Regulatory Data & Systems Senior Associate Amgen

2.0 - 8.0 years

0 Lacs

hyderabad, telangana

On-site

The Regulatory Data & Systems Senior Associate will be responsible for interpreting and executing business requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves optimizing complex data systems supporting the health authority submission process, while ensuring compliance with regulatory regulations and guidance. The ideal candidate will have a strong background in system analysis and data science/AI in a regulated industry. Roles & Responsibilities: Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, 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. Required Knowledge and Skills: 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 Knowledge and Skills: Advanced knowledge of Veeva Vault. Familiarity with global regulatory processes and standards. Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment. Basic Education and Experience: Bachelors degree and 2 years of directly related experience. Associates degree and 6 years of directly related experience. High school diploma/GED and 8 years of directly related experience. Preferred Education and Experience: Practical experience with regulatory data standards, such as IDMP. 5+ years experience in data management, machine learning, or related fields.,

Posted 1 week ago

Apply

Risk & Compliance Expert - Controls Assurance Sanofi EU

2.0 - 6.0 years

0 Lacs

hyderabad, telangana

On-site

The Digital Risk & Compliance Expert Controls Assurance will be responsible for driving the execution of assessment and testing campaigns such as GxP Periodic Reviews & Third Party Assessments within the Digital Risk & Compliance team. Your impact will extend beyond the team as you support the Digital transformation objective of halving the time from discovery to therapy by ensuring Risk & Compliance at the speed of the business. In this role, you will have the opportunity to work in an international environment as part of a dynamic team, empowered to propose and implement innovative ideas. You will collaborate with diverse business teams and vendors, gaining hands-on experience and contributing to the improvement of controls mitigating Digital risks. Your main responsibilities will include conducting activities related to the execution of GxP Periodic Reviews with a critical thinking mindset, supporting the operational elements of the process, identifying compliance risks, evaluating designed controls, and leading the improvement process. Additionally, you will be involved in supporting the execution of third party quality assessments and audits, identifying compliance risks, evaluating controls, and presenting findings to the Third Party Audit team. The role requires a Bachelor's degree in a scientific, engineering, or Digital/IT discipline, along with 4+ years of experience in Audit/Quality Assurance/inspection in regulated GxP computerized systems environments. You should also have 4+ years of experience in Quality Management, Computerized Systems compliance, or Information Technology contributing to regulated projects, in addition to 2+ years of experience working in the Life Sciences industry. Soft skills such as stakeholder management, adaptability, critical-thinking, problem-solving, leadership, communication, and relationship-building are essential. You should be results-driven, proactive, autonomous, and have a high level of assertiveness. Technical skills required include Audit/Quality Assurance/inspection experience, understanding of relevant life sciences IT risk domains and controls, knowledge of quality management & compliance, industry standards, and IT lifecycle approaches. Fluency in English is mandatory for this position, and you will be expected to demonstrate behaviors like Stretch, putting the interest of the organization first, acting in the interest of patients and customers, and taking action. Skills such as Strategic Thinking, Result Orientation, Relationship, and Influence will also be assessed during the interview process.,

Posted 1 week ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.