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3.0 - 5.0 years

4 - 8 Lacs

bengaluru

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About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shared Serv...

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5.0 - 8.0 years

5 - 9 Lacs

bengaluru

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About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shar...

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3.0 - 5.0 years

4 - 8 Lacs

bengaluru

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About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shared Serv...

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3.0 - 5.0 years

4 - 8 Lacs

bengaluru

Work from Office

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shared Serv...

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5.0 - 8.0 years

5 - 9 Lacs

bengaluru

Work from Office

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shar...

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5.0 - 8.0 years

5 - 9 Lacs

bengaluru

Work from Office

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shar...

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3.0 - 5.0 years

4 - 8 Lacs

bengaluru

Work from Office

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shared Serv...

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3.0 - 5.0 years

4 - 8 Lacs

gurugram

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About The Role Candidates key responsibilities would include supporting the London Tax team in the following areas quarterly tax provisions and forecasting process for EMEA House entities including the reporting of cash tax payments and the preparation of uncertain tax positions (FIN 48) calculations. annual corporate tax compliance for EMEA House entities, including performing a first level review of the local tax advisors work papers and draft tax returns and partnering with them to ensure the timely submission of all tax filings and settlement of local tax liabilities. preparation and collation of tax data for EMEA House entities in respect of the annual tax reporting requirements for the...

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10.0 - 15.0 years

7 - 10 Lacs

noida

Work from Office

Summary: Are you passionate about optimizing technology landscapes to enhance operational efficiency and drive cost savings? As an Application Rationalization Consultant, you will play a critical role in streamlining our application portfolio, ensuring that each application aligns with business objectives and delivers maximum value. You will collaborate with IT, business stakeholders, and vendors to assess, prioritize, and consolidate applications, driving innovation and efficiency. Join a dynamic environment where your expertise will help shape the future of our technology ecosystem. Detailed Responsibilities: Conduct comprehensive assessments of the current application portfolio to identif...

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10.0 - 15.0 years

12 - 16 Lacs

amritsar

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The ideal candidate brings 10- 15 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Lead microbiology practices including EM, MLT, sterility ...

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2.0 - 5.0 years

2 - 5 Lacs

navi mumbai, india

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Job Description Position Summary We are seeking a Senior Officer- Regulatory affairs (US Markets ) to join our team, he will be reporting to Deputy General Manager in this role, you will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approval Key Responsibilities: Collate/prepare and file dossiers in a timely and accurate manner for formulations/ drug products to get licenses from targeted markets. Prepare the checklist for documentation for regulatory filings as per current regulatory requirements (country specific). Collate and conduct review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations, E...

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1.0 - 5.0 years

0 Lacs

navi mumbai, maharashtra

On-site

Role Overview: As a RA Associate I at the company, you will be responsible for preparing and revising high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2. You will ensure adherence to federal regulations and meet deadlines to align with company goals. Your role will involve developing compliant Structured Product Labeling (SPLs) files with complete drug listing information. Key Responsibilities: - Develop US labeling documents for assigned ANDAs and/or 505(b)(2)s, ensuring alignment with company goals and submission requirements while meeting all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents. - Establish SPL for assig...

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15.0 - 20.0 years

5 - 9 Lacs

coimbatore

Work from Office

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Appian Process Automation Good to have skills : NAMinimum 2 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications funct...

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4.0 - 6.0 years

3 - 7 Lacs

hyderabad

Work from Office

What you will do In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial Management, Monitoring, and Engagement...

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3.0 - 8.0 years

6 - 10 Lacs

hyderabad

Work from Office

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India . The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries. The team member will be responsible for maintaining U.S. state and federal com...

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4.0 - 9.0 years

3 - 6 Lacs

hyderabad

Work from Office

ABOUT THE ROLE The Regulatory Affairs Senior Associate role assists US Promotion Regulatory representatives and other cross-functional roles in the administration of regulatory strategies for department initiatives across all product brands. This role assists with preparing, tracking, reporting, and archiving US regulatory documentation, including preclearance and advisory comment promotional materials, and is responsible for all Ad/Promo regulated data management. This role performs the planning and tracking of all US promotional label changes and manages the system update of promotional labeling and Important Safety Information (ISI). This role is responsible for US digital labeling and tr...

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2.0 - 7.0 years

3 - 7 Lacs

hyderabad

Work from Office

The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable regulations. R egulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is...

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3.0 - 8.0 years

10 - 14 Lacs

hyderabad

Work from Office

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or ...

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3.0 - 8.0 years

11 - 15 Lacs

hyderabad

Work from Office

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and act...

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3.0 - 7.0 years

5 - 10 Lacs

pune, chennai

Work from Office

Before you apply to a job, select your language preference from the options available at the top right of this page. Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrowpeople with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level. About The Role : Job Summary This position provides input, support, and performs full systems life cycle management activities (e.g., an...

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2.0 - 7.0 years

3 - 6 Lacs

hyderabad

Work from Office

Role Description: The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: With support, advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Lia...

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2.0 - 5.0 years

10 - 14 Lacs

hyderabad

Work from Office

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities

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8.0 - 13.0 years

7 - 10 Lacs

hyderabad

Work from Office

What you will do Lets do this. Lets change the world. Roles & Responsibilities: Act as the Regional Service Delivery Lead for Deskside Support Services, representing DSS across regional IS and business teams. Lead and manage the MSP to ensure effective delivery, performance, and continuous improvement of deskside services. Partner with global DSS service owners and regional IS leads to align regional service models with global strategy. Monitor and govern SLAs, KPIs, and operational metrics, ensuring service excellence and proactive remediation of issues. Supervise hardware asset management and device lifecycle processes, including procurement, deployment, and retirement. Leverage platforms ...

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5.0 - 8.0 years

7 - 10 Lacs

hyderabad

Work from Office

Role Name: Manager International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to -optimize product development and regulatory approvals in International countries -develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities -Advises Global teams on regulatory impl...

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3.0 - 8.0 years

7 - 10 Lacs

hyderabad

Work from Office

Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance. Join us in revolutionizing regulatory submissions through cutting-edge data automation! Key Responsibilities: Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows. Assist in developing standardized templates a...

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