Regulatory Data & Systems Manager Job at Amgen (Hyderabad)

Regulatory Data & Systems Manager

The Regulatory Data & Systems Manager will be responsible for facilitating syste...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors
5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies
Excellent oral and written communication skills
able to organize and present ideas in a convincing and compelling manner
Ability to operate effectively in a matrix environment
team player yet able to work independently with minimal direction
Familiarity with GxP requirements and systems validation
Life Sciences, Biotech or pharmaceutical industry experience preferred
Proven Veeva Vault knowledge
Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 8 years of directly related experience OR High school diploma / GED and 8 years of directly related experience

Job Responsibility

System Administration: Manage and maintain the organization's IT systems, ensuring they are secure, efficient, and compliant with regulatory requirements
Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices
Project Coordination: Assist in planning, tracking, and executing departmental projects and initiatives
Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates

Manager, Data Systems Development

Under the general supervision of the GSOC Director, Data Systems, this position ...

Location

United States , Tucker, Georgia

Salary:

139120.00 - 173900.00 USD / Year

Georgia System Operations

Expiration Date

Until further notice

Requirements

Bachelor's Degree, Information Technology or related Computer Science discipline
10+ years of professional software development experience, with a strong focus on C# and Microsoft technologies
Minimum of five years of direct experience with increasing responsibility in planning and leading multiple, concurrent, IT projects
In-depth knowledge of power systems, engineering principles, data modeling, data warehousing, system architecture, source control tools (e.g., GIT), and cloud computing technologies
Leadership: Demonstrated experience in progressive and operational leadership, with a proven ability to empower teams, drive collaboration, and implement innovative solutions to achieve organizational objectives and enhance overall performance
Microsoft Azure Experience: Proven experience with Microsoft Azure services, including architecture design, migration strategies, and deployment processes
Cloud-Native Application Design: Strong understanding of cloud-native application development, DevOps methodologies, and CI/CD pipeline implementation
Source Control Proficiency: Hands-on experience with source control tools, specifically GIT, to manage and track changes in codebases
Server Administration Skills: Familiarity with servers, IIS (Internet Information Services), and administration tools to support system operations and maintenance
Technical Knowledge: Working knowledge of JSON and PowerShell scripting for automation and system configuration

Job Responsibility

Operations Management (30%): Ensure daily operations are efficient and projects meet quality standards. Maintain knowledge of IT trends in the electric utility industry and develop infrastructure to support networking, application development, database administration, security, compliance, and automation. Hold teams accountable for performance, seek continuous improvement, and allocate resources effectively. Ensure systems are updated to meet regulatory and corporate needs while maintaining compliance. Develop and present materials to board committees and directors for GSOC, OPC, GTC, or Members
Strategic Management (30%): Understand customers' business and strategic initiatives, anticipate requirements, and develop departmental strategies to support corporate objectives. Manage teams to complete projects, including planning, estimating, scheduling, analysis, design, package selection, and implementation. Ensure methodologies are consistently applied and project deliverables align with business requirements and corporate technology strategies. Maintain project schedules and budgets, provide proactive support to the GSOC Director, and develop plans to improve team effectiveness. Ensure organizational readiness to manage change and comply with evolving industry and regulatory standards
Personnel Management (25%): Manage staff through hiring, training, coaching, and performance reviews. Resolve conflicts, monitor progress, and provide feedback to ensure deliverables meet expectations. Promote professional growth, ensure backup plans are in place, and comply with legal and corporate requirements. Select vendors and ensure high-quality service delivery
Relationship Management (5%): Foster environment where customers feel comfortable sharing issues and opportunities. Build and maintain strong working relationships across IT teams and customers to ensure collaboration and satisfaction. Communicate clearly and effectively while proactively managing relationships with peers and clients. Structure services to meet client needs
Leadership (5%): Inspire individuals and teams to achieve corporate and departmental objectives. Communicate vision and strategy clearly to drive success. Reinforce the desired corporate culture and hold staff accountable for performance while modeling integrity, cooperation, and strong work habits
Administration (3%): Execute routine departmental tasks, including reporting, operational metrics, RR&D program administration, and personnel-related processes such as timesheets and compensation
Financial Management (2%): Plan and monitor budgets, oversee expenditures, administer contracts, and perform monthly forecasts. Provide critical information for budget development.

What we offer

comprehensive medical, dental, and vision coverage
a strong retirement program
career development
flexible work schedules
focused on wellness
being a supportive member of the community

Fulltime

Technical Project Manager – Controls & Data Systems

We are seeking a Technical Project Manager with a strong engineering background ...

Location

United States , Northridge

Salary:

78.00 USD / Hour

Tucker Parker Smith Group

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Electrical, Biomedical, or related)
PMP certification (or equivalent) required
7 years of experience in pharmaceutical manufacturing
Experience managing technical projects in regulated or CDMO environments
Strong background in control systems, automation, and data acquisition
Knowledge of cGMP and regulatory requirements
Excellent communication, leadership, and stakeholder management skills

Job Responsibility

Lead technical projects from initiation through completion, ensuring alignment with scope, schedule, and budget
Develop and maintain project plans, risk assessments, and resource strategies
Coordinate cross-functional teams across R&D, Quality, Regulatory, and Operations
Ensure compliance with GMP, FDA, and regulatory requirements
Oversee design, implementation, and optimization of control systems and data acquisition platforms
Support technical transfer activities for pharmaceutical manufacturing programs
Guide system integration, testing, and validation efforts
Apply Quality by Design (QbD) principles and statistical tools (DoE, FMEA, Gage R&R)
Serve as the primary point of contact for clients throughout the project lifecycle
Lead project kick-offs, technical reviews, and issue resolution

Fulltime

Group Sustainability Data and Systems Manager

Boortmalt is looking for a passionate and driven Group Sustainability Manager – ...

Location

Belgium , Antwerp

Salary:

Not provided

AXEREAL SCA

Expiration Date

Until further notice

Requirements

Master’s degree in Engineering, Sustainability Management, Data Analytics, or similar
Minimum 5 years’ experience in sustainability data management, reporting, and GHG accounting
consulting or assurance experience strongly preferred
Deep knowledge of GHG Protocol (Scopes 1–3 incl. FLAG), ISO 14064, CSRD/ESRS, and external assurance requirements
Experience in LCA, product carbon foot printing or value chain emission accounting
Hands-on experience with ESG/MRV data systems and visualisation tools (Power BI or similar)
Advanced Excel/database capabilities
proficiency in data visualisation and automation tools
Strong stakeholder management, collaboration and communication skills
Fluent English (working language)

Job Responsibility

Strengthen and further build Boortmalt’s sustainability data backbone
Maintain and improve sustainability data architecture (energy, GHG, water, waste, social metrics)
Define and implement data governance standards with robust validation, processes, controls and audit trails
Administer ESG and MRV platforms and ensure consistency and integration across sites
Lead ESG/GHG reporting and assurance readiness
Consolidate Group-wide sustainability data for the Sustainability report, regulatory and voluntary disclosures (CSRD/ESRS, CDP etc.)
Develop dashboards and tools providing clear visibility on key ESG indicators for internal steering and external engagement
Calculate product environmental and carbon footprints
Manage sustainability ratings (e.g. CDP, EcoVadis) and customer sustainability questionnaires
Serve as the primary contact for auditors and assurance providers

What we offer

We offer an attractive salary and benefits package and as part of a global organization can offer career opportunities internationally
focusing on flexibility, inclusion, collaboration and health and wellbeing

Fulltime

Group Sustainability Data and Systems Manager

Boortmalt is looking for a passionate and driven Group Sustainability Manager – ...

Location

Belgium , Antwerp

Salary:

Not provided

AXEREAL SCA

Expiration Date

Until further notice

Requirements

Master’s degree in Engineering, Sustainability Management, Data Analytics, or similar
Minimum 5 years’ experience in sustainability data management, reporting, and GHG accounting
consulting or assurance experience strongly preferred
Deep knowledge of GHG Protocol (Scopes 1–3 incl. FLAG), ISO 14064, CSRD/ESRS, and external assurance requirements
Experience in LCA, product carbon foot printing or value chain emission accounting
Hands-on experience with ESG/MRV data systems and visualisation tools (Power BI or similar)
Advanced Excel/database capabilities
proficiency in data visualisation and automation tools
Strong stakeholder management, collaboration and communication skills
Fluent English (working language)

Job Responsibility

Strengthen and further build Boortmalt’s sustainability data backbone
Maintain and improve sustainability data architecture (energy, GHG, water, waste, social metrics)
Define and implement data governance standards with robust validation, processes, controls and audit trails
Administer ESG and MRV platforms and ensure consistency and integration across sites
Lead ESG/GHG reporting and assurance readiness
Consolidate Group-wide sustainability data for the Sustainability report, regulatory and voluntary disclosures (CSRD/ESRS, CDP etc.)
Develop dashboards and tools providing clear visibility on key ESG indicators for internal steering and external engagement
Calculate product environmental and carbon footprints
Manage sustainability ratings (e.g. CDP, EcoVadis) and customer sustainability questionnaires
Serve as the primary contact for auditors and assurance providers

