Regulatory Data & Systems Manager Job at Amgen (Hyderabad)

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

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 2 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

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Senior Associate Data Management

The Senior Associate, Data Management, will help drive key business operation in...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
In depth understanding of the Veeva Vault system
Good written and verbal communication skills
Detail oriented
Independent time management and prioritization skills
Work efficiently with little support and minimal to no supervision
Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
Critical thinking skills
Appropriate software skills as required
Strong analytical and problem solving, communication and presentation skills

Job Responsibility

Responsible for maintaining data within the Regulatory Information Management (RIM) system
Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system
Serve as a Data Management SME within cross-functional collaborative initiatives
Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives
Provide support on creating, running and analysing reports for data streamline projects
Develop and deliver training materials and presentations to a global audience
Manage the protocol Amendment New Investigator (PANI) submission updates
Manage 1572 forms for FDA submission
Provide support within the global data management team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods
Adhere to Amgen processes, policies, guidelines, SOPs and training documentations

What we offer

Competitive and comprehensive Total Rewards Plans aligned with local industry standards

Data Architecture Risk Manager

The Data Architecture Risk Manager role at Citi is part of Operational Risk Mana...

Location

Poland , Warsaw

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Solid Data Architecture experience is essential
Proven experience with full cycle Risk Management challenges in a global risk organization required
Deep knowledge of data modelling, data governance, and data architecture approaches, master and reference data, operational data risks and execution
Deep knowledge of financial and risk data, along with an understanding of regulatory, compliance, risk management, and financial management concerns
Demonstrable understanding of Data fundamentals, including Data architecture, Data principles, and a deep appreciation of intersectionality and interdependency with enterprise Technology and systems architecture
Experience in overseeing complex initiatives related to global data programs in a large-scale, distributed organization
Strong track record in leading teams to deliver technical risk and control assessments and negotiate outcomes at scale
Subject matter expertise in operational risk management as applied to Data Risk
Bachelor's or Master's degree in Computer Science, Data Science, Information Technology, Business, or a related field are preferred
Certifications preferred: Certified Data Management Professional via DAMA International, Certified Data Professional via ICCP, Certified Business Intelligence Professional via The Data Warehousing Institute

Job Responsibility

Ensure Enterprise Control Standard and controls design requirements are clearly articulated and implemented consistently across Business and Function coverage teams
Execute and contribute to continuously improving Data Risk Management practices, insights and tools which are consistently embedded in day-to-day business processes and strategic decision-making of Business and Function coverage teams to enable proactive issue identification and comprehensive remediation
Oversee the compliance against ORM frameworks and oversee the effective execution of the Enterprise Data transformation
Mentor and advise on the Data Risk concepts and skills to all three lines of defense as part of ongoing execution of the operating model
Negotiate and remediate resulting risk and control concerns identified
Escalate significant or unaddressed risk issues and control environment concerns to appropriate channels
Contribute to ongoing business-as-usual activities associated to maintenance of policies, standards, and procedures as assigned

What we offer

Private Medical Care Program
Life Insurance Program
Pension Plan contribution (PPE Program)
Employee Assistance Program
Paid Parental Leave Program (maternity and paternity leave)
Sport Card
Holidays Allowance
Sport and team recreation activities
Special offers and discounts for employees
Access to an array of learning and development resources

Fulltime

Regulatory Change Management Lead

We are seeking a highly organized and experienced senior change business analyst...

Location

United Kingdom , Belfast

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Significant financial services experience, with a focus on global markets trading and investment banking operations
Demonstrated knowledge of capital markets products, including cash securities, exchange-traded derivatives, and OTC derivative products
Demonstrated knowledge of one or more non-financial regulatory reporting regulations – CASS, DP, CFTC, SEC, CSA, CAT, EMIR, SFTR, MiFID II/MiFIR, etc.
Demonstrated experience in the successful implementation of projects, operational process change and improvement
Experience in working with cross-functional teams including business management, middle office, compliance, legal and technology
Experience in collecting, defining, and documenting business and technology requirements, test plans and other project management artifacts
Experience in consulting with project stakeholders, including the skills to facilitate compromises and resolve conflicting requirements
Strong consulting and stakeholder management skills and the ability to build and foster internal relationships
Knowledge and a technical understanding of securities processing including product, process and system knowledge
Strong analytical skills and the ability to collate and make sense of large amounts of data

Job Responsibility

Support the Change Management Lead in the direct management of multiple regulatory reporting projects, ensuring alignment with strategic objectives and regulatory requirements
provide guidance and mentorship to junior team members, fostering a collaborative and high-performance culture
work closely with business functions (e.g., Operations, Middle Office, Front Office, Technology, Compliance, Legal and Finance) to execute necessary policy, process, and technology change
liaise with Business Execution and Transformation teams on topics relating to program oversight, risk monitoring, financial and administrative reporting
support the governance of program/projects including facilitation of steering committee and working groups
identify key project risks, whether stated or not, and escalate accordingly
ensure that the delivery from the workstreams/projects meets requirements and is to the appropriate quality, on time and within budget

What we offer

Generous holiday allowance starting at 27 days plus bank holidays
increasing with tenure
a discretional annual performance-related bonus
private medical insurance packages to suit your personal circumstances
employee Assistance Program
Pension Plan
Paid Parental Leave
Special discounts for employees, family, and friends
Access to an array of learning and development resources

Fulltime

Staff Product Manager - Lending Systems

At Mercury, we’re embarking on building systems from the ground up to support an...

