1260 Regulatory Affairs Jobs - Page 3

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug saftey associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug Safety AssociateDrug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

About the Role: Leap Scholar is a one-stop platform for any aspirant wishing to study abroad. It is a transaction platform for students to apply to the university of choice. The charter for this role will include: Conduct online telephonic and/or virtual counselling sessions with students interested in studying abroad Guide students on what courses to opt for based on their profile and interest Assist students on deciding on the universities/colleges and programs to opt for Assist in preparing and filing of their applications Guiding students on the visa process and visa applications Participate in educational activities such as exhibitions and events as and when required Ideal Persona would : 1+ years of experience in counselling students on admissions to universities and colleges in the UK, USA, Canada, Australia, Germany, NZ, Europe. Understanding of various courses and career options across various disciplines Experience of guiding students on the best course option based on the students profile and career interests Sound understanding of the admission process for Diploma, Bachelors, Post-Graduation diploma, and Masters degrees in the USA, UK, or Canada. If you have the skills and experience required for this position and are passionate about international education, we encourage you to apply.

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Contract Management Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Contract Lifecycle Management (CLM) Subject Matter Expert (SME) is someone with deep knowledge and experience in using CobbleStone's Contract Insight software to manage the entire contract lifecycle. This includes tasks like contract requests, authoring, negotiation, approval, execution, management, and renewal. They understand the system's features, configurations, and integrations, and can guide others in leveraging it effectively. Must have skills:3+ years of Cobblestone or similar Conract life cycle management tool hands on experience High analytical skills to understand and implement the requirementsGood communication and ability to handle client and cross team communications independently and effectively Ability to create meaningful requirement and status documentation in client specific formatFunctional testing knowledge Good to have:Certification in cobblestone or IcertisHealthcare Domain knowledge 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 : Contract Management Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Contract Lifecycle Management (CLM) Subject Matter Expert (SME) is someone with deep knowledge and experience in using CobbleStone's Contract Insight software to manage the entire contract lifecycle. This includes tasks like contract requests, authoring, negotiation, approval, execution, management, and renewal. They understand the system's features, configurations, and integrations, and can guide others in leveraging it effectively. Must have skills:3+ years of Cobblestone or similar Conract life cycle management tool hands on experience High analytical skills to understand and implement the requirementsGood communication and ability to handle client and cross team communications independently and effectively Ability to create meaningful requirement and status documentation in client specific formatFunctional testing knowledge Good to have:Certification in cobblestone or IcertisHealthcare Domain knowledge Qualification 15 years full time education

Job title: Regulatory Affairs Advisor Location: Global Flexible World-changing careers, enabled by Johnson Matthey. With more than 200 years history, join us and help to accelerate the transition to net-zero! As a Regulatory Affairs Advisor, working as part of the Product Stewardship and Sustainability team, you ll contribute to JM s mission as a world leader in sustainable technology, transforming energy and reducing carbon emissions for a cleaner, brighter future. The role: As a Regulatory Affairs Advisor, you will help drive our goals by: Supporting the delivery of robust regulatory affairs services to the Catalyst Technologies business, as part of a newly formed Catalyst Technologies Product Stewardship function, to meet business requirements in line with service delivery expectations. Create, maintain and update specialist regulatory hazard communication information (safety data sheets and product labels) to ensure compliance with global regulatory requirements and identify opportunities for product improvements Provide regulatory support to technical, commercial, and manufacturing functions to ensure the timely and compliant introduction of New Products and Technologies, thus enabling sustainable business growth. Manage all relevant supply chain communication (customers and business units) to provide timely and transparent delivery of regulatory compliance for raw materials, intermediates and finished products. Review and interpret regulatory information from registration dossiers/Chemical Safety Reports, and ensure relevant data are entered into the Safety Data Sheet system and communicated via SDS Carry out product notification, registrations, EU Classification & Labelling Inventory notifications and Poison Centre notifications. Key skills that will help you succeed in this role : Experience in authoring safety data sheets and labels according to requisite chemical legislation worldwide, using a recognized global regulatory system (ideally Sphera/Atrion) In depth knowledge of global chemical hazard classification, labelling and packaging legislation (GHS, CLP), REACH and global equivalents, Waste, COMAH, Poison Centres, etc. Degree or equivalent in a scientific subject e.g. chemistry, biochemical sciences, environmental sciences etc. Be able to work flexibly in a matrix organization and deliver high impact, actionable insight. Proficient written and spoken English communication skills Even if you only match some of the skills, we d love to hear from you to discuss further! What we offer: We make sure salaries are fair, competitive and aligned to individual roles, experience and responsibilities. We are also supportive of hybrid and flexible working and where applicable, offer life, medical and other benefits that support our employees financial and physical wellbeing, such as: Retirement savings Saving accounts Life and disability insurance Commuter allowances and loans Medical plans / health assessments Fitness discounts Ready to make a meaningful impact on your career and the environment? Join us and help shape a sustainable future while advancing your career! At JM, inclusivity is central to our values. We create an environment where everyone can thrive, embracing diverse perspectives to tackle challenges and ensure all colleagues feel valued and connected. For . We will work with you to make suitable adjustments at any stage of the recruitment process. All conversations are confidential, and your feedback is welcome to help us provide an accessible and positive recruitment experience. Closing date for applications: This job advertisement will be posted for a minimum of 2 weeks, early application is advised . #LI-DL1 To submit your application, please click the "Apply" button online. All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Johnson Matthey for the selection of suitable candidates for our vacancies as they arise. Johnson Matthey respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice: Johnson Matthey Privacy Notice . By applying for this role and creating an account you are agreeing to the notice. Johnson Matthey Plc is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.

Job Summary: Responsible for overseeing quality control activities for soap, fatty acid, and cosmetic products, ensuring compliance with legal and regulatory requirements, and maintaining product quality standards. The role involves team supervision, customer complaint handling, and liaison with government authorities. Key Responsibilities: Perform and supervise QC testing of raw materials, in-process and finished goods. Ensure compliance with GMP, cGLP, and internal quality standards. Liaison with regulatory bodies (FDA, BIS, Pollution Board, etc.) and handle inspections/audits. Address and investigate customer complaints; implement corrective actions. Train and guide QC staff and ensure adherence to SOPs and safety practices. Maintain documentation and ensure timely submission of regulatory reports. Qualifications & Experience: B.Sc./M.Sc. in Chemistry or related field. 510 years of QC experience in soap, fatty acid, or cosmetics industry. Knowledge of regulatory compliance and experience dealing with government authorities. Knowledge of Legal requirement able to liaison with govt authorities in his area of work,, Quality Control Activity for Soap & Fatty Acid Plant and other cosmetic products, To train and guide people working under him, GMP & cGLP, Handling of Customer Complaint.

Regulatory Affairs associate with knowledge in Indian Market. Customer & Regulatory communication and responses, Vendor qualification, Tracking of changes, Preparation of DMF's, Regulatory Affairs with knowledge in Indian Market. Required Candidate profile Candidates from Pharma background only with experience in Regulatory Affairs on Indian Market.

The Compliance Engineer will play a crucial role in ensuring product material regulations compliance. Collaborating with cross-functional teams and regulatory authorities, you will drive compliance initiatives to mitigate risks related to product material compliance against various regulations. You will deliver product information to iPoint Systems, submit detailed Product Bill of Materials (BOMs) along with part and supplier data, and perform high/low-risk parts analysis based on Material Data File (MDF) category risk assessments. Collaborating with Engineering and Portfolio/Product Management teams, you will ensure BOM data quality and accuracy. Additionally, you will work with Supply Chain Management (SCM) and Common Shared Services (CSS) teams to define regulation-specific data sets for supplier engagement. Analyzing material compliance information from suppliers, you will create product material compliance dashboards for effective monitoring and reporting. You will develop and maintain material compliance reports, including certifications and declarations for products, and report product material compliance to relevant authorities and customers. Identifying potential risks, you will closely work with product development teams to ensure compliance in design and manufacturing stages. Furthermore, you will provide technical support and guidance on material compliance-related queries, stay updated on regulatory legislation changes, and communicate these updates to stakeholders. The ideal candidate will have a Bachelor's degree in chemical engineering, Material Engineering, Mechanical engineering/Electrical engineering or related field with 3-6 years of experience. Proven expertise in material compliance, regulatory affairs, or related roles in R&D, Technology, Engineering, SCM, and manufacturing is required. Strong knowledge of product material regulations, industry standards, environmental regulations, and industry best practices is essential. Excellent analytical, problem-solving, and communication skills are crucial for effective cross-team collaboration. Attention to detail, accuracy, ability to work independently and in a team environment, and proficiency in spoken and written English are also necessary. Individuals with disabilities requiring accessibility assistance during the job application process can request reasonable accommodations by completing a general inquiry form on the Hitachi Energy website. Specific details about the required accommodation should be included to support the applicant during the application process. Requests for other purposes may not receive a response.,

