PHARMAFull-time
Regulatory Intelligence Senior Specialist
By Admin · Regulatory Affairs
HYDERABAD (IN)HYBRIDPOSTED: 9/29/2026
PHARMAFull-time
HIRING ORGANIZATIONLONZALife Sciences / Pharmaceutical Manufacturing / Healthcare Technology
ROLE OVERVIEW
Drive global regulatory intelligence surveillance and analysis across human and veterinary medicines, translating changing health authority requirements into actionable insights that support compliance, risk management, and Lonza's global CDMO operations.
ROLE DEFINITION & RESPONSIBILITIES
- •Conduct worldwide regulatory intelligence surveillance covering FDA, EMA, MHRA, PMDA, Health Canada, ICH, and PIC/S
- •Partner with Regulatory SMEs, Quality, and cross-functional teams to assess operational applicability of regulatory updates
- •Monitor guidance documents and Q&A texts and convert complex requirements into clear actionable summaries
- •Facilitate cross-functional regulatory intelligence assessment meetings and track resulting action items to completion
- •Maintain regulatory intelligence databases, dashboards, metrics, and audit-ready information using tools such as Power BI or Tableau
- •Maintain an indexed library of regulatory guidance and support internal regulatory intelligence training
- •Develop knowledge of Lonza business activities to proactively identify regulatory risks and opportunities
Reporting Hierarchy: Works with global Regulatory Subject Matter Experts, Quality, and cross-functional stakeholders; Facilitates cross-functional regulatory intelligence assessment meetings and coordinates regulatory action tracking
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- 5+ years of pharmaceutical industry experience
- Bachelor's degree or higher preferred in Chemistry, Biology, Biotechnology, Pharmaceutical Science, or equivalent practical industry experience
- Working knowledge of global regulatory frameworks and health authority expectations
- Strong analytical and synthesis skills
- Experience with BI/dashboard tools such as Power BI or Tableau or regulatory surveillance platforms
- Strong organizational, project planning, and task-tracking skills
- Ability to work EU business hours
PREFERRED QUALIFICATIONS
- •Direct Regulatory Intelligence experience in pharma or biotech
- •Experience with global cross-functional teams
- •Regulatory surveillance platform experience
- •Experience developing regulatory intelligence training materials
REQUIRED VERIFIED SKILLS
Global regulatory intelligence
regulatory surveillance
FDA
EMA
MHRA
PMDA
Health Canada
ICH
PIC/S
regulatory impact assessment
regulatory analysis
regulatory guidelines
regulatory databases
Power BI
Tableau
project management
pharmaceutical industry
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Compensation programs recognizing high performance; benefits dependent on role and location; agile career and dynamic working culture; inclusive and ethical workplace
The source does not disclose a specific salary range or bonus/equity amount. Compensation is described as performance-oriented, with benefits varying by role and location.
ORGANIZATION CONTEXT & CULTURE
Lonza is a global life sciences and CDMO organization with more than 30 sites across five continents, supporting customers in turning breakthrough ideas into viable therapies and manufacturing medicines of the future.
TEAM SIZE: Global organization with 30+ sites across five continents
INDUSTRY: Life Sciences / Pharmaceutical Manufacturing / Healthcare Technology
Culture: Lonza emphasizes Collaboration, Accountability, Excellence, Passion, and Integrity, with a strong focus on inclusion, knowledge sharing, global teamwork, and innovation.
EXPECTED CAREER ROADMAP
The role can progress toward Regulatory Intelligence leadership, global regulatory strategy, regulatory affairs management, or broader regulatory and compliance leadership roles within a global life sciences and CDMO organization.
APPLICATION ADVISORY
Emphasize 5+ years of pharmaceutical industry experience and any direct Regulatory Intelligence work; highlight knowledge of FDA, EMA, MHRA, PMDA, Health Canada, ICH, and PIC/S; demonstrate experience translating complex regulations into actionable business recommendations; showcase Power BI/Tableau or regulatory surveillance platform experience; mention cross-functional meeting leadership and action tracking; demonstrate ability to work EU business hours.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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