Amgen Hiring for Associate Regulatory Writing in Hyderabad. Apply online for regulatory jobs in India. On-site opportunity with top biotech company.
About Amgen
Amgen is a leading biotechnology company that combines the power of biology and technology to transform the lives of millions of patients worldwide. Founded over 40 years ago, Amgen helped establish the biotechnology industry and continues to lead through innovation, science, and a deep commitment to improving global health. The company’s primary goal is to fight some of the toughest diseases in the world and make people’s lives healthier, fuller, and longer. Amgen Hiring for Associate Regulatory Writing
With decades of experience, Amgen remains at the forefront of cutting-edge research and development, leveraging advanced technologies and human genetic data to discover and deliver innovative medicines. Its mission is built on scientific integrity, a strong ethical foundation, and a dedication to patients’ well-being. If you are passionate about contributing to meaningful medical advancements and want to work with a global leader in biotechnology, this is an excellent opportunity to join Amgen’s growing team in India. Amgen Hiring for Associate Regulatory Writing
Position: Associate Regulatory Writing
Job ID: R-224183
Location: Hyderabad, India
Work Type: On-site
Category: Regulatory
Date Posted: August 29, 2025
Role Overview
Amgen is currently seeking an Associate Regulatory Writing professional for its Hyderabad location. This position is ideal for individuals who are detail-oriented, have a strong understanding of regulatory documentation, and are passionate about ensuring compliance with clinical and regulatory standards. Amgen Hiring for Associate Regulatory Writing
As an Associate Regulatory Writer, you will play a vital role in preparing clinical regulatory documents for public disclosure. This includes anonymizing personal data, redacting commercially confidential information, and ensuring that all documentation meets global regulatory requirements. You will collaborate closely with cross-functional teams to ensure accuracy, consistency, and submission readiness of all regulatory documents.
This position offers a dynamic environment where you will be responsible for multiple projects simultaneously, working within structured timelines and processes. You will also contribute to maintaining the company’s reputation for regulatory excellence and data transparency. Amgen Hiring for Associate Regulatory Writing
Key Roles and Responsibilities
- Preparation of Regulatory Documents
- Prepare clinical regulatory documents for public disclosure, ensuring compliance with both local and international regulatory requirements.
- Anonymize personal data and redact sensitive or commercially confidential information as required by law and internal policies.
- Ensure all regulatory documentation aligns with the company’s strategy and submission standards.
- Quality Assurance and Submission Readiness
- Maintain consistent quality across all documents and ensure each document is fully submission-ready.
- Coordinate with cross-functional teams to ensure timely handoffs for submission or posting to the relevant portals.
- Cross-Functional Collaboration
- Work closely with clinical, regulatory, and data disclosure teams to resolve documentation-related issues.
- Escalate concerns promptly and ensure efficient communication between departments.
- Documentation Management
- Record and maintain written redaction strategies for studies and products.
- Manage timelines efficiently, coordinate work distribution, and track progress across team members.
- Compliance and Business Process Execution
- Execute Amgen’s clinical trial disclosure business processes in line with global regulations, company policies, and SOPs.
- Ensure deliverables are completed within the defined timelines.
- Audit and Inspection Support
- Assist and support trial disclosure audits and inspections.
- Maintain detailed documentation and ensure audit readiness at all times.
- System and Process Administration
- Serve as Process Administrator for the Clinical Trial Registry System (CTRS).
- Support active CTRS users, manage system access, and resolve technical or procedural issues.
- Generate, manage, and maintain reports, trackers, portals, and other metric-related activities for internal review.
Required Skills and Competencies
- Strong ability to interpret, analyze, and apply data/information in a practical, regulatory-compliant manner.
- Excellent command of written and spoken English, with the ability to produce clear, accurate, and concise documentation.
- High attention to detail, strong follow-through, and ability to multitask effectively in a fast-paced environment.
- Sound understanding of controlled document processes and compliance requirements.
- Strong project management skills with the ability to prioritize work to meet strict deadlines.
- Excellent problem-solving ability and a proactive approach to issue resolution.
- A collaborative mindset with the ability to work effectively in a cross-functional, multicultural team.
Basic Qualifications
- Bachelor’s degree in any relevant field.
- Minimum of 1 year of experience working with regulatory documents in the biotechnology or pharmaceutical industry.
- Familiarity with clinical research and clinical regulatory document preparation.
- Understanding of clinical trial disclosure regulations, guidelines, and best practices.
Preferred Qualifications
- More than one year of experience preparing regulatory documents for public disclosure.
- Familiarity with systems and registries such as:
- Clinical Trial Registry System (CTRS)
- NIH Protocol Registration System (PRS)
- ClinicalTrials.gov
- EudraCT
- EU CTIS
- Hands-on experience with redaction and anonymization of clinical trial documents.
- Working knowledge of international disclosure regulations and document submission standards.
Why Join Amgen?
Working at Amgen offers you the chance to contribute to groundbreaking scientific innovation while growing your professional career in a supportive and inclusive environment. As part of one of the world’s most respected biotechnology companies, you will have access to advanced resources, industry-leading technologies, and opportunities to collaborate with experts in various fields. Amgen Hiring for Associate Regulatory Writing
Amgen values curiosity, accountability, and teamwork. You will be encouraged to take initiative, bring fresh ideas, and play a key role in driving regulatory excellence. Moreover, Amgen emphasizes continuous learning and career development, offering employees the tools they need to succeed and progress. Amgen Hiring for Associate Regulatory Writing
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. The company ensures that all qualified applicants are considered without discrimination on the basis of race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, or disability. Amgen Hiring for Associate Regulatory Writing
Amgen is committed to providing reasonable accommodation for individuals with disabilities throughout the recruitment process, during employment, and in accessing benefits or privileges. Applicants who require assistance or accommodation are encouraged to contact Amgen’s HR team for support. Amgen Hiring for Associate Regulatory Writing
Location and Work Environment
- City: Hyderabad, India
- Work Type: On-site
- Job Category: Regulatory
- Job ID: R-224183
The Hyderabad site provides a collaborative environment that fosters innovation and teamwork. Employees have access to advanced research facilities, a professional workspace, and ongoing opportunities for skill enhancement. Amgen Hiring for Associate Regulatory Writing
How to Apply
Interested and eligible candidates can apply online for the Associate Regulatory Writing position at Amgen by visiting the official careers page. Follow the steps below: Amgen Hiring for Associate Regulatory Writing
- Visit the Amgen Careers Portal at https://careers.amgen.com
- In the search bar, enter Job ID: R-224183 or search for “Associate Regulatory Writing – Hyderabad.”
- Review the detailed job description and eligibility requirements.
- Click on “Apply Now” and create an account or log in if you already have one.
- Complete the online application form, upload your updated resume, and submit your application.
Applicants are encouraged to apply as soon as possible to ensure consideration for this opportunity. Amgen Hiring for Associate Regulatory Writing
Conclusion
The Associate Regulatory Writing position at Amgen India, Hyderabad, offers a valuable opportunity to build your regulatory career within a globally renowned biotechnology organization. If you possess the right skills, passion for compliance, and interest in contributing to medical advancements, this role could be a perfect fit for you. Join Amgen and be part of an innovative team that is shaping the future of healthcare and making a real difference in patients’ lives. Amgen Hiring for Associate Regulatory Writing
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