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 global biopharmaceutical organization is seeking a Regulatory Compliance Change Assessor – Manager to join its Regulatory Compliance team in Hyderabad. This leadership role is critical to ensuring global regulatory compliance for product and process changes across pharmaceutical and biotechnology portfolios.
Reporting to the Regulatory Compliance Team Lead, the Manager will work closely with Global, Site, Biosimilars, and Device Regulatory Affairs CMC teams, as well as Operations, Quality, and Supply Chain functions. The role is responsible for assessing regulatory impact, defining global reportability requirements, and supporting compliant product lifecycle management.
Review and assess change control records to determine regulatory impact, global reportability requirements, and product distribution restrictions.
Define, document, and maintain reporting and distribution requirements within the change control management system.
Perform global reportability assessments for single-product and cross-product changes based on experience and product scope.
Liaise with Process Development, Manufacturing, Quality, and Supply Chain teams to ensure alignment on regulatory strategies.
Provide regulatory CMC expertise and guidance to interdepartmental and cross-functional stakeholders.
Coach, mentor, and support the professional development of junior regulatory staff.
Identify, recommend, and implement process improvements within the regulatory change management framework.
Promote consistent application of regulatory standards, scientific principles, and compliance 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 experience, or
Diploma with 10–12 years of experience in Manufacturing, QA/QC, or Regulatory CMC.
Strong knowledge of Regulatory CMC requirements and global change management processes.
Proven experience evaluating regulatory impact related to manufacturing, quality, testing, or distribution changes.
Solid understanding of scientific and technical standards applicable to pharmaceutical and biotechnology products.
Ability to collaborate effectively across global and cross-functional teams.
Strong analytical, communication, and stakeholder management skills.
Degree in Life Sciences or a related scientific discipline.
Hands-on experience in Regulatory CMC activities within the pharmaceutical or biotechnology industry.
Background in manufacturing, QC/QA, clinical testing, or product distribution.
A collaborative and inclusive work environment focused on innovation and patient impact.
Strong support for professional growth, leadership development, and career progression.
Competitive compensation and comprehensive total rewards aligned with industry standards.
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