183 Ra Jobs - Page 2

About the Role: Grade Level (for internal use): 10 About the Role: EMEA Benefits Specialist The Team: The Global Benefits Team is a team of specialists that focuses on the Wellbeing and Benefits for our colleagues across the globe supporting 40+ countries. The Impact We invest in our success as a company by investing in our people. At S&P Global, we are committed to comprehensive, competitive benefits for our people. We provide benefits to support the health and financial needs of our people while helping make their working life experience more rewarding. This is a critical role that touches each of our colleagues and is critical to our People First Philosophy. This role supports the wellbeing needs of our people while helping make their working life experience more rewarding. Whats in it for you To grow with a global company and learn more about key global benefits initiatives around the world. S&P Global puts our people first, and you will have the opportunity to participate in making positive change through global programs such as Wellbeing Reimbursement, Global Education, Global Parental Leave, Flexible Time Off program, Global EAP, Insured and Retirement benefits in the EMEA region. Responsibilities Manage benefits administration, renewals and day-to-day operations Support benefits programs involving the research and implementation of plans and programs as well as managing competitive benefits offered in the APAC region Subject matter expert for all benefits queries and escalations while also providing guidance and support to various business units Work closely with the external vendors, local leadership of the respective countries, HR partners, and other functions to offer best in class benefits and service to our employees Support APAC benefits projects and implementation related projects from beginning to end including benefits communication creation Develop and maintain policies and other documentation to educate all employees about the companys benefits programs. You'll be asked to work from office 2 days a week. What Were Looking For: Basic Required Qualifications: 4 years' minimum benefits experience Fluent English Exposure to managing benefits plans including benefits related regulatory and tax requirements Benefits project management skills. Capable of managing multiple tasks in an organized manner whilst interacting with various external and internal stakeholders Ability to engage and communicate effectively with employees and stakeholders while understanding their needs Microsoft Excel and PowerPoint experience. A self-starter that is motivated to achieve results whilst also being a team player Accurate, with great attention to detail A positive, flexible and proactive approach Additional Preferred Qualifications: German or French language will be beneficial Bachelor's degree desirable Workday knowledge is a plus If you meet the above qualifications and are passionate about designing and managing employee benefit programs, we would love to hear from you. Return to Work Have you taken time out for caring responsibilities and are now looking to return to workAs part of our Return to Work initiative, Restart, we are encouraging enthusiastic and talented returners to apply, and will actively support your return to the workplace. Whats In It For You Our Purpose: Progress is not a self-starter. It requires a catalyst to be set in motion. Information, imagination, people, technologythe right combination can unlock possibility and change the world.Our world is in transition and getting more complex by the day. We push past expected observations and seek out new levels of understanding so that we can help companies, governments and individuals make an impact on tomorrow. At S&P Global we transform data into Essential Intelligence, pinpointing risks and opening possibilities. We Accelerate Progress. Our People: Our Values: Integrity, Discovery, Partnership At S&P Global, we focus on Powering Global Markets. Throughout our history, the world's leading organizations have relied on us for the Essential Intelligence they need to make confident decisions about the road ahead. We start with a foundation of integrity in all we do, bring a spirit of discovery to our work, and collaborate in close partnership with each other and our customers to achieve shared goals. Benefits: We take care of you, so you cantake care of business. We care about our people. Thats why we provide everything youand your careerneed to thrive at S&P Global. Health & WellnessHealth care coverage designed for the mind and body. Continuous LearningAccess a wealth of resources to grow your career and learn valuable new skills. Invest in Your FutureSecure your financial future through competitive pay, retirement planning, a continuing education program with a company-matched student loan contribution, and financial wellness programs. Family Friendly PerksIts not just about you. S&P Global has perks for your partners and little ones, too, with some best-in class benefits for families. Beyond the BasicsFrom retail discounts to referral incentive awardssmall perks can make a big difference. For more information on benefits by country visithttps://spgbenefits.com/benefit-summaries Global Hiring and Opportunity at S&P Global: At S&P Global, we are committed to fostering a connected andengaged workplace where all individuals have access to opportunities based on their skills, experience, and contributions. Our hiring practices emphasize fairness, transparency, and merit, ensuring that we attract and retain top talent. By valuing different perspectives and promoting a culture of respect and collaboration, we drive innovation and power global markets. Recruitment Fraud Alert If you receive an email from a spglobalind.com domain or any other regionally based domains, it is a scam and should be reported to reportfraud@spglobal.com. S&P Global never requires any candidate to pay money for job applications, interviews, offer letters, pre-employment training or for equipment/delivery of equipment. Stay informed and protect yourself from recruitment fraud by reviewing our guidelines, fraudulent domains, and how to report suspicious activity here. ---- Equal Opportunity Employer S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment. If you need an accommodation during the application process due to a disability, please send an email to EEO.Compliance@spglobal.com and your request will be forwarded to the appropriate person. US Candidates Only The EEO is the Law Poster http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf describes discrimination protections under federal law. Pay Transparency Nondiscrimination Provision - https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf ---- HUMRES202.1 - Middle Professional Tier I (EEO Job Group)

We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .

How to Apply: Interested candidates are encouraged to send their updated CV via email or get in touch with us directly: Email: aratib@itm.edu Contact: Arati 88794 19086 Location: Kharghar, Navi Mumbai Organization: ITM Group of Institutions (www.itm.edu) Are you passionate about academic research and higher education? ITM Group of Institutions is inviting applications for the position of Research Associate to join our vibrant academic team in Kharghar, Navi Mumbai. Benefits: 3 Paid Leaves Every Month Provident Fund (PF) Mediclaim Coverage Gratuity Benefits Job Role: Coordination with students for resolving their queries. Managing certification programs coordination Arranging guest faculties for lectures/seminars. Plan & Organize industry visits for BBA Students Liaisoning with placement department Managing Alumni relations and their database Assisting senior faculties on research and managing all departmental tasks & events. Coordinating with students for projects & live assignments. Facilitating required training for RA's to be Faculty in BBA Department Willing to travel as and when required.

Company: Leeford Healthcare Ltd. https://www.leeford.in/ Position: Asst. Manager / Manager - Drug Regulatory Affairs (Domestic Market) Job location: Ludhiana Experience : 6 yrs above Job Profile: Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations. Handling and responding to all the product specific queries. Performing Root cause and analysis and preparing replies to the show cause notices Ensuring overall compliance with domestic regulatory requirements. Co-ordination with respective departments. Maintaining familiarity with company product ranges. Keeping up to date with changes in regulatory legislation and guidelines. Ensuring that quality standards are met and submissions meet strict deadlines. Maintain high levels of accuracy, meet tight deadlines. Management of Data. Required Candidate profile Candidate should have min 6 yrs. of experience in Regulatory Affairs Experience in Domestic Markets. Candidate should be well versed with Drug Regulatory Compliances. Can handle or manage a team. Candidates should be able to review artworks related to Drugs. Candidate should have good knowledge about Legal Metrology regulations. Kindly note we are looking candidate who can join on immediate basis. Interested one can share resume to talent@leeford.in or can whatsapp to 9875961129

Company: Leeford Healthcare Ltd. https://www.leeford.in/ Position: Asst. Manager / Manager - Drug Regulatory Affairs (Domestic Market) Job location: Ludhiana Experience : 6 yrs above Job Profile: Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations. Handling and responding to all the product specific queries. Performing Root cause and analysis and preparing replies to the show cause notices Ensuring overall compliance with domestic regulatory requirements. Co-ordination with respective departments. Maintaining familiarity with company product ranges. Keeping up to date with changes in regulatory legislation and guidelines. Ensuring that quality standards are met and submissions meet strict deadlines. Maintain high levels of accuracy, meet tight deadlines. Management of Data. Required Candidate profile Candidate should have min 6 yrs. of experience in Regulatory Affairs Experience in Domestic Markets. Candidate should be well versed with Drug Regulatory Compliances. Can handle or manage a team. Candidates should be able to review artworks related to Drugs. Candidate should have good knowledge about Legal Metrology regulations. Kindly note we are looking candidate who can join on immediate basis. Interested one can share resume to talent@leeford.in or can whatsapp to 9875961129

