Regulatory Data & Systems Manager
On-site · Hyderabad, Telangana, India
Job Summary
The Regulatory Data & Systems Manager will be responsible for managing IT systems, ensuring compliance with regulatory regulations, and facilitating communication among departments during the submission process. Candidates should possess strong skills in system analysis and administration, regulatory affairs, and project management. Required knowledge includes interpersonal skills, business analysis techniques, communication skills, and familiarity with GxP requirements. Preferred qualifications include advanced knowledge of Veeva Vault and experience in the Biotech or Pharmaceutical industry.
Required Qualifications
- Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 8 years of directly related experience OR High school diploma / GED and 8 years of directly related experience
- 5+ years' experience as a business analyst
- Strong interpersonal and teamwork skills
- Excellent oral and written communication skills
- Ability to operate effectively in a matrix environment
- Familiarity with GxP requirements and systems validation
- Proven Veeva Vault knowledge
Desired Qualifications
- Advanced knowledge of Veeva Vault
- Familiarity with global regulatory processes and standards
- Proficiency in Agile methodologies, including Scrum or Kanban
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