Job Title: Manager – Regulatory Transparency & Disclosure
Location: India – Hyderabad
Job ID: R-224180
Work Location Type: On-Site
Date Posted: August 29, 2025
Category: Regulatory
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and make people’s lives easier, fuller, and longer. For more than 40 years, Amgen has pioneered the biotechnology industry and continues to drive innovation by leveraging human genetic data and advanced technologies to deliver transformative medicines for millions of patients worldwide.
Lead preparation of clinical regulatory documents for public disclosure, ensuring anonymization of personal data and redaction of commercially confidential information in compliance with global regulations and company policies.
Collaborate with the Transparency & Disclosure team and cross-functional stakeholders to define redaction strategies, ensuring timely and accurate registration and results review/approval for US and EU registries.
Drive the redaction and submission process, including cross-functional review, approval, submission readiness, and timely posting.
Support continuous improvement initiatives through trend analysis and process optimization.
Manage multiple projects, coordinate team activities, and prioritize tasks to meet strict internal and external deadlines.
Serve as Process Administrator for CTRS (Clinical Trial Registration System): support active users, manage system access, resolve inquiries, and address issues.
Strong ability to interpret complex data/information and apply it effectively.
Hands-on experience with redaction/anonymization of clinical trial documents (e.g., EU CTR, HC-PRCI).
Working knowledge of clinical trial disclosures on public registries (e.g., ClinicalTrials.gov).
Excellent attention to detail, multi-tasking, and follow-through abilities.
Strong verbal and written communication skills in English.
Ability to work within controlled processes and regulatory frameworks.
Leadership and mentoring capabilities, including skills in teaching, negotiation, and influence.
Proven project management skills, with the ability to prioritize and meet deadlines.
Effective problem-solving and decision-making abilities.
Basic Qualifications:
Graduate degree with 2+ years of relevant pharmaceutical industry experience; OR
Bachelor’s degree with 4+ years of relevant pharmaceutical industry experience.
Additional Requirements:
Minimum 2 years of experience preparing regulatory documents for public disclosure.
Familiarity with international regulations, guidelines, and best practices for clinical transparency and disclosure, including personal data protection and handling commercially confidential information.
Amgen is an Equal Opportunity Employer. We are committed to providing equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We ensure reasonable accommodations are provided for individuals with disabilities during the application, interview, and employment process. Please contact us to request an accommodation.
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