Company: Leeford Healthcare Ltd. https://www.leeford.in/ Position: Asst. Manager / Manager - Drug Regulatory Affairs (Domestic Market) Job location: Ludhiana Experience : 6 yrs above Job Profile: Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations. Handling and responding to all the product specific queries. Performing Root cause and analysis and preparing replies to the show cause notices Ensuring overall compliance with domestic regulatory requirements. Co-ordination with respective departments. Maintaining familiarity with company product ranges. Keeping up to date with changes in regulatory legislation and guidelines. Ensuring that quality standards are met and submissions meet strict deadlines. Maintain high levels of accuracy, meet tight deadlines. Management of Data. Required Candidate profile Candidate should have min 6 yrs. of experience in Regulatory Affairs Experience in Domestic Markets. Candidate should be well versed with Drug Regulatory Compliances. Can handle or manage a team. Candidates should be able to review artworks related to Drugs. Candidate should have good knowledge about Legal Metrology regulations. Kindly note we are looking candidate who can join on immediate basis. Interested one can share resume to talent@leeford.in or can whatsapp to 9875961129

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

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

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

Preparation of RA Bills and getting it certified with concern Project Management Consultants & Cost Consultants Team. Responsible for study of BOQ (Bill of Quantity) as per specifications and taking out quantities from drawings Identification and preparation of extra items and coordination with procurement department To coordinate with account team for invoice preparation and bank guarantee Billing, Measurement & Reconciliation Reconciliation of material & bill checking as per the joint service measurement To verify the quantities of materials purchased as per Drawing. Reconciliation of materials as per bill & site inward challans. Preparation of Handing over Documents & Billing documents. Preparation of as build drawing as per site execution. To ensure recovery against the rework / faulty work from the contractors as per recommendation from site Maintaining of all important documentation Ensures that Company policies and project procedures in terms of billing are being adhered to All jobs as assigned by MD Qualification & Preferred Skills: BE/Diploma Electrical with 3-5 years of experience Excellent communication skill Teamwork & Leadership skills preferred IT Skills MS Excel, Word, Powerpoint. Familiarity with Google Workspace is preferred. Excellent in organising & documentation skills Employment Type: Full Time, Permanent

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.

Job Summary: We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing pharmaceutical products across ROW & regulated markets. Key Responsibilities Regulatory Strategy & Compliance: • Coordinate with agents, partners, and MOHs to define submission strategies. • Prepare internal strategy documents and lead regulatory discussions for new products. Dossier Management & Submissions: • Manage CTD/ACTD/eCTD submissions for new registrations, renewals, and variations. • Ensure dossiers and query responses are complete and compliant. • Coordinate with plants for registration samples and related documentation. Stakeholder Collaboration: • Work with internal teams and external partners to gather and finalize technical documents. Regulatory Operations Oversight: • Compile and submit responses to MOH/partner queries on time. • Track regulatory submissions as per calendar. • Oversee renewals of FDA licenses, WHO GMP, COPPs, etc. Training & Regulatory Intelligence: • Conduct training on updated guidelines. • Share critical regulatory updates with teams. Documentation & Reporting: • Review technical and administrative dossier sections. • Maintain monthly regulatory status reports. • Coordinate site registrations and pre-audit activities. Leadership & Team Development: • Guide the RA team for efficiency and compliance. • Promote process improvements and regulatory best practices. • Handle additional tasks under the RA function. neetij@selectsourceintl.com

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.

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

To maintain and control overall QMS documentation. To monitor the compliance of standard operating procedure of all departments. Responsible to handling of FDA and certification works in absence of

Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA

Role & responsibilities Custodian of the packaging design and layout for all products Provides relevant source data for the Change Order/ Change Awareness notification Annotate the PDFs as per the respective Regulatory source content (word format) Clarify on need basis with the respective stakeholders, i.e. Labelling Lead, Artwork Coordinator, Market or Site Adherence to GSK artwork production standards and Standard Operating Procedures Identifies and engages other individuals who need to be involved in the review and approval of a Change Order, in accordance with any local procedures and requirements Participates in the review of the change on its viability on behalf of the market For changes initiated by the site: Reviews comments and authorizes the Change if required Ensures all critical checks have been carried out in accordance with the artwork checklist Approves the Change, referring to Regulatory Approved Labelling in Country Prescribing Information / Local Datasheet from Regulatory Vault Reviews and approves the new artwork in the Change Order(s) against Regulatory Approved Labelling in Country Prescribing Information /Local Datasheet and any supporting documents Responsible to re-prioritise the changes based on the business requirements Co-ordinates market activities/approvals as necessary throughout the lifetime of the change Ensure that all design and readability guidelines are adhered to across the full range of packs. Checks and confirms that artwork created matches authorized briefs / change orders covering multiple types of pack components, languages and formats To ensure that the relevant markets and sites approve the artworks prior to the Global Labelling approval or where acting on behalf of the LoC approve the change in line with the project and schedule requirements Adherence to regulatory and quality compliance requirements Adherence to agreed schedules for artwork production Be part of weekly Planning meetings to understand upcoming changes Responsible for working with Leads/Operations Manager to identify issues and resolve accordingly Responsible for maintaining high standards and working within agreed service level agreements Ensures that data integrity and accuracy is maintained throughout the proof-reading (review of the artworks) / amendment stages Implements the principles of Operational Excellence and Lean Sigma to recommend and bring about continuous improvement Monitors progress of artwork creation and ensures delays or issues are rectified or escalated to the appropriate level of management, and customers are kept informed of progress Ensure delivery of PBRERs, Addendum to clinical Overview (ACOs) and Line Listings are delivered as per the schedule Preferred candidate profile

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products Collaboration with partners to develop and execute global regulatory activities DMF preparations, review of changes and routine updates to Global Regulatory Agencies Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements Provide regulatory direction on global regulatory requirements to support product development Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle Support development and execution of clinical/non-clinical strategies Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans With minimal supervision, participate in development of risk management and contingency planning Ensure and lead regulatory compliance for biosimilar products Participation in regulatory meetings with Health Authorities Regulatory Intelligence: Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products Review and assess impact of regulatory decisions for competitive products Generate and communicate biosimilar intelligence Collaboration: Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products Identify process needs to meet internal challenges Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and Skills Comprehensive understanding of Regulatory activities Regulatory experience with product filings Team skills, especially in working with internal and external partners Familiarity with project management requirements Ability to understand and communicate scientific CMC information Anticipate and prevent potential issues Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission Education Doctorate degree OR Master's degree

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services. Employees under this span will be a part of one of the sub-offerings - 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 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. Veeva Regulatory Suite experienceCollect, 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 ServicesAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamLife Sciences Automation Enablement 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 Qualification Master of Pharmacy

Apollo Pipes Ltd is looking for Area Sales Manager - Rajkot 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

Quality Assurance: Develop and implement quality assurance policies and procedures for the manufacturing plant. Monitor and inspect raw materials, in-process production, and finished goods to ensure compliance with company quality standards. Conduct regular audits and inspections to identify potential issues and ensure adherence to quality control protocols. Process Improvement: Collaborate with cross-functional teams to identify areas of improvement in the manufacturing process. Analyze production data, identify trends, and recommend corrective actions to enhance product quality and process efficiency. Implement continuous improvement initiatives to reduce defects, waste, and production downtime. Compliance and Regulatory Standards: Ensure that the manufacturing plant complies with all relevant industry standards, regulations, and quality certifications. Keep abreast of changes in quality requirements and communicate updates to the relevant teams.

Job Description Overall Single Point of Contact for Quality IT Projects (such as LIMS, Chromatography, QAMS, EDMS, LMS etc.) Finalization of URS in alignment with sites (India + Global). Harmonization of system and processes in line with regulatory requirements and compliances. Testing and Validation of IT applications in line with URS for QA/ QC/ Common applications. Keeping organization up to date on the requirement for smart QA/ QC. Defining SOP and training of personnel. Supporting operational team. Keeping senior management updated on the organization status. Keeping senior management updated on the organization status. Facing Regulatory Audits at site as and when required. Keeping sites ready for all time audits. Work Experience 18 to 20 Years Education Post Graduation Masters in Science Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation 6. Process Excellence 7. Collaboration 8. Stakeholder Management Budgets/Cost Control