Are you passionate about regulatory compliance in the life sciences industry? Amgen, a leading biotechnology company, is looking for a Regulatory Data & Systems Associate to join their team in Hyderabad. This role provides a great opportunity to work with complex data systems while ensuring adherence to regulatory standards.
About Amgen
Amgen is a global leader in biopharmaceuticals, dedicated to unlocking the potential of biology for patients worldwide. The company focuses on innovative medicines aimed at treating serious illnesses and has a rich pipeline of products in various therapeutic areas. With a commitment to ethical business practices, Amgen strives to uphold the highest standards of quality, efficiency, and safety in all aspects of its operations.
Job Description
As the Regulatory Data & Systems Associate, you will be responsible for interpreting and carrying out business requirements based on best practices and Amgen’s regulatory processes. Your key responsibilities will include:
- Data Administration/AI: Optimize and maintain the organization’s complex data models, ensuring compliance with regulatory requirements.
- Regulatory Business Analysis: Interpret and implement regulatory guidelines, ensuring all systems and processes are compliant with industry standards.
- Project Coordination: Assist in planning, tracking, and executing departmental projects and initiatives.
- Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely communication regarding regulatory requirements and system updates.
Required Knowledge and Skills
- Strong interpersonal and teamwork skills with the ability to interact with business users, IT groups, project managers, and senior management.
- 5+ years of experience as a business analyst with a deep understanding of business analysis techniques and tools.
- Proficient in SDLC and Agile methodologies, capable of functioning effectively in a matrix environment.
- Excellent oral and written communication skills, with the ability to present ideas compellingly.
- Familiarity with GxP requirements and systems validation within the Life Sciences, Biotech, or Pharmaceutical industry.
Preferred Knowledge and Skills
- Advanced knowledge of Veeva Vault.
- Familiarity with global regulatory processes and standards.
- Proficiency in Agile methodologies, including Scrum or Kanban.
- Practical experience with regulatory data standards, such as IDMP.
- 5+ years of experience in data management, machine learning, or related fields.
Basic Education and Experience
- Bachelor’s degree + 2 years of related experience
- Associate’s degree + 6 years of related experience
- High school diploma/GED + 8 years of related experience
