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🧬 Research Associate / Senior Research Associate – Regulatory Affairs (Biologicals) | Bachwell Pharma
Company: Bachwell Pharma
📍 Location: Genome Valley, Hyderabad, Telangana, India
💼 Positions Available: 2 – Research Associate / Senior Research Associate
🔬 Department: Regulatory Affairs (Biologicals) | Dossier Preparation & Compilation | Regulatory Submissions | Query Management | Regulatory Intelligence & Compliance
Bachwell Pharma is hiring Research Associate / Senior Research Associate – Regulatory Affairs (Biologicals) professionals to support regulatory activities for LATAM and Rest of World (ROW) markets. This opportunity is ideal for candidates with experience in biologicals/biosimilars regulatory affairs, dossier preparation, submissions, regulatory intelligence, and cross-functional collaboration.
🔬 What You’ll Work On
Regulatory Dossier Preparation & Compilation
Compile, review, format, and manage regulatory dossiers in eCTD, CTD, and ACTD formats according to the requirements of health authorities across LATAM and ROW markets.
Support submissions to regulatory agencies including ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), ANMAT (Argentina) and authorities across ASEAN, MENA, CIS, South Africa/SAHPRA, and other regions.
Biological Data Synthesis
Collate and review technical information for biological products, including:
- Module 3 – Quality / CMC
- Module 4 – Non-clinical
- Module 5 – Clinical Studies
Ensure regulatory documentation is technically consistent and complete.
Comparability & Characterization
Review technical data related to quality, biological activity, structure, purity, immunogenicity, biosimilarity, and comparability with reference products.
Regulatory Submissions & Lifecycle Management
Manage end-to-end regulatory submissions for:
- New Drug Applications (NDAs)
- Product renewals
- Site registrations
- Post-approval variations
- Manufacturing and process changes
- Analytical method changes
Health Authority Queries
Coordinate with R&D, Quality, and Clinical teams to prepare scientifically sound and timely responses to deficiency letters and queries raised by regulatory authorities.
Legalization & Regulatory Documentation
Manage administrative documentation requirements, including:
- Certificate of Pharmaceutical Product (CPP)
- Free Sale Certificates (FSC)
- GMP Certificates
- Legalization
- Apostilling and attestations
Regulatory Intelligence & Compliance
Monitor and interpret evolving regulatory guidelines related to biologicals and biosimilars in target markets.
Track requirements such as WHO biosimilar guidelines, ANVISA regulations, COFEPRIS regulations, and other regional regulatory frameworks.
Regulatory Gap Analysis
Conduct regulatory gap assessments to identify differences between standard biological development packages and specific regional or country requirements before submission.
Cross-Functional Collaboration
Work closely with:
- Analytical R&D
- Formulation R&D
- Process Development
- QA/QC
- Clinical Operations
- Supply Chain
- Commercial Teams
Coordinate data collection and ensure technical and regulatory consistency across submissions.
Artwork, Labeling & Packaging Compliance
Review and approve regulatory aspects of:
- Product packaging components
- Artwork and mock-ups
- Summaries of Product Characteristics (SmPC)
- Package Inserts (PI)
- Patient Information Leaflets (PIL)
🎯 Ideal Candidates
You hold an M.Pharm, M.Tech, or any relevant postgraduate/graduation qualification.
Candidates should have 2–5 years of experience for the Research Associate role or 5–10 years of experience for the Senior Research Associate role.
Professionals with experience in Regulatory Affairs, Biologicals/Biosimilars, dossier preparation, regulatory submissions, health authority queries, and international markets are encouraged to apply.
Candidates should have strong analytical, documentation, communication, and cross-functional coordination skills.
🌟 What You’ll Gain
- Opportunity to work in Regulatory Affairs for biological products.
- Exposure to LATAM and ROW regulatory markets.
- Hands-on experience with eCTD, CTD, and ACTD dossiers.
- Experience handling regulatory submissions and health authority queries.
- Exposure to biologicals and biosimilars regulatory requirements.
- Opportunity to work with cross-functional R&D, Quality, Clinical, Supply Chain, and Commercial teams.
- Experience in regional regulatory intelligence and compliance.
- Professional exposure to international pharmaceutical regulatory frameworks.
📄 How to Apply
Interested candidates can share their updated resume with the recruitment team:
📧 Email: sreddy@bachwellpharma.com
📧 Email: hr@bachwellpharma.com
📧 Email: bachwellpharma@gmail.com
Candidates are encouraged to mention the position applied for – Research Associate / Senior Research Associate – Regulatory Affairs (Biologicals) in their application.
📌 Job Details
Company: Bachwell Pharma
Department: Regulatory Affairs – Biologicals
Positions: 2
Position: Research Associate / Senior Research Associate
Location: Genome Valley, Hyderabad, Telangana, India
Experience: 2–5 Years / 5–10 Years
Qualification: M.Pharm | M.Tech | Postgraduate / Graduate
Markets: LATAM | ROW
Regulatory Areas: Biologicals | Biosimilars | Regulatory Affairs | Dossier Preparation | Submissions | Query Management | Regulatory Intelligence
Key Skills: eCTD | CTD | ACTD | CMC | Biologicals | Biosimilars | Regulatory Submissions | Health Authority Queries | Regulatory Compliance | Dossier Management
Application Mode: Email
Category
Research Associate | Senior Research Associate | Regulatory Affairs | Biologicals | Biosimilars | Pharmaceutical Jobs | Regulatory Affairs Jobs | M.Pharm Jobs | M.Tech Jobs | Dossier Management | Regulatory Submissions | Hyderabad Jobs | Pharma Jobs | Life Science Jobs
🏷️ Tags
#BachwellPharma #RegulatoryAffairs #Biologicals #Biosimilars #RegulatoryJobs #ResearchAssociate #SeniorResearchAssociate #PharmaJobs #MPharmJobs #MTechJobs #PharmaceuticalJobs #RegulatoryAffairsJobs #DossierManagement #BiosimilarJobs #HyderabadJobs #LifeScienceJobs #PharmaCareers
🏷️ Tags
#PharmaJobs #PharmaceuticalInternship #PharmaInternship #PharmaceuticalIntelligence #MarketResearch #CompetitiveIntelligence #CommercialAnalytics #LifeScienceJobs #PharmacyJobs #PharmaCareers #LifeSciences #CareerOpportunity
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