225 Regulatory Operations Jobs - Page 7

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: BCom/B.B.M Years of Experience: 0 to 1 years 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, medical and health services, budgeting and ratin...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs 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 aligne...

Key skills required by this role includes: Understand Regulatory operations Gather, review and analyse data regarding the business and its operations; prepare models and process maps for improvements; and communicate findings and suggestions to key stakeholders Understanding software requirements, ability to translate business need into functional and technical requirements Skilled in documentation and timely response and sharing of information Ability to perform discussion with customer Ability to effectively report on status of work Break down requirements in user stories Ability to verify the functionality in the solution. Ability to write test cases/scripts and execute them.

As a Regulatory Affairs Associate II, Labeling at Teva Pharmaceuticals, you will play a crucial role in preparing and revising high-quality US Gx labeling documents for submission under an ANDA and/or 505(b)(2). Your responsibilities will include ensuring compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. You will be expected to work with minimal supervision and demonstrate a thorough understanding of US FDA labeling regulations and guidance documents. Your tasks will involve creating compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information, and adhering to compliance r...

As a Labeling Specialist in the Pharmaceutical Industry, you will be responsible for developing US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s. Your role will involve ensuring that labeling meets all legal and regulatory requirements through QC, proofing, editing, and formatting of documents. You will coordinate the review and approval of final submission documents with all relevant departments. Your expertise will be crucial in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities. Serving as a Subject Matter Expert (SME) in SPL/drug listing, you will provide gu...

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...

About The Role Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Customer Service Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years 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, medical and health services, budgeting and ...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years 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, medical and health services, budgeting and r...

Candidate shall be responsible for assuming the role for the assigned specialty programs (NCE/BLA) and be accountable for regulatory operations activities. This includes, but is not limited to, CTA applications in EU, LATAM, USA, Canada, ROW, CTIS management, submission management, eCTD publishing of all modules, document management, etc. It is essential to have a comprehensive understanding and stay updated with current Global Regulatory filing requirements and eCTD/CTIS structure. You will collaborate with Strategists (Leads) and coordinators for submission strategy and timelines. Moreover, you will be required to prepare Regulatory Management Plan and Submission content plan for CT. The r...

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation 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 Scienc...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare operati...

The Manager of Regulatory Affairs, Labeling at Teva Pharmaceuticals is responsible for supervising, critically reviewing, and approving established US Gx labeling documents filed under an ANDA/505(b)(2) by team members in the US and Mumbai/Bangalore locations. The Manager must ensure compliance with federal regulations, internal processes, and company goals while meeting established timelines. Additionally, they will oversee team databases and trackers, updating them as needed. The ideal candidate should have a strong understanding of FDA US labeling regulations and guidances for products filed under an ANDA/505(b)(2) and be a Subject Matter Expert in US labeling, including SPL, PADERs, and ...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years 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, medical and health services, budgeting and rating, research...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate 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...

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, our most valuable asset is our people. Here youll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning; bold ideas; courage and passion to drive life-changing imp...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare operati...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Embedding digital transformation in healthcare operati...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Master of Pharmacy Years of Experience: 1 to 3 years 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...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years 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 c...

As a Regulatory Operations Associate at ICON plc, a world-leading healthcare intelligence and clinical research organization, you will be an integral part of our mission to shape the future of clinical development. Our inclusive environment fosters innovation and excellence, and we invite you to join us in making a difference in patients" lives. At ICON, our people are at the heart of everything we do. Our diverse teams enable us to better partner with our customers and work towards advancing and improving patient outcomes. Our culture is defined by four key values: Accountability & Delivery, Collaboration, Partnership, and Integrity. We strive to be the preferred Clinical Research Organisat...

Looking for a fresher in Regulatory Affairs to assist in document preparation, product registration, and compliance with national and international regulations. Strong communication skills, attention to detail, and a science background are preferred.

At Rockstar Games, you will be part of a team that creates world-class entertainment experiences. You will have the opportunity to work on rewarding and large-scale creative projects within an inclusive and highly-motivated environment. Collaborate with talented individuals in the industry and contribute to the ongoing growth of the Rockstar Games Creator Platforms, including the FiveM and RedM modification platforms for Grand Theft Auto 5 and Red Dead Redemption 2. As an Associate Compliance Manager at Rockstar India, you will support the day-to-day operations of the Creator Platform Compliance team. Your role involves ensuring a safe and enjoyable environment for all users by ensuring comp...

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation 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 Scienc...

The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Pr...

Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical ...