Regulatory Compliance Change Assessor – Manager
Location: Hyderabad, India (On-site)
Job ID: R-234204
Category: Regulatory Affairs / CMC Compliance
Posted Date: January 20, 2026
Employment Type: Full-Time
A leading global biopharmaceutical organization is seeking an experienced Regulatory Compliance Change Assessor – Manager to join its Regulatory Compliance team in Hyderabad. This role plays a critical part in ensuring regulatory compliance for manufacturing, quality, and supply chain changes across pharmaceutical and biotechnology products.
Reporting to the Regulatory Compliance Team Lead, the Manager will provide regulatory CMC expertise, assess global change reportability, and partner with cross-functional stakeholders to ensure compliant and efficient product lifecycle management.
Review and assess change control records to evaluate regulatory impact, global reportability requirements, and product distribution restrictions for in-scope products.
Define, document, and maintain regulatory reporting requirements and product restrictions within the change control management system.
Perform global reportability assessments for single-product and cross-product changes, based on experience level and product scope.
Interface with Global, Site, Biosimilars, and Device Regulatory Affairs CMC teams.
Collaborate closely with Operations, Process Development, Quality, and Supply Chain functions to ensure alignment on regulatory strategies.
Provide regulatory guidance and subject matter expertise to interdepartmental and cross-functional teams.
Coach, mentor, and support the professional development of junior regulatory staff.
Identify opportunities for continuous improvement and implement enhancements to change management and compliance processes.
Contribute to the development and consistent application of regulatory compliance standards and best practices.
Doctorate degree, or
Master’s degree with 4–6 years of experience in Manufacturing, QA/QC, or Regulatory CMC within the pharmaceutical or biotechnology industry, or
Bachelor’s degree with 6–8 years of relevant industry experience, or
Diploma with 10–12 years of relevant experience in Manufacturing, QA/QC, or Regulatory CMC.
Strong understanding of Regulatory CMC principles, global change management, and compliance requirements.
Experience assessing manufacturing, quality, testing, or distribution changes in a regulated pharmaceutical or biotech environment.
Ability to apply scientific, technical, and regulatory concepts to real-world product and process changes.
Proven ability to work effectively across global and cross-functional teams.
Degree in a Life Sciences discipline.
Hands-on experience with Regulatory CMC submissions and compliance strategies.
Prior experience in pharmaceutical or biotechnology manufacturing, testing (QC/QA or clinical), or product distribution.
The organization offers a collaborative and inclusive work environment, with strong support for professional development and career growth. Employees benefit from competitive compensation and comprehensive total rewards programs aligned with local industry standards.
Apply via thepharmadaily.com to advance your career in regulatory compliance and play a key role in global change management within the pharmaceutical and biotechnology industry.
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