Job Opportunity: Regulatory Associate
Location: India – Hyderabad
Work Type: On-site
Job ID: R-224184
Date Posted: August 29, 2025
Category: Regulatory
About Amgen
Amgen harnesses the best of biology and technology to tackle the world’s toughest diseases and improve patient lives. For over 40 years, Amgen has been a pioneer in the biotechnology industry—discovering, developing, manufacturing, and delivering innovative medicines. Today, we continue to push the boundaries of science using advanced technology and human genetic data to create transformative healthcare solutions.
Roles & Responsibilities
Prepare clinical regulatory documents for public disclosure, ensuring:
Anonymization of personal data
Redaction of commercially confidential information
Compliance with regulatory requirements and team strategies
Maintain consistent document quality and submission readiness for timely posting or submission.
Collaborate with cross-functional teams to resolve issues and escalate when necessary.
Document and maintain study/product-specific redaction strategies.
Manage timelines, coordinate tasks, and ensure deliverables meet compliance standards.
Execute clinical trial disclosure processes in alignment with regulations, company policies, SOPs, and guidance documents.
Serve as a tactical point of contact for assigned responsibilities; complete action items and maintain documentation.
Provide support during trial disclosure audits and inspections.
Act as Process Administrator for the Clinical Trial Registry System (CTRS):
Support users with system access, inquiries, and issue resolution.
Manage reports, trackers, portals, and metrics activities.
Required Skills
Strong ability to interpret and apply data/information effectively.
Self-motivated with excellent multitasking, attention to detail, and follow-through.
Ability to adhere to controlled processes.
Excellent verbal and written communication skills in English.
Strong project management and prioritization skills to meet deadlines.
Problem-solving aptitude.
Basic Qualifications
Bachelor’s degree.
Minimum 1 year of experience working with regulatory documents in a biotech/pharmaceutical setting.
Familiarity with clinical research and regulatory documentation.
Knowledge of clinical trial disclosure regulations, guidelines, and best practices.
Preferred Qualifications
Over 1 year of experience preparing regulatory documents for public disclosure.
Familiarity with systems/registries, including:
Clinical Trial Registry System (CTRS)
NIH Protocol Registration System (PRS)
ClinicalTrials.gov
EudraCT
EU CTIS, and other registries
Experience in redaction and anonymization of clinical trial documents.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. We evaluate all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We are committed to ensuring individuals with disabilities are provided reasonable accommodations during the job application process, interviews, essential job functions, and other employment benefits. To request an accommodation, please contact us directly.
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