You will be responsible for preparing, reviewing, and implementing Standard Operating Procedures of Quality Assurance, ensuring that day-to-day QA Controls are in place, and empowering QA for the entire plant. Your role will involve establishing, implementing, and maintaining the necessary processes for the Quality management system. You will adopt a document control procedure to approve, review, and update all changes to documents within the scope of the Quality Management System. Issuance of Quality Management System related formats and maintaining the log accordingly will be under your purview. You will be required to follow up on deviations, change controls, incidents, material and product destructions, Internal Audits, re-packing activities, and corrective & preventive actions with the respective departments. As part of your responsibilities, you will prepare risk assessment documents and ensure that the performance of the Quality Management System is reviewed at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. It will be your duty to maintain documents as per current Good Manufacturing Practices and to intervene and call meetings to resolve QMS and GMP related queries. You will provide documents for regulatory affairs and handle regulatory queries. Co-ordination with internal department personnel as well as external parties will be essential. Additionally, you will be responsible for audit preparation, execution, and compliance, as well as handling notifications to management regarding documents. Investigating and reviewing non-conforming events, including customer complaints and internal non-conforming events, and deciding on Corrective and Preventive Actions (CAPA) will be part of your role. You will prepare, review, and implement the Master list of Standard Operating Procedures and review qualification and validation documents. Reviewing and implementing the Annual Training Plan of GMP/Technical/SOP training, coordinating with the concerned departments for execution, and maintaining training records will be crucial. You will also be responsible for verifying and implementing the Batch Numbering system and allocating Equipment identification numbers, as well as reviewing and following up on the updating of equipment/instrument lists. Managing the update/review of the approved vendor list, vendor qualification planning, and documents will also fall within your responsibilities.,

We are looking for an experienced Regulatory Affairs professional with in-depth knowledge of injectable dossiers and a strong understanding of US FDA regulatory pathways. As the ideal candidate, you will have a crucial role in ensuring the successful submission and management of injectable products for regulated markets, with a focus on the United States. Your responsibilities will include compiling Abbreviated New Drug Applications (ANDAs) and Sterility Assurance Packages for ANDA filings. You will be expected to provide timely responses to ANDA deficiencies such as IRs, CRLs, and DRLs. Managing labeling compilation, including SPL files and annotated comparisons vs. RLD labels will also be a part of your role. You will be responsible for preparing Controlled Correspondence with regulatory bodies on various aspects such as Bioequivalence recommendations, Inactive ingredient levels, and Q1/Q2 sameness evaluation during early development. Additionally, you will need to file supplements for post-approval changes like PAS, CBE-30, and CBE-0. Your role will involve overseeing product lifecycle management by ensuring change control approvals and continuity through effective supplement filings. You will also be tasked with compiling Marketing Authorization Applications (MAAs) for the EU via DCP, MRP, and Centralized Procedure (Modules 15). Managing pre-ANDA meeting submissions for complex products with the USFDA will be one of your key responsibilities. You will also be expected to review Drug Master Files (DMFs), especially for complex peptides. If you feel that you are the right fit for this position, or if you know someone who might be suitable, please share your profile or connect with us at pratik.joshi@acmegenerics.in.,

