Research Associate / Senior Research Associate – Regulatory Affairs (Biologicals) | Bachwell Pharma

Biopractify; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Bachwell Pharma invites applications for Research Associate / Senior Research Associate in Regulatory Affairs (Biologicals). You will compile and manage regulatory dossiers in eCTD/CTD/ACTD formats for LATAM and ROW markets, and support submissions to health authorities.

This role requires strong regulatory experience in biologicals/biosimilars and cross-functional teamwork. Ideal candidates hold an M.Pharm or M.Tech and have 2–5 years (RA) or 5–10 years (Sr RA) of experience, with excellent

Qualifications

• M.Pharm/M.Tech or equivalent postgraduate qualification.
• 2–5 years of regulatory affairs experience for RA role; 5–10 years for Senior RA.
• Experience in regulatory affairs for biologicals/biosimilars, dossier prep and submissions.

Responsibilities

• Compile, review, format, and manage regulatory dossiers in eCTD/CTD/ACTD formats.
• Support regulatory submissions to health authorities across LATAM and ROW.
• Coordinate with R&D, QA/QC, Clinical, and other teams for timely responses.
• Monitor regulatory guidelines and perform gap analyses for regional requirements.
• Ensure documentation is complete, accurate, and regulatory-ready.

Skills

Regulatory Affairs

Biologics / Biosimilars

Dossier preparation

Regulatory submissions

eCTD / CTD / ACTD

Cross-functional collaboration

Education

M.Pharm

M.Tech

Postgraduate degree

Job description

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

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)
• 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

• Certificate of Pharmaceutical Product (CPP)
• Free Sale Certificates (FSC)
• GMP Certificates
• 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)

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.