Amgen Hiring For Multiple Roles in Regulatory Affairs

Amgen, a leading biotechnology company, is actively seeking to expand its team in Hyderabad, India. They’re currently hiring for two roles: a Sr. Associate Regulatory Affairs and a Regulatory Data & Systems Senior Associate.

Sr. Associate Regulatory Affairs

The Senior Associate Regulatory Affairs role focuses on the Chemistry, Manufacturing, and Controls (CMC) aspect of regulatory affairs. This means the person in this role will be responsible for ensuring compliance with all regulations related to product manufacturing and quality, including the product lifecycle.

Job Responsibilities:

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• Submission Lead: The primary responsibility of this role is to lead submission for annual reports, facility registrations, facility renewals, and product renewals.
• Document Management: They will need to interact with authors, reviewers, and subject matter experts to prepare and organize CMC documents. This requires a strong understanding of how to prepare submission content plans, and a good understanding of the process.
• Submission Support: They will support the preparation of submission content plans for CMC submissions, including CMC IND/CTAs and amendments, new marketing applications, facility registrations, post-market supplements/variations, product renewals, and annual reports.
• Document Archiving: They must keep records of all CMC submissions and related communications in a document management system.
• Project Management: The individual will need to initiate and maintain CMC product timelines, ensuring projects stay on track.
• Team Interface: They will interface with the regulatory operations team, and potentially train other staff members.
• Reporting: The position includes reporting the status of activities and projects to teams and the department.

Basic Qualifications:

• Education: A Master’s degree is required.
• Experience: 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 1-2 years of experience. Associate’s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience.

Preferred Qualifications:

• Education: A BS degree in Life Science is preferred.
• Experience: Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development is highly valued. Regulatory CMC-specific knowledge and experience are also a plus.
• Skills: This person should possess strong project management and organizational skills, as well as excellent communication skills. Experience with Veeva Vault platforms is also beneficial.

Regulatory Data & Systems Senior Associate

This role is focused on the intersection of regulatory affairs and data management. This role will be responsible for optimizing complex data systems, ensuring compliance with regulations. This individual will use their skills in system analysis and data science/AI to manage data and support health authority submissions.

Roles & Responsibilities:

• Data Administration/AI: Optimize and maintain data models, ensuring they are integrated, efficient, and compliant.
• Regulatory Business Analysis: Translate regulatory requirements into actionable plans and ensure systems and processes adhere to regulations and best practices.
• Project Coordination: Assist with departmental projects and initiatives.
• Stakeholder Communication: Communicate regulatory requirements and system updates to internal and external stakeholders.

Required Knowledge and Skills:

• Interpersonal Skills: Strong interpersonal and teamwork skills.
• Experience: 5+ years of experience as a business analyst.
• Skills: Excellent oral and written communication skills.
• Ability to operate effectively: Able to work in a matrix environment and work independently.
• Familiarity with GxP requirements: Strong experience with GxP requirements and systems validation.
• Industry Experience: Experience in the Life Sciences, Biotech, or pharmaceutical industry.

Preferred Knowledge and Skills:

• Veeva Vault: Advanced knowledge of Veeva Vault.
• Regulatory Process: Familiarity with global regulatory processes.
• Agile Methodologies: Proficiency in Agile methodologies, such as Scrum or Kanban.

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:

• Experience with regulatory data standards.
• 5+ years’ experience in data management, machine learning.

Why Work at Amgen?

Amgen offers a dynamic and innovative environment where you can contribute to groundbreaking advancements in medicine. They provide opportunities for career growth, skill development, and the chance to make a real difference in the lives of patients. As a leader in the biotechnology industry, Amgen offers a culture of innovation, collaboration, and a commitment to scientific excellence.

How to Apply:

Interested candidates can apply through the Amgen career website, using the job requisition IDs listed above. This is a chance to be part of a company that is at the forefront of biotechnology, impacting global healthcare..

Application Link For Associate Regulatory Affairs (Freshers – 5 Years)

Application Link For Regulatory Data & Systems Senior Associate