and developing smart infrastructure solutions for both rail and multimodal hubs that incorporate IoT, digital ticketing, and predictive analytics to improve efficiency, customer experience, and sustainability Enhance Customer Experience: Help clients develop and deploy autonomous rail technologies, on-demand mobility services, multimodal transport systems (e.g., buses, ferries, rail), and high-speed rail systems that enhance flexibility, accessibility, and speed, while improving overall passenger satisfaction and reducing congestion Fleet Electrification: Accelerating adoption of sustainable, electric-powered fleets for various modes of transport including buses and rails, ensuring compliance with environmental regulations Sustainability Mobility :Partner with clients to transition fleets to electric-powered systems, implement energy-efficient routes, and support the adoption of sustainable practices that reduce carbon emissions and ensure compliance with evolving environmental regulations Bring your best skills forward to excel in the role: Skills in one or more of the following areas: Urban Mobility Expertise: In-depth knowledge of multi-modal transport systems (rail, bus, ferry), including high-speed rails, fleet electrification, and shared & autonomous mobility services. Mobility-as-a-Service (MaaS): Experience in integrating on-demand mobility services into existing transport infrastructures, creating seamless connections between multiple modes of transport. Fleet Electrification: Expertise in transitioning fleets (buses, rail) to electric systems, optimizing energy consumption, and reducing emissions. Smart Infrastructure: Knowledge in designing smart infrastructure solutions, smart stations, and bus/ ferry/ air terminals that incorporate the latest digital technologies to enhance efficiency and improve passenger experience. Autonomous and On-Demand Mobility Solutions: Familiarity with the integration of autonomous vehicles and on-demand rail services within existing mobility networks. Sustainability and Green Mobility: Strong understanding of sustainable practices in the rail sector and knowledge of how to implement green mobility strategies in line with industry standards and regulations. Advanced Analytics and IoT Solutions: Ability to leverage IoT, predictive analytics, and data-driven insights to optimize transport operations and asset management. Other required skills: Leadership and Team Development - Ability to lead, mentor, and develop teams, fostering collaboration and creating an environment of growth and continuous learning Stakeholder Management - Manage mid-level to senior client leadership and lead conversations Communication and Presentation - Plan and deliver well-structured oral and written communications Structured Problem Solving - Help identify and structure key client challenges into hypotheses and conduct analyses to address the challenges Program management skill with an ability to coordinate cross-functional teams, manage project timelines, and drive successful delivery within scope and budget Cross-cultural competence with an ability to thrive in a dynamic environment Your experience counts! MBA from a Tier 1 or Tier 2 school, or extensive industry experience in mobility services or consulting. 8+ years of progressive experience in mobility solutions, fleet electrification, and MaaS integration. Experience with smart infrstructure, autonomous mobility, and on-demand services. Certifications in Project Management (e.g., PMP, Prince2) and Agile methodologies are an advantage. Familiarity with Agile practices (e.g., Scrum, Kanban) and tools like JIRA to manage projects effectively. Experience in strategy and business/technology consulting role conversant with process improvement, cost optimization, customer analytics and experience management etc. Experience in value architecting, business case preparation, value realization Experience in Digital, New IT, Cloud & Core modernization, Cloud transformation processes, transforming legacy to the cloud, Agile transformation, RPA, AI/ML strategy implementation and use cases Knowledge of design thinking workshops and innovation Experience in large data analysis, data driven consulting, BI and analytics, reporting, dashboarding, visualization tools like PowerBI, Tableau For Experienced candidates, experience of team Management Coach and mentor team members in projects, on asset development, BDs and overall professional development Whats in it for you An opportunity to work on transformative projects with key G2000 clients Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers, and communities. This is our unique differentiator. S&C Global Network (GN) a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our S&C Global Network (GN) teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world. come and be a part of our team. Qualification Years of Exp: 8+ years