As a Business Development Manager, your primary responsibility will be to identify new business opportunities in clinical research, regulatory affairs, medical writing, and biostatistics. You will be tasked with developing and executing strategic sales plans to achieve revenue targets. Your role will involve managing the end-to-end sales cycle, from lead generation to contract closure. Building and maintaining strong relationships with clients will be crucial to your success in this position. You will lead client presentations, proposal development, and contract negotiations, acting as a single point of contact for key clients to ensure satisfaction and repeat business. Conducting market research to identify industry trends, competitor activities, and client needs will also be a key aspect of your role. Providing insights into pricing strategies, service differentiation, and new market opportunities will help drive business growth. As a Business Development Manager, you will represent the company at industry conferences, networking events, and exhibitions. Collaboration with cross-functional teams will be essential to achieving sales targets and business objectives. You will oversee the development of RFPs (Request for Proposals), RFIs (Request for Information), and client proposals while negotiating contracts to ensure profitability and compliance with company policies. Tracking and analyzing sales performance, revenue growth, and business forecasts will be part of your regular responsibilities. Maintaining an updated CRM (Customer Relationship Management) database with client interactions will also be a critical aspect of your role. This is a full-time, permanent position with health insurance benefits. The work schedule is Monday to Friday, and the work location is in person.,

Roles & Responsibilities: Preparation and timely update of Technical Files Regular updating of the Quality Manual Review and update of all relevant Standard Operating Procedures (SOPs) Review and revision of Work Instructions as per process requirements Preparation of Marketing Support Documents from QA perspective Review and update of internal Formats and Templates Periodic review and update of Site Master Files Must have working knowledge of various audits related to the medical device industry , including ISO 13485 , MDSAP, and CDSCO inspections

A. About the Role: Candidate should be able to assist in execution of assignments in Regulatory, Policy, Tariff, or Commercial related matters pertaining to Power Distribution Utilities. The person will be responsible for the preparation of Tariff Petitions along with Financial Models including power purchase portfolio FSA petitions and other commercial related petitions. Advising on the Amendments in the different Regulations, Acts, Policies, and Plan etc. and periodic review of regulatory developments in SERC / CEA/ MOP. Candidate will be responsible for providing comprehensive support to Power Distribution Utility in all day-to-day and routine regulatory matters pertaining to State Regulatory Commission. The key responsibilities of this role will include the following: B. Job Responsibilities: Petition filing and Compliance: Prepare and file ARR, Tariff Petition, True-up Petition, and Annual Performance Review Petition for all DISCOMs within the contract period. Ensure compliance with outstanding directives issued by SERC and prepare compliance reports. File the MYT Petition for the next control period during the engagement and submit FSA petitions quarterly to the Hon'ble Commission. Prepare petitions in accordance with SERC regulations, covering performance trajectory, sales and demand forecast, and investment and financing plans. Studies and Reports: Conduct various studies recommended by the commission (SERC), including cost-of-service studies for different categories or voltage levels. Assist in preparing a report on compliance with directives issued by SERC in previous orders. Public Hearing Representations: Attend public hearings on Tariff Proposals of Power Distribution Utility as directed by SERC. Provide detailed written replies to objectors' suggestions and queries from SERC during the Public Hearing. Support Power Utility in oral responses to queries during public hearings. Analysis of Orders: Analyze MYT/Tariff Orders issued by SERC and assess the approval of costs versus claims, presenting rationales for disallowance and financial/operational impact assessments. Assist in filing review petitions before SERC, if required. Handle filing and responses to petitions before SERC during public hearings. Analyze SERC orders pertaining to Power Distribution Utility, assess the impact, and recommend further action, including filing review petitions, if necessary. Business Plan Preparation: Prepare the Business Plan for Power Distribution Utility as required by SERC or regulatory mandates. Provide supporting data and information for justifying business plans and MYT petitions. Analyze draft and final regulations, orders, rules, codes, and notifications issued by SERC. Assess the impact on finances and operations and recommend necessary actions. Provide inputs on draft regulations, orders, rules, codes, and notifications when required. Data Collection and Analysis: Develop data collection formats and gather necessary data from each utility. Perform data analysis and validate data for accuracy. C. Required skill set Proven experience in handling regulatory matters within the electricity distribution sector. Familiarity with distribution schemes in the energy industry. Strong analytical and problem-solving skills. Excellent communication and collaboration abilities. Ability to develop and implement effective strategies. Capacity to work independently and as part of a team. Flexibility to adapt to dynamic and evolving requirements. Strong interpersonal and Communication skills. Proficiency in MS Office (Word, Excel and Power point) D. Education and Experience BE/B. Tech (preferably in Electrical) plus MBA (preferably in Power or Finance), or CA Atleast 5 years of relevant experience