What we offer

Attractive salary and benefits package
Career opportunities internationally
Focus on flexibility, inclusion, collaboration and health and wellbeing

Fulltime

New

Information Systems Sr. Manager – Technology Regulatory Compliance Lead

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Holly Springs

Salary:

135441.55 - 183244.45 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Information Systems/Technology and/or Engineering experience OR Master's degree and 4 years of Information Systems/Technology and/or Engineering experience OR Bachelor's degree and 6 years of Information Systems/Technology and/or Engineering experience OR Associate's degree and 10 years of Information Systems/Technology and/or Engineering experience OR High school diploma / GED and 12 years of Information Systems/Technology and/or Engineering experience

Job Responsibility

Lead the development and execution of the strategy for computer system validation, regulatory compliance, and sustained inspection readiness for the Technology organization
Serve as the Technology Regulatory Inspection Lead, ensuring alignment with global quality and compliance strategies
Drive inspection readiness efforts, including playbooks, SME coaching, system documentation, and readiness dashboards
Oversee digital platform implementations, ensuring strong planning, resource management, risk mitigation, and financial oversight
Manage digital technology services, including validation, compliance, data integrity, and system reliability
Design and implement effective support models, including vendor and third-party management with clear accountability
Lead cross-functional teams, run key meetings, and present updates to senior leadership
Deliver technology solutions that improve efficiency, quality, and business alignment
Proactively manage complex, simultaneous projects and resolve challenges effectively
Establish performance metrics to drive continuous improvement

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Sr. Manager, Air Compliance - Data and Systems

Crusoe is seeking a well-rounded and experienced Sr. Manager, Air Compliance - D...

Location

United States , Denver

Salary:

165000.00 - 180000.00 USD / Year

Crusoe

Expiration Date

Until further notice

Requirements

University degree in Engineering or related science degree (Chemical, Mechanical, or Environmental) or at least 15 years of relevant experience
Minimum of 10+ years of relevant experience
Direct experience with air quality environmental programs, with a primary focus on Title V compliance and emissions reporting, stack testing, opacity, ozone depleting substances, tanks and environmental management systems
Deep technical knowledge of federal and state air quality rules and regulations (e.g., Clean Air Act, Title V, NSPS, NESHAP)
Excellent communication skills, both written and verbal
Ability to work proactively and collaboratively as a solutions-focused team member

Job Responsibility

Act as a Subject Matter Expert for Crusoe operations, with a focus on regulations related to emissions from engines, and other combustion sources
Develop and implement processes to track and report on emissions from our operations
Verify accuracy of emission calculations and estimates
Oversee stack testing programs
Lead the development and implementation of a robust, enterprise-wide Env Management System (EMS) and training
Support Env team needs with data collection, tracking, uploads, exports, dashboards, and metrics report design
Work with internal teams to ensure key stakeholders are aware of compliance, inspection, and reporting requirements
Liaise with various regulatory agencies to facilitate compliance
Plan and assist with compliance audits and self-assessments
Facilitate air quality incident investigations and root cause analysis

What we offer

Restricted Stock Units
Health insurance package options that include HDHP and PPO, vision, and dental for you and your dependents
Employer contributions to HSA accounts
Paid Parental Leave
Paid life insurance, short-term and long-term disability
Teladoc
401(k) with a 100% match up to 4% of salary
Generous paid time off and holiday schedule
Cell phone reimbursement
Tuition reimbursement

Fulltime

Data Manager, Clinical Data Sciences

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit wit...

Location

Argentina , Buenos Aires

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Strong knowledge / understanding of clinical development and pharmaceuticals as a regulated industry
Strong knowledge / understanding of healthcare regulatory authorities (e.g. FDA, Health Canada)
Ability to learn clinical data management processes and principles in area of responsibility
Minimum 1-3 years Data Management experience required
Demonstrates required verbal and written communication skills including ability to communicate remotely
Capable to learn technical data systems
Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review)
Awareness of MedDRA/WHO-Drug preferred
Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
Bachelor’s degree minimum requirement

Job Responsibility

Participate in CDS activities including data review and query management
Assist with quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems
Ensure work carried out in accordance with applicable SOPs and working practices
Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities
Ensure operational excellence in collaboration with Data Manager and CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities

Fulltime

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Regulatory Data & Systems Manager

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