Associate Regulatory Writing Vacancy | Amgen | Hyderabad

Apply now for Associate Regulatory Writing role at Amgen, Hyderabad. Openings for candidates with 1+ year experience in clinical regulatory documents.

Amgen, a global biotechnology leader, is hiring Associate Regulatory Writing professionals at its Hyderabad office. This role is ideal for candidates with experience in regulatory documentation, clinical research, and disclosure regulations who want to advance their careers with one of the world’s top biopharmaceutical innovators.

Company Overview

Amgen has been a pioneer in the biotechnology industry for over 40 years, leveraging human genetics, advanced biology, and cutting-edge technology to develop life-saving therapies. With a mission to improve lives worldwide, Amgen delivers innovative medicines to millions of patients suffering from some of the world’s toughest diseases. The company emphasizes collaboration, innovation, and inclusion, making it a top choice for professionals in the pharma and biotech sectors.

Job Role & Responsibilities

As an Associate Regulatory Writer at Amgen, you will:

• Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information.
• Ensure consistent document quality and submission readiness.
• Collaborate with cross-functional teams to resolve issues and maintain documentation.
• Manage disclosure timelines and ensure compliance with global regulations, Amgen policies, SOPs, and guidance.
• Record and maintain redaction strategies for studies and products.
• Assist/support trial disclosure audits and inspections.
• Serve as a process administrator for Clinical Trial Registry Systems (CTRS) and support users with access, issue resolution, and inquiries.
• Generate and manage reports, trackers, portals, and metrics.

Eligibility / Qualifications

• Basic Requirements:
  • Bachelor’s degree.
  • Minimum 1 year of experience working with regulatory documents in a biotech/pharma environment.
  • Familiarity with clinical research and regulatory documents.
  • Strong knowledge of clinical trial disclosure regulations, guidelines, and best practices.
• Preferred Requirements:
  • Over 1 year of experience in preparing regulatory documents for public disclosure.
  • Familiarity with Clinical Trial Registry Systems (CTRS), NIH PRS, ClinicalTrials.gov, EudraCT, and EU CTIS.
  • Experience in document redaction and anonymization.
• Skills:
  • Strong problem-solving, project management, and organizational skills.
  • Attention to detail and ability to follow controlled processes.
  • Excellent communication skills in English (written and spoken).

Location & Salary

• Location: Hyderabad, India (On-site).
• Salary: Competitive salary with comprehensive benefits, training, and career development opportunities.

Application Process

Interested candidates can apply online through Amgen’s official career portal:
Apply Here

Why Join Amgen?

• Work with a global pioneer in biotechnology with a mission-driven culture.
• Contribute to clinical trial transparency and regulatory compliance.
• Gain exposure to international clinical research and regulatory systems.
• Benefit from career growth, training, and inclusive workplace policies.

FAQs

1. What experience is required for this role?
At least 1 year of experience in regulatory writing within pharma/biotech environments.

2. What qualifications are needed?
A bachelor’s degree in life sciences or related fields with regulatory experience.

3. Is prior disclosure experience mandatory?
Not mandatory, but prior experience in regulatory disclosure and redaction is preferred.

4. Where is the role based?
On-site at Amgen’s Hyderabad location.

5. How can I apply?
Apply online via Amgen’s official portal: Apply Here

Call to Action

Take the next step in your regulatory writing career with Amgen. Apply today to join a global biotech leader driving innovation in healthcare. Submit your application now and secure your chance to work with one of the best in the industry!

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