Filtrex Technologies Pvt. Ltd. As a part of the global industrial organization Marmon Holdings which is backed by Berkshire Hathaway you ll be doing things that matter, leading at every level, and winning a better way. We re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone s empowered to be their best. We are seeking a detail-oriented and proactive Regulatory Certification Engineer to maintain product certifications for the KX Technologies and Filtrex portfolios. This role ensures timely submission of certification applications, supports internal teams with regulatory guidance, and contributes to strategic certification initiatives. The ideal candidate will stay current with global standards and provide exceptional service to both internal and external stakeholders. This position will be based out of Bangalore, India. Job Requirements Manage end-to-end certification processes for new and existing products. Ensure compliance with relevant industry standards and regulatory requirements. Prepare and submit applications for product certifications and registrations. Act as a liaison between internal teams, customers, and certification bodies. Support customer-owned product certifications and related documentation. Maintain accurate records of certification activities and financial transactions. Monitor regulatory changes and ensure ongoing compliance. Identify and implement process improvements in certification workflows. Participate in relevant industry committees and certification-related projects. Professional and Technical Skill Requirements Bachelor s degree required, technical field preferred (e.g., Chemistry, Engineering, Biology) Minimum 3 years of experience with regulatory affairs, drinking water preferred Strong knowledge of NSF/ANSI DWTU and DWA standards and certification required Familiarity with ACS, Halal, KC, KTW, WRAS, JIS certification preferred Knowledge of BIS, AS/NZS, ABNT, EU DWD standards is a plus Excellent written and verbal communication skills Understanding of change management and document control processes Strong organizational skills and project management abilities Proficiency in Access Database or Epicor is an advantage Why Join Us? Work with a global leader in water filtration technologies. Be part of a collaborative and innovative team. Contribute to products that impact health and sustainability worldwide. Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law .

Responsibilities: * Prepare CDSCO dossiers & manage vendors * Conduct clinical research, formfilling expertise required * Ensure compliance with regulatory standards * Manage SUGAM portal submissions have experience in indian regulatory

KPMG India is looking for Executive - Adobe QA 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.

We are Reckitt Home to the worlds best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege. Research & Development In Research and Development, were full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance. We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality. The size of our organisation means youll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation. About the role This pivotal Regulatory Manager role offers you the opportunity to champion collaboration across teams, enhancing your leadership abilities. As the bridge between Reckitt and regulatory agencies, your expertise will be key in guiding our innovative products through complex regulatory landscapes to reach consumers safely and efficiently. This role also offers great promotion opportunities, with a Senior Manager position being the next step for strong performance. Your responsibilities - A minimum of 6 years in regulatory affairs, crafting strategies and guiding teams through submission processes. - Aptitude for strategic thinking and making informed business decisions under pressure. - Keen business accumen with a clear understanding of product lifecycle management and consumer insights. - Proven capacity to foster business partnerships and manage relationships, with a collaborative approach. - Flexibility to adapt to technological advancements and the courage to suggest and implement improvements. - An innovative mindset ready to engage in digital transformations within R & D, Quality, and Manufacturing sectors. The experience were looking for - A minimum of 6 years in regulatory affairs, crafting strategies and guiding teams through submission processes. - Aptitude for strategic thinking and making informed business decisions under pressure. - Keen business accumen with a clear understanding of product lifecycle management and consumer insights. - Proven capacity to foster business partnerships and manage relationships, with a collaborative approach. - Flexibility to adapt to technological advancements and the courage to suggest and implement improvements. - An innovative mindset ready to engage in digital transformations within R & D, Quality, and Manufacturing sectors. The skills for success Business Strategy, Task Execution Under Pressure, Makes strategic Business Decisions, Business accumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, Creative Direction, R&D, Change Leadership, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Relationship Management, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes, Digital transformation for R&D, Quality and Manufacturing. What we offer With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitts potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitts pay for performance philosophy. We recognise that in real life, great people dont always tick all the boxes. Thats why we hire for potential as well as experience. Even if you dont meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.

