Lonza has announced an opportunity for experienced pharmaceutical and life sciences professionals for the position of RA RIB Surveillance Specialist in Hyderabad. This regulatory affairs and regulatory intelligence role focuses on monitoring global health authority requirements, evaluating regulatory changes, and translating complex guidance into actionable insights for Lonza’s global operations.
The Lonza RA RIB Surveillance Specialist job is particularly relevant for professionals with experience in pharmaceutical regulatory affairs, regulatory intelligence, quality, compliance, or related functions. Candidates should have 5+ years of pharmaceutical industry experience, with direct regulatory intelligence experience in pharma or biotech strongly preferred.
The position involves surveillance of major global regulatory agencies and frameworks, including the US FDA, EMA, MHRA, PMDA, Health Canada, ICH and PIC/S.
Key Responsibilities
As an RA RIB Surveillance Specialist at Lonza, the selected candidate will support global regulatory intelligence and compliance activities. Key responsibilities include:
- Conduct worldwide regulatory intelligence surveillance covering FDA, EMA, MHRA, PMDA, Health Canada, ICH and PIC/S.
- Monitor new and changing regulatory requirements, guidance documents, Q&A publications and health authority expectations.
- Perform preliminary assessments of regulatory changes to determine their potential impact on Lonza’s CDMO operations.
- Convert complex regulatory information into concise and actionable regulatory intelligence reports.
- Collaborate with global Regulatory Subject Matter Experts, Quality teams and other cross-functional stakeholders.
- Facilitate regulatory intelligence assessment meetings and document key decisions.
- Create, assign and track regulatory action items through completion.
- Maintain regulatory intelligence databases, dashboards, metrics and surveillance systems.
- Use tools such as Power BI and Tableau to improve regulatory intelligence visibility and reporting.
- Maintain an indexed internal library of relevant regulatory guidance and requirements.
- Support the development of internal regulatory intelligence training materials.
- Maintain audit-ready regulatory intelligence records and documentation.
- Develop an understanding of Lonza’s business activities to proactively identify regulatory risks and opportunities.
Eligibility and Qualifications
Candidates interested in the Lonza Regulatory Affairs Specialist job in Hyderabad should meet the following requirements:
Educational Qualification
A Bachelor’s degree or higher is preferred in one of the following or a closely related discipline:
- Chemistry
- Biology
- Biotechnology
- Pharmaceutical Science
- Other relevant scientific or life sciences disciplines
Lonza also mentions that candidates with relevant equivalent practical industry experience may be considered.
Experience Required
Candidates should have:
- 5+ years of pharmaceutical industry experience.
- Direct Regulatory Intelligence experience in pharmaceutical or biotechnology organizations is strongly preferred.
- Working knowledge of global regulatory frameworks and health authority expectations.
- Experience interpreting regulatory guidance and converting it into practical business recommendations.
This is therefore primarily an experienced-professional opportunity and not a fresher-level regulatory affairs role.
Regulatory Knowledge Required
Applicants should have working knowledge of regulatory requirements and guidance associated with major organizations such as:
- US Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- Medicines and Healthcare products Regulatory Agency (MHRA)
- Pharmaceuticals and Medical Devices Agency (PMDA)
- Health Canada
- International Council for Harmonisation (ICH)
- Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Experience monitoring changes from these authorities can be particularly valuable for this Regulatory Intelligence Specialist position at Lonza.
Technical and Analytical Skills
Candidates should possess:
- Strong regulatory intelligence and surveillance capabilities.
- Excellent analytical and synthesis skills.
- Ability to interpret complex regulatory documents.
- Ability to translate regulatory changes into practical recommendations.
- Experience with Power BI, Tableau or similar BI/dashboard tools.
- Familiarity with regulatory surveillance platforms is advantageous.
- Strong project planning and task-tracking abilities.
- Excellent organizational skills.
- Strong stakeholder communication and collaboration skills.
- Ability to work during European business hours.
- Proactive learning and sound decision-making abilities.
- Strong personal accountability and knowledge-sharing skills.
Work Location and Work Model
The actual job location is Hyderabad, India.
Lonza describes this as an office-first position designed to support close collaboration and team alignment. The job description states that employees will primarily work from the office while having flexibility to work remotely for approximately 20% of their working time.
Relocation assistance may also be available for eligible candidates and their families, subject to Lonza’s applicable policies.
Benefits of Working at Lonza
According to the job description, employees can expect:
- Agile career development opportunities.
- A dynamic working culture.
- An inclusive and ethical workplace.
- Performance-based compensation programs.
- Role- and location-dependent employee benefits.
- Opportunities to collaborate with global regulatory and quality teams.
- Exposure to worldwide pharmaceutical regulatory intelligence.
- Opportunities to contribute to global CDMO and life sciences operations.
Specific compensation and benefits may vary depending on the candidate, role and location.
Expected Salary
Lonza has not disclosed the salary range in the provided job description.
For structured-data purposes, an estimated market-aligned annual salary range of approximately ₹12,00,000–₹22,00,000 per year may be used for an experienced Regulatory Intelligence/Regulatory Affairs Specialist in Hyderabad.
Important: This is an estimated range for informational and schema purposes and should not be presented as an officially disclosed Lonza salary.
Who Should Apply?
This opportunity may be suitable for professionals currently working in areas such as:
Regulatory Affairs | Regulatory Intelligence | Global Regulatory Affairs | Regulatory Compliance | Regulatory Surveillance | Pharmaceutical Quality | Regulatory Operations
Candidates with pharmaceutical or biotech industry experience and strong exposure to global regulatory guidelines may be particularly well aligned with the position.
How to Apply
