2122 Regulatory Affairs Jobs - Page 18

The successful candidate will be responsible for developing and implementing regulatory strategies for new products, managing the life cycle of existing products, conducting SEC meetings, and drafting critical responses to new product queries and legal matters. Key Responsibilities: - Develop and implement overall regulatory strategy for new products. - Manage the life cycle of existing products, ensuring compliance with regulatory requirements. - Conduct SEC meetings and ensure all regulatory submissions are accurate and timely. - Draft critical responses to new product queries and legal matters. - Collaborate with cross-functional teams to ensure regulatory compliance and support product d...

As a Drug Regulatory Affairs Specialist at MEDYUR PHARMACEUTICALS LIMITED, you will be responsible for ensuring compliance with regulatory requirements for our products. Your role will involve collaborating with cross-functional teams to drive successful product launches and maintain regulatory compliance. Your responsibilities will include preparing and submitting regulatory documentation, staying updated on global regulatory requirements, developing relationships with regulatory bodies, reviewing changes in regulatory policies, conducting regulatory impact assessments, maintaining regulatory files, and supporting regulatory inspections and audits. You will also collaborate with internal te...

As a Site Activation Specialist I at Syneos Health in Beijing/Shanghai, you will be responsible for ensuring the quality of deliverables at the country level, adhering to project requirements and applicable country rules under the oversight of the SSU Country Manager. Your role will involve working within forecasted submission/approval timelines, tracking milestone progress in real-time, and providing clear rationale for any delays while assisting in developing contingency plans to mitigate impacts. You will also monitor basic financial aspects of the project, escalate discrepancies promptly, and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) while keeping train...

At Capgemini Invent, we believe that difference drives change. As inventive transformation consultants, we blend our strategic, creative, and scientific capabilities, collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow. Informed and validated by science and data, superpowered by creativity and design, all underpinned by technology created with purpose. The GxP CSV Validation Engineer plays a crucial role in ensuring that digital systems used in clinical development comply with regulatory standards such as GxP, 21 CFR Part 11, and EMA Annex 11. Responsibilities include developing and ex...

Fishfa Biogenics is offering opportunities for professionals in various functions such as Operations, Quality, Sales & Marketing, Human Resources, Finance, Business Development, Logistics, EHS, and Regulatory Affairs. We are currently looking for individuals to join our team in the API Bio-processes department for Column purification / Solvent extraction and Downstream Production. Position: Operator Experience: 2-5 Years Qualification: ITI or equivalent Vacancy: 2 positions At Fishfa Biogenics, we believe in fostering a work environment that encourages new ideas and provides individuals with the freedom to explore. We value and reward employees who contribute towards achieving our company's ...

Fishfa Biogenics is offering opportunities for professionals in various functions such as Operations, Quality, Sales & Marketing, Human Resources, Finance, Business Development, Logistics, EHS, and Regulatory Affairs. We are looking for talented individuals to join our team. If you have 2-5 years of experience and hold an ITI or equivalent qualification, we have a position available for you in the API Bio-processes (Fermentation) Upstream Production department as an Operator. At Fishfa Biogenics, we value a work environment that fosters new ideas and provides the freedom to explore. We believe in rewarding employees who contribute towards achieving our company's vision and growth for a bette...

At Capgemini Invent, we believe in the power of diversity to drive change. As inventive transformation consultants, we leverage our strategic, creative, and scientific capabilities to collaborate closely with clients and deliver cutting-edge solutions. Join our team to lead transformation tailored to address our clients" challenges of today and tomorrow. Our approach is informed and validated by science and data, superpowered by creativity and design, all underpinned by technology created with purpose. Product Owners at Capgemini play a crucial role in balancing business strategy, user needs, and development efforts. They often act as proxies for our clients, communicating a compelling produ...

The Quality & Compliance Subject Matter Expert for Hard Goods position in Bangalore within the Quality & Compliance department is seeking experienced professionals to ensure that hard goods such as furniture, home appliances, tools, and other durable goods meet regulatory, safety, and quality standards. As a Quality & Compliance SME, you will collaborate with cross-functional teams, including product development, supply chain, and regulatory bodies, to maintain compliance with global and regional standards. Your key responsibilities will include ensuring regulatory compliance for hard goods in alignment with safety, quality, and environmental regulations. You will be responsible for developi...

As the Head Risk and Regulatory Officer for our leading International Exchange located in Ahmedabad / Gandhinagar, you will be responsible for leading the Risk and Regulatory Team. Your key duties will include providing guidance, coaching, and assistance to the team members. You will collaborate with other Key Management Personnel to integrate Regulatory Compliance into business plans and operations. In this role, you will oversee the protection of the risk department's information technology and risk monitoring operations. You will also be in charge of presenting risk policies and regulatory initiatives to the board, regulators, and other stakeholders. Additionally, you will manage the risk...