We are Reckitt Home to the worlds best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege. Research & Development In Research and Development, were full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance. We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality. The size of our organisation means youll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation. About the role As a Regulatory Associate, you re at the forefront of shaping the synergy between our innovative products and the regulatory framework that guides them. Seeking a meticulous and proactive individual, this role offers you the chance to be the regulatory lead on pivotal projects, honing your communication skills, and nurturing robust partnerships all while delivering critical tasks that influence our global presence. Your contributions will be impactful and meaningful, as you begin to navigate and influence the regulatory scenery that defines our industry. Your responsibilities - Collaborate with the team while taking on independent responsibility for regulatory innovation and compliance activities. - Interpret and implement regulations and guidelines as needed to foster industry compliance. - Engage with trade associations, contributing to and utilising our resources to influence favourable legislation. - Understand the regulatory necessities of diverse projects, actively participate in them, and remain alert to project advancements and their benefits. - Manage updates and actions in your area, ensuring tasks are completed effectively and efficiently. The experience were looking for - Proven track record with at least 3 years in regulatory affairs, showcasing full proficiency in this roles requirements. - Proficient in multitasking, executing tasks under pressure, and making objective decisions when faced with complex issues. - Acute business acumen accompanied by commercial awareness. - Demonstrated ability to cultivate insights from consumer interactions and translate them into strategic actions. - Skilled in collaborating with teams across various functions, fostering an environment of partnership building. - Agility to adapt to the ever-evolving technological landscape, complemented by a mindset that seeks to improve and advance current processes. - Experience with product lifecycle management, intellectual property, and innovative workflows. The skills for success Task Execution Under Pressure, Business Acumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, R&D, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes. What we offer With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitts potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitts pay for performance philosophy. We recognise that in real life, great people dont always tick all the boxes. Thats why we hire for potential as well as experience. Even if you dont meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.

Job Overview Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff; Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate; Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; Prepares and/or reviews regulatory documentation in area of expertise, as appropriate; Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters; Understands the Scope of Work, deliverables for any given project; May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person; May prepare and deliver trainings, as appropriate; Performs other tasks or assignments, as delegated by Regulatory management; Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex; Qualifications Bachelors Degree Degree in Lifescience or related discipline Req Or Masters Degree Degree in Lifescience or related discipline Req At least 2 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Good, solid interpersonal communication (oral and written) and organisation skills; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable; Demonstrates self-motivation and enthusiasm; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff; Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate; Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; Prepares and/or reviews regulatory documentation in area of expertise, as appropriate; Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters; Understands the Scope of Work, deliverables for any given project; May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person; May prepare and deliver trainings, as appropriate; Performs other tasks or assignments, as delegated by Regulatory management; Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex; Qualifications Bachelors Degree Degree in Lifescience or related discipline Req Or Masters Degree Degree in Lifescience or related discipline Req At least 2 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Good, solid interpersonal communication (oral and written) and organisation skills; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable; Demonstrates self-motivation and enthusiasm; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com

Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Navi Mumbai, India, 400706 Who we are The opportunity The Director, Regulatory Affairs Post-Approval (US Generics) is a senior regulatory leader responsible for independently setting the strategic direction and ensuring the successful execution of all post-approval regulatory activities for U. S. FDA-regulated generic drug products. This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes. The Director leads a team of regulatory professionals and serves as a key liaison with the FDA, internal stakeholders, and external partners. How you ll spend your day Define and lead the global regulatory strategy for post-approval lifecycle management of U. S. FDA-approved ANDAs/NDAs, ensuring alignment with business goals and regulatory expectations. Oversee the preparation, review, and submission of all CMC post-approval regulatory filings, including CMC Supplements (CBE-0, CBE-30, and PAS), Annual Reports (both active and inactive), REMS updates, general correspondences and controlled correspondences Serve as the primary regulatory authority on post-approval matters, providing expert guidance to executive leadership and cross-functional teams. Lead regulatory assessments and decision-making for complex changes, including site transfers, formulation changes, alternate APIs, etc. Establish and maintain strong relationships with FDA project managers. Monitor and interpret evolving FDA regulations, guidances, and enforcement trends; proactively adapt strategies and internal processes. Develop and implement regulatory policies, SOPs, and training programs to ensure consistent and compliant practices across the organization. Lead, mentor, and develop a high-performing regulatory team, fostering a culture of accountability, innovation, and continuous learning. Represent Regulatory Affairs in global governance forums, strategic planning sessions, divestment assistance and support of internal initiatives. Initiate/manage notices of commercial launch and product obsoletion, as well as updates to the Orange Book. Your experience and qualifications Pharm D or M. Pharma in a scientific discipline. Minimum 15+ years of pharmaceutical industry experience, with at least 10+ years in U. S. Regulatory Affairs focused on managing the lifecycle of generic drug products. Proven leadership (8+ years in a supervisory role) in independently managing a large regulatory team, as well as a large and diverse post-approval portfolio consisting of various, globally manufactured dosage forms and complex supply chains. Deep expertise and applied knowledge of FDA regulations (21 CFR 314. 70), ICH guidelines, and eCTD submission standards. Experience with regulatory systems (e. g. , Veeva, TrackWise) and electronic document management systems (e. g. Wisdom, Glorya, Livelink, Knowledgetree). Demonstrated success in leading regulatory strategy, agency interactions, and lifecycle management for ANDAs/NDAs. Strong business acumen and ability to align regulatory strategies with commercial and operational objectives, while maintaining regulatory compliance. Demonstrates a basic understanding of pharmaceutical drug development. Demonstrated/proven track record of FDA interactions, as well as negotiation and influencing skills. Demonstrates excellent verbal and written communication skills. Experience working in a matrixed, multinational environment, as well as with third parties. Experience with regulatory intelligence, policy shaping, and industry advocacy is a plus. Lean Six Sigma certification, or other accreditation related to improving business processes is a plus. The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

The candidate must possess in-depth functional knowledge of the process area and apply it to operational scenarios to provide effective solutions. The candidate must be able to identify discrepancies and propose optimal solutions by using a logical, systematic, and sequential methodology. It is vital to be open-minded towards inputs and views from team members and to effectively lead, control, and motivate groups towards company objects. Additionally, the candidate must be self-directed, proactive, and seize every opportunity to meet internal and external customer needs and achieve customer satisfaction by effectively auditing processes, implementing best practices and process improvements, and utilizing the frameworks and tools available. Goals and thoughts must be clearly and concisely articulated and conveyed, verbally and in writing, to clients, colleagues, subordinates, and supervisors. Associate Process Manager Role and responsibilities: Process and monitor incoming payments and outgoing invoices. Reconcile accounts payable and receivable balances on a regular basis. Manage and maintain accurate records of all financial transactions. Resolve any billing discrepancies and respond to vendor inquiries. Prepare and process electronic transfers and payments. Assist with monthly, quarterly, and annual financial reporting and audits. Maintain vendor files and ensure all documentation is up to date. Coordinate with internal departments to ensure efficient invoicing and payment processes. Qualifications Bachelors degree in Finance, Accounting, or related field. 4+ years of experience in accounts payable and/or receivable. Strong knowledge of basic accounting principles and financial regulations.

We are looking for a young and talented individual to market our specialized products within the travel agents network in Maharashtra & Gujarat People with prior experience within the travel industry , specifically looking into channel sales will be preferred The job will require traveling within Mumbai & the states of Maharashtra & Gujarat Our Major Products will include Ladakh tours for the Summer along with Europe & Sri Lanka tour products

Incoda Media is looking for Assistance Manager / Manager - Media 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 company€™s 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