100% Free · Space Solutions International (Pvt) Ltd
EducationalCareerGovernmentAfter O/LAfter A/LSkillsBudgetEntrepreneurStudent LoansForecastJob PortalAI Career Test

Biosafety & Regulatory Affairs Manager

HIGH DemandLOW AI RiskGROWING in SL· Rs.125k+ /mo

About This Role

Oversees the safe handling of GMOs and ensures research complies with national and international laws.

A Day in the Life

Biosafety and Regulatory Affairs Managers in Sri Lanka ensure that biological research, clinical trials, and pharmaceutical products comply with national and international regulations — overseeing lab biosafety programs, regulatory submissions, and product approvals.

  • Manage institutional biosafety committee (IBC) operations and risk assessments for biological agents
  • Develop and maintain biosafety level (BSL) classification and containment protocols
  • Prepare regulatory dossiers for drug, diagnostic, or medical device registration with NMRA Sri Lanka
  • Review and approve biological work protocols for compliance with WHO biosafety guidelines
  • Train laboratory staff on biosafety procedures, PPE requirements, and emergency response
  • Liaise with NMRA, WHO, and international regulatory bodies on product approval submissions
  • Conduct internal biosafety audits and implement corrective actions
  • Monitor regulatory guideline changes and update company SOPs accordingly

Work Environment

OFFICETeam: SMALLBUSINESS CASUALRemote: MEDIUM

Typical hours: 45h/week · WLB score 7/10 · OCCASIONAL overtime

Mostly office-based; regulatory submission deadlines can require concentrated overtime periods.

Skills Required

Technical Skills

Regulatory submission (CTD/eCTD format)Biosafety risk assessmentGMP/GLP complianceNMRA Sri Lanka regulatory knowledgePolicy interpretation

Soft Skills

Regulatory communicationAttention to detailOrganisational leadershipStakeholder management

Tools & Software

eCTD publishing toolsDocument management systems (Veeva, SharePoint)Risk assessment templatesLIMSExcel

Salary in Sri Lanka (LKR / month)

Entry LevelRs.70k – Rs.110k/mo
Mid-LevelRs.140k – Rs.260k/mo
SeniorRs.260k – Rs.460k/mo
Entry: Regulatory Affairs Associate / Biosafety OfficerMid: Biosafety & Regulatory Affairs ManagerSenior: Senior Regulatory Affairs Director / Head of Biosafety

Typical progression: 5yr to mid · 10yr to senior

Regulatory Associate → Biosafety Officer → Regulatory Manager → Senior Director

Global Salary (USD / year)

Entry Level$55k – $85k/yr
Mid-Level$85k – $135k/yr
Senior$135k – $210k/yr

Top Markets

USAEUUKSingaporeIndiaUAE

Market Outlook

GROWING

Growing with pharmaceutical industry expansion, NMRA strengthening, and increased clinical trial activity in Sri Lanka.

Hiring: MEDIUM

Hemas PharmaceuticalsCIC Holdings pharmaAstron LtdNMRA Sri Lankauniversities with research programs

GROWING

High demand globally with expanding pharmaceutical pipelines, biosimilar approvals, and tightening biosafety regulations.

Entry Requirements

Sri Lanka

Min. EducationBSc Pharmacy, Life Sciences, or Biochemistry
Experience2–4 years in regulatory, quality, or laboratory role

Preferred

MSc Regulatory Affairs or Pharmaceutical SciencesRAPS certificationICH GCP/GMP training

Global

Min. EducationBSc/MSc Life Sciences, Pharmacy, or Regulatory Affairs
Experience3–5 years in regulatory or biosafety role

Preferred

RAPS RAC certificationISO 15189 auditorGMP/GLP inspector training

Helpful Certifications

BSc Life Sciences or PharmacyRegistered Biosafety Professional (RBP)RAPS Regulatory Affairs certificationICH GCP/GMP training

Entrepreneurship & Freelancing

Freelance: LOWRemote: MEDIUMCapital: LOW
0

Risks & Challenges

AI Replacement Risk

LOW

LONG TERM

Burnout Risk

LOW

Job Security (SL)

HIGH

How to Qualify in Sri Lanka

View all paths →

At a Glance

SL Salary (entry)Rs.70k – Rs.110k/mo
SL Salary (senior)Rs.260k – Rs.460k/mo
Global (senior)$135k – $210k/yr
SL DemandGROWING
WLB Score7/10
Hours/week~45h
Remote WorkMEDIUM

AI Replacement Risk

LOW

LONG TERM

Sectors

Private

Reviews & Ratings

Loading reviews…

More Science & Research Career Profiles

Microbiologistup to LKR 115k/mo
Marine Biologistup to LKR 125k/mo
Quality Control (QC) Chemistup to LKR 115k/mo
Environmental Consultantup to LKR 140k/mo
Laboratory Managerup to LKR 130k/mo
Environmental Operations Managerup to LKR 140k/mo

Frequently Asked Questions

Biosafety and Regulatory Affairs Managers in Sri Lanka ensure that biological research, clinical trials, and pharmaceutical products comply with national and international regulations — overseeing lab biosafety programs, regulatory submissions, and product approvals.

To become a Biosafety & Regulatory Affairs Manager in Sri Lanka, you typically need BSc Pharmacy, Life Sciences, or Biochemistry. Relevant degree programmes include: Biological Science, Biological Science. Explore step-by-step career roadmaps contributed by Sri Lankan Biosafety & Regulatory Affairs Managers at paths.lk/career-paths/biosafety-regulatory-affairs-manager.

In Sri Lanka, a Biosafety & Regulatory Affairs Manager earns LKR 70k–LKR 110k/month at entry level, LKR 140k–LKR 260k/month at mid-level, and LKR 260k–LKR 460k/month at senior level. Globally, experienced Biosafety & Regulatory Affairs Managers earn USD 210k+/year.

Key skills for a Biosafety & Regulatory Affairs Manager in Sri Lanka: Regulatory submission (CTD/eCTD format), Biosafety risk assessment, GMP/GLP compliance, NMRA Sri Lanka regulatory knowledge. Important soft skills: Regulatory communication, Attention to detail, Organisational leadership. Tools and software: eCTD publishing tools, Document management systems (Veeva, SharePoint), Risk assessment templates, LIMS.

Regulatory Associate → Biosafety Officer → Regulatory Manager → Senior Director

Growing with pharmaceutical industry expansion, NMRA strengthening, and increased clinical trial activity in Sri Lanka.