BDR Group of companies has grown steadily and become a house-hold name in the pharmaceutical Industry over the last 15 years, in both domestic and international arenas. We are recognized as a niche player in manufacturing of Pharmaceutical APIