Amgen Life Science Jobs as Associate in Regulatory Writing, Hyderabad – Apply now!
About the Company
Amgen Inc., established in 1980 as Applied Molecular Genetics, is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California. As one of the world’s largest independent biotechnology firms, Amgen employs approximately 24,000 staff globally as of 2022. The company specializes in human therapeutics, developing treatments for conditions such as severe asthma, plaque psoriasis, and small-cell lung cancer. Amgen’s product portfolio includes notable medicines like Epogen, Neupogen, Enbrel, and Prolia. With a commitment to unlocking the potential of biology for patients suffering from serious illnesses, Amgen continues to focus on innovative research and development in biotechnology.
Job Title: Associate, Regulatory Writing
Location: India – Hyderabad
Career Category: Regulatory
Job Type: Full time
Posted: Yesterday
Job ID: R-210834
Job Description:
Roles and Responsibilities:
- Performs document-level Quality Control (QC) to ensure submission readiness quality
- Ensures consistency and accuracy in documents, applying Amgen submission formatting guidelines
- Coordinates document collection and ensures publishing readiness
- Participates in collaborative team activities for document review
- Participates in project management activities and attends cross-functional meetings
- Uses required authoring tools and technology platforms
- Complies with SOPs, best practices, and Regulatory Writing Style Guides
- Compiles and maintains product-specific reference libraries
Basic Qualifications:
- Graduated with a Bachelor’s degree in science
Preferred Qualifications:
- 1-2 years of experience in regulatory/clinical documents management
- Scientific or medical knowledge
- Exposure to basic statistical and medical communication principles
- Strong oral and written communication skills
- Able to work independently and collaboratively
- Attention to detail and accuracy
- Strong organizational and time management skills
- Knowledge of document management systems and office applications
Keywords: Associate Regulatory Writing, Regulatory Job, Clinical Documents, Pharma, Biotech, Hyderabad, Full Time, Amgen Lifescience jobs. Amgen Life Science Jobs as Associate in Regulatory Writing, Hyderabad – Apply now!
