PHARMAFull-time
Regulatory Intelligence Senior Specialist
HYDERABAD (IN)HYBRIDPOSTED: 9/29/2026
PHARMAFull-time
HIRING ORGANIZATIONLONZALife Sciences / Pharmaceutical Manufacturing / Healthcare Technology
ROLE OVERVIEW
Regulatory Intelligence Senior Specialist responsible for global regulatory surveillance, impact assessment, regulatory trend analysis, stakeholder collaboration, intelligence reporting, dashboards, and regulatory risk identification across human and veterinary medicines.
ROLE DEFINITION & RESPONSIBILITIES
- •Conduct global regulatory intelligence surveillance across FDA, EMA, MHRA, PMDA, Health Canada, ICH, and PIC/S
- •assess regulatory updates and potential business impact across CDMO offerings
- •collaborate with Regulatory SMEs, Quality, and cross-functional teams
- •translate complex guidance and Q&A documents into actionable summary reports
- •facilitate regulatory intelligence assessment meetings and track action items
- •maintain regulatory intelligence databases, dashboards, and metrics using Power BI or Tableau
- •maintain indexed regulatory guidance libraries and support internal training
- •identify emerging regulatory risks and opportunities across business activities
Reporting Hierarchy: Works collaboratively with global Regulatory Subject Matter Experts, Quality teams, and cross-functional stakeholders; coordinates regulatory intelligence assessment activities and tracks resulting actions across the organization
* 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 in Chemistry, Biology, Biotechnology, Pharmaceutical Science, or related field or equivalent practical industry experience
- working knowledge of global regulatory frameworks and health authority expectations
- exceptional analytical and synthesis skills
- strong organizational, project planning, and task-tracking capabilities
- ability to work EU business hours
PREFERRED QUALIFICATIONS
- •Direct Regulatory Intelligence experience in pharmaceutical or biotechnology organizations
- •experience with Power BI, Tableau, or regulatory surveillance platforms
- •experience assessing regulatory impact for CDMO operations
- •experience facilitating cross-functional regulatory assessments
REQUIRED VERIFIED SKILLS
Regulatory intelligence
regulatory surveillance
global regulatory affairs
FDA
EMA
MHRA
PMDA
Health Canada
ICH
PIC/S
regulatory impact assessment
regulatory analysis
stakeholder management
project management
Power BI
Tableau
regulatory databases
dashboard management
risk assessment
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Benefits vary by role and location; relocation assistance for eligible candidates; career development; inclusive workplace; performance-recognition programs
No compensation figures were disclosed in the provided job posting; the company notes that compensation programs recognize high performance.
ORGANIZATION CONTEXT & CULTURE
Lonza is a global life sciences company with more than 30 sites across five continents, supporting customers in developing and manufacturing medicines and therapies.
TEAM SIZE: 30,000+
INDUSTRY: Life Sciences / Pharmaceutical Manufacturing / Healthcare Technology
Culture: Collaborative, accountable, excellence-focused, inclusive, ethical, and innovation-oriented culture with emphasis on transparent knowledge sharing.
EXPECTED CAREER ROADMAP
Opportunity to deepen expertise in global regulatory intelligence, regulatory strategy, health authority requirements, cross-functional leadership, and life-sciences compliance, with potential progression into broader regulatory intelligence or regulatory affairs leadership roles.
APPLICATION ADVISORY
Highlight 5+ years of pharmaceutical experience, regulatory intelligence or regulatory affairs exposure, global health authority knowledge, analytical synthesis ability, dashboard skills, and experience converting regulatory changes into actionable recommendations. Mention EU-hours availability and cross-functional project leadership.
RECOMMENDED TRAINING
1/5
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