Sr Associate Software Engineer – Regulatory Structured Submission

Amgen; Hyderabad; On-site; INR 1,200,000 - 1,900,000; Full time

Job summary

Amgen is seeking a Sr Associate Software Engineer – Regulatory Structured Submission to automate regulatory content using VBA on a GxP platform. The role emphasizes VBA development, Appian familiarity, and MS Office automation, with collaboration across regulatory stakeholders to meet stringent standards.

The ideal candidate has 5–9 years of related experience, strong problem-solving, and communication skills, and a background in the pharmaceutical industry and Agile practices.

Qualifications

• Master’s or Bachelor’s degree with 5–9 years of relevant experience.
• Experienced in VBA Development, Appian programming, MS Office Macros and MS Office automation.
• Experience engaging Business stakeholders for requirements and feedback.
• 4–5 years in the Pharmaceutical Industry is good to have.
• Strong problem-solving, communication, and ability to work with senior leadership.
• Familiar with Agile software development (Scrum) and modern web app requirements.

Responsibilities

• Develop VBA automation for regulatory content on a GxP platform.
• Review and enhance existing VBA code, add features, and improve efficiency.
• Collaborate with regulatory experts to gather requirements and ensure regulatory alignment.
• Document code and processes for maintainability and knowledge transfer.
• Provide expert technical support in validation to optimize quality and cost.

Skills

VBA Development

Appian programming

MS Office macros

MS Office automation

Stakeholder engagement

Agile Scrum

Pharma industry experience

Problem solving

Communication skills

Requirements writing

DevOps basics

Education

Master’s/Bachelor’s degree

Tools

Appian

MS Office

Job description

Career Category

Information Systems

Job Description

Join Amgen’s Mission of Serving Patients

At 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.

Sr Associate Software Engineer – Regulatory Structured Submission

What you will do

We are seeking an experienced VBA Automation Developer to work on a GxP platform supporting the automation of regulatory content. A proficient VBA developer should have a solid understanding of VBA programming and MS Office macro working, including syntax, functions, and debugging techniques. The ability to automate repetitive tasks using VBA, including creating macros to streamline processes and improve efficiency, is essential. Experience in designing user-friendly interfaces within MS Office applications, including creating forms, buttons, and other interactive elements, is valuable. Proficiency in implementing robust error handling and debugging techniques to ensure code reliability and maintainability is crucial. The ability to document code and processes clearly, ensuring that others can understand and maintain the codebase, is necessary. Strong analytical and problem-solving skills to identify issues and develop effective solutions are also required.

• Familiarity with MS Word templates and Appian programming
• Ability to review and analyze existing VBA code to understand its structure and functionality.
• Skills in customizing and enhancing existing code to meet new requirements, including adding new features and modifying existing ones.
• Proficiency in testing and validating changes to ensure they meet the specified requirements and do not introduce new issues.
• Ability to work collaboratively with stakeholders, including regulatory experts, to gather requirements and ensure that changes align with regulatory standards.
• Solid understanding of Visual Basic language, including syntax, functions, and debugging techniques.
• Ability to automate repetitive tasks using VBA, including creating macros to streamline processes and improve efficiency.
• Proficiency in implementing robust error handling and debugging techniques to ensure code reliability and maintainability.
• Ability to document code and processes clearly, ensuring that others can understand and maintain the codebase.
• Strong analytical and problem-solving skills to identify issues and develop effective solutions.
• Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms.

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:

• Master’s degree / Bachelor’s degree and 5 to 9 years of relevant experience

Must-Have Skills:

• Experienced in VBA Development, Appian programming, MS Office Macros and MS Office automation.
• Experience of engaging with Business stakeholders for gathering requirements, demonstrating the capabilities developed and taking feedback for continual improvement.
• Good to have 4-5 years of experience in the Pharmaceutical Industry
• Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology
• Experience with Agile software development methodologies (Scrum)
• Good communication skills and the ability to work with senior leadership with confidence and clarity
• Experience in writing requirements for development of a modern web application
• Proficiency in automation tools, data systems, and validation software.

Good-to-Have Skills:

• Demonstrated expertise in a scientific domain area and related technology needs
• Understanding of scientific software systems strategy, governance, and infrastructure
• Familiarity with low-code, no-code test automation software
• Technical thought leadership
• Able to communicate technical or complex subject matters in business terms
• Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology

Professional Certifications:

• SAFe for Teams certification (preferred)

Soft Skills:

• Able to work under minimal supervision
• Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work
• Excellent analytical and gap/fit assessment 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
• Strong presentation and public speaking skills

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.

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