Location

United States; Canada , San Francisco; New York; Portland

Salary:

239000.00 - 298800.00 USD / Year

Mercury

Expiration Date

Until further notice

Requirements

10+ years of product management or aligned experience
at least 4+ years in lending, credit, or financial systems
experience building complex systems or platforms from scratch in a fintech or financial services environment
strong understanding of lending lifecycles (origination, underwriting, servicing, repayment) and associated risk/compliance considerations
technical fluency
ability to dive deep with engineers while simplifying complexity for business and compliance stakeholders
a systems mindset - seeing lending not just as features but as interconnected flows of data, risk, operations, and customer experience
proven ability to balance customer empathy with rigorous business, compliance, and operational requirements
track record of delivering internal platforms or tools that enable speed, scalability, and efficiency across teams
comfort operating in ambiguity and setting direction in greenfield product areas

Job Responsibility

Define the vision, strategy, and roadmap for Mercury’s lending systems and infrastructure
Build the core platform that powers loan origination, underwriting, servicing, and repayment across a range of lending products
Partner with engineering, risk, design, data science, and operations to design scalable systems that balance automation with resilient controls
Establish the technical and product foundations to support new credit and lending products, including decisioning workflows, data integrations, repayment rails, and compliance features
Collaborate with banking partners and internal stakeholders to ensure lending products are regulatory-compliant and operationally sound
Prioritize areas of investment using customer insights, market research, and data-driven decision-making
Set and track success metrics for lending system health, adoption, and customer impact
Create reusable capabilities that amplify the speed and consistency of launching future lending products

What we offer

equity
benefits

Fulltime

Lead Product Manager, Data and Machine Learning (ML)

As a Lead Data and Machine Learning Product Manager, you’ll own the vision, stra...

Location

United States , New York

Salary:

200000.00 - 230000.00 USD / Year

Clear

Expiration Date

Until further notice

Requirements

8+ years of product management experience, ideally owning data platforms, ML-powered features, or analytics products
Strong fluency in data infrastructure, machine learning workflows, and responsible AI concepts
Experience delivering end-user and partner-facing features (e.g. personalization, core identity, insights, fraud detection)
Skilled in partnering with Data, Engineering, and Security teams to ship performant, privacy-safe, and compliant systems
Adept at leading cross-functional teams, navigating ambiguity, and driving from vision to execution
Excellent communication skills
able to explain complex concepts to technical and non-technical audiences alike
Deep curiosity and user-first mindset, with a passion for unlocking value through intelligence

Job Responsibility

Define and own the product strategy and roadmap for CLEAR’s data and ML-powered capabilities, spanning internal intelligence platforms and customer/partner-facing use cases
Lead the design and delivery of systems that support ML model development, deployment, and monitoring, in partnership with Engineering and Data teams
Define and evolve reporting and analytics capabilities, helping us understand and optimize user identity verification, usage, and conversion
Work closely with stakeholders across Engineering, Data, Security, Product, GTM, and Ops to ensure robust, compliant, and scalable solutions
Translate regulatory requirements (e.g. GDPR, CCPA) into data handling features that preserve trust and transparency
Set clear KPIs and success metrics, and use them to inform prioritization, iteration, and impact storytelling

What we offer

Hybrid work environment
Meals and snacks in offices
Well-being and learning & development stipend and reimbursement programs
Comprehensive healthcare plans
Family building benefits (fertility and adoption/surrogacy support)
Flexible time off
Free OneMedical memberships for you and your dependents
401(k) retirement plan with employer match
Annual bonuses
Commission

Fulltime

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...

Location

Italy , Bologna; Milano; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong organizational skills, attention to detail, and ability to manage priorities
Collaborative mindset and effective communication with team members and stakeholders
Ability to operate independently on clearly defined assignments
Proficiency in Microsoft Office Suite and regulatory submission/document management tools
Fluent in English, both written and spoken

Job Responsibility

Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
Provide and review regulatory assessments for change controls and product updates
Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
Provide critical review of documentation supporting regulatory applications
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Support other relevant assignments as directed by supervisor

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

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Regulatory Data & Systems Manager

Job Description

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