Enterprise Information Security (EIS) is committed to appropriately protecting all information relating to its caregivers and affiliates, as well as protecting its confidential business information (including information relating to its caregivers, affiliates, and patients), What will you be responsible for Develop, maintain, monitor and enforce IT policies and procedures Development, implementation and compliance of information risk management across the enterprise Support establishing information security governance framework Manage risks related to the use of information technology, information security, privacy, regulatory compliance and governance, Drive risk management and governance s...

Your Role and Impact **Job Title: AI-ML Automation Expert ** **Company: R Systems** **Location: Pune, Maharashtra, India** **Experience: 7 9 years** About Us R Systems is a global technology and consulting services company committed to delivering innovative solutions that empower businesses to achieve their objectives We leverage cutting-edge technology to drive efficiency and elevate the customer experience Join our dynamic team to make a meaningful impact in the field of automation and artificial intelligence, Job Description We are seeking a skilled AI-ML Automation Expert (Billing) with a strong background in AI agent development and integration The ideal candidate will have between 7 to...

Who We Are Together, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives Its a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds Working here means working with the worlds leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organizations Essential Medicines List Today, at least 200 million people around the world take one of our medicines every single day An amazing number, but were always looking for new ways to continue making a difference, and new people to make a difference with, The opportu...

Who We Are Together, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives Its a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds Working here means working with the worlds leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organizations Essential Medicines List Today, at least 200 million people around the world take one of our medicines every single day An amazing number, but were always looking for new ways to continue making a difference, and new people to make a difference with, How Youll S...

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

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

About The Role Project Role : Application Tech Support Practitioner Project Role Description : Act as the ongoing interface between the client and the system or application. Dedicated to quality, using exceptional communication skills to keep our world class systems running. Can accurately define a client issue and can interpret and design a resolution based on deep product knowledge. Must have skills : Application Packaging Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Tech Support Practitioner, you will serve as a vital link between clients and the systems or applications they utilize....

About The Role Project Role : Application Support Engineer Project Role Description : Act as software detectives, provide a dynamic service identifying and solving issues within multiple components of critical business systems. Must have skills : Asset Management Good to have skills : Asset Life Cycle ManagementMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Support Engineer, you will act as software detectives, providing a dynamic service identifying and solving issues within multiple components of critical business systems. Your day will involve troubleshooting, analyzing, and resolving software-related issues ...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations Associate Qualifications: BCom Years of Experience: 1 to 3 years Language - Ability: English(Domestic) - Intermediate What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medic...

Position Title: Regulatory Affairs & QA Manager Department: Quality & Regulatory Affairs Location: Bangalore Role Overview The Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485, MDR, US FDA, and other relevant standards. This role is critical in bridging product development, regulatory submissions, audits, and market access, ensuring patient safety and product quality at all times. Key Responsibilities Regulatory Affairs: Develop and implement regulatory strategies for product registration, approvals, and cert...

Role & responsibilities Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative...

Ruby Chemicals is looking for Specifications Manager to join our dynamic team and embark on a rewarding career journey. Delegating responsibilities and supervising business operations Hiring, training, motivating and coaching employees as they provide attentive, efficient service to customers, assessing employee performance and providing helpful feedback and training opportunities. Resolving conflicts or complaints from customers and employees. Monitoring store activity and ensuring it is properly provisioned and staffed. Analyzing information and processes and developing more effective or efficient processes and strategies. Establishing and achieving business and profit objectives. Maintain...

Job Summary We are seeking a dynamic Formulation Scientist in BRaIN for designing and development of formulation, process, and ensure seamless end to end product development. Roles & Responsibilities You will be responsible for the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible to co-ordinate closely with analytical team to devise effectiveProof of Concept (POC). You will be responsible to support in scale-up to pilot/plant scales for OSD Products. You will be responsible for performing pre-formulation studies for material char...

We are looking for Right of Way (ROW) and Lead land acquisition processes for high voltage transmission projects. Handle negotiations, legal documentation, govt. clearances, and stakeholder management to ensure smooth and timely project execution.

The job can be done at remote and candidate has to work/meeting at least from 20.00 hrs to 24 hrs at US time. Based on time sheet, the candidate the client will compensate remuneration.

Job description Experience & Skills required: Experience in new development / product life cycle management associated with regulatory function. Well versed with product development / Manufacturing and sterility assurance, deficiency management. Well versed with labelling requirements. Well versed with eCTD operations. Experience in handling drug device combination products. Good written and verbal communication. Markets: US / EU - Majorly. Experience required: 5-9 yrs in sterile formulations - US market. Qualification: M.Pharmacy