Jobs

Interviews
Job Alerts
Tools

Upskill and Grow with AI

Mock Interview Practice interviews in realistic simulations

Coding Practice Improve your coding skills with challenges

Certification Earn certifications to validate your skills

AI Learning Get trained with AI expert sessions

Career Path AI insights for smarter career decisions

AI Job Match Score AI-Powered Job Match Against Your Resume and Optimize Your Resume

Career Tools and Resources

Resume Builder Build Professional Resume with Ease

ATS Friendliness Check Check Resume Friendliness for Applicant Tracking Systems

Auto Apply Apply to hundreds of jobs on any platform effortlessly

Co-Pilot (Chrome Extension) Your AI Assistant for Seamless Browsing Efficiency

Interview Questions Streamline interviews with ready-to-use questions

Salaries Discover market-driven salary insights across skillsets and geographies

Companies Explore leading companies actively hiring talent
For Employers

Home
>
Jobs in Hyderabad
>
Amgen Inc
>
Regulatory Data & Systems Manager

Job Expired: This job listing has expired.

Regulatory Data & Systems Manager

Amgen Inc

5 - 10 years

9 - 13 Lacs

Hyderabad

Posted:8 months ago| Platform:

Apply

Skills Required

project management veeva system analysis regulatory affairs agile methodology kubernetes sfdc business analysis docker ansible sql salesforce salesforce crm system administration autodesk inventor java git kanban jenkins scrum agile aws sdlc vault

Work Mode

Work from Office

Job Type

Full Time

Job Description

About The Role The Regulatory Data & Systems Manager will be responsible for facilitating system administration tasks and interpreting requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves managing and optimizing complex systems, ensuring compliance with regulatory regulations and guidance, and facilitating effective communication between various departments involved in the submission process. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs, and project management.Roles & Responsibilities:

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.

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.

Proven Veeva Vault knowledge.

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:

Bachelor’s degree and 2 years of directly related experience

Associate’s 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 administering large scale enterprise systems in the Biotech/Pharmaceutical industry

More Jobs at Amgen Inc

Strategic Planning & Operations Senior Manager

Hyderabad

5 - 10 yrs

INR 7 - 12 Lacs

IT Project Manager / SAFe Scrum Master

Hyderabad

5 - 6 yrs

INR 7 - 10 Lacs

CSAR Manager - SAS Edit Check Programmer

Hyderabad

9 - 12 yrs

INR 20 - 27 Lacs

Global HEOR Economic Modeling Leader

Hyderabad

4 - 8 yrs

INR 15 - 18 Lacs

Cyber and 3rd party risk manager

Hyderabad

6 - 9 yrs

INR 11 - 15 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Business Analysis Interview

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.

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

Enhance Your Java Skills

Practice Java coding challenges to boost your skills

Start Practicing Java Now

Amgen Inc

Biotechnology

Thousand Oaks

Login to

Please Verify Your Phone or Email

Confirm Action

Regulatory Data & Systems Manager