Associate IS Business Systems Analyst - Regulatory Structured Submissions

Biopharma Careers; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amgen in India seeks an Associate IS Business Systems Analyst - Regulatory Structured Submissions to lead and contribute across the end-to-end lifecycle of regulatory submissions. You will drive SAFe/Agile practices, collaborate with cross-functional teams, and advance documentation, SOPs, and security provisioning processes.

The role requires 2–6 years of relevant experience, strong analytical skills, and excellent communication for global teams.

Qualifications

• Bachelor’s degree and 2 to 6 years of relevant experience.
• Experience with Scrum/SAFe and strong documentation skills.
• Knowledge of regulatory submissions processes is preferred.

Responsibilities

• Lead Scrum events for Regulatory Structured Submissions team and document practices.
• Collaborate to elicit and prioritize business requirements.
• Develop SOPs, design docs, diagrams, and manuals.
• Create process maps to visualize workflows and identify inefficiencies.
• Support test case creation and participate in UAT and feedback.
• Ensure security provisioning processes align with policy and training.

Skills

Scrum

SAFe

Documentation

UAT

Communication

Education

Bachelor’s degree

Tools

MS Office

Documentation tools

Regulatory tools

Job description

Career Category

Information Systems

Job Description

Join Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission, to serve patients living with serious illnesses, drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Associate IS Business Systems Analyst - Regulatory Structured Submissions

What you will do

• In this role, you will participate and lead Scrum events and processes for the Regulatory Structured Submissions Team ( Regulatory Affairs and Clinical Submissions Team). Your responsibilities include enhancing team communication and collaboration, ensuring alignment with program goals, flagging risks and dependencies, and driving continuous improvement. You will ensure the team adapts and refines SAFe principles to suit organizational needs, standardizing and documenting practices.
• The role requires a good background in the end-to-end software development lifecycle and a Scaled Agile framework practitioner, coupled with leadership and transformation experience
• Collaborating with partners to elicit, document, and prioritize business requirements.
• Develop and update technical documentation, including standard operating procedures (SOPs), design documents, operational diagrams, manuals, and more
• Developing process maps and flowcharts to visualize current processes and identify inefficiencies.
• Assisting in the creation of test cases and test plans to ensure solutions meet business requirements. Participating in user acceptance testing (UAT) and gathering feedback.
• Participating in training sessions to understand security standard processes and help educate users on security policies related to provisioning.
• Collaborating with IT, HR, and other departments to ensure smooth integration of security in provisioning workflows.
• Collaborate with business partners, Architects and Engineering teams to prioritize release scopes and refine the Product backlog.
• Lead and facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team.
• Clearly express features in User Stories/requirements so all team members and partners understand how they fit into the product backlog.
• Ensure Acceptance Criteria and Definition of Done are well-defined.
• Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops.
• Stay focused on software development to ensure it meets requirements, providing proactive feedback to partners.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with these qualifications.

Basic Qualifications

• Bachelor’s degree and 2 to 6 years of relevant experience

Must-Have Skills

• Strong problem-solving skills and the ability to analyze complex data and processes.
• Ability to create clear and detailed documentation, including specifications and process maps.
• Understanding of project management principles and methodologies (e.g., Agile, Waterfall).
• Ability to create clear and detailed documentation for processes and security protocols.

Good-to-Have Skills

• Experience with IS Security
• Proficiency in scripting and automation is a plus

Professional Certifications

• Identity Provisioning or Security Certification (preferred)

Soft Skills

• Excellent analytical and troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully
• Team oriented, with a focus on achieving team goals

Work Hours

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required. Potential Shifts (subject to change based on business requirements): Second Shift: 2:00pm – 10:00pm IST; Third Shift: 10:00 pm – 7:00 am IST.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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. Please contact us to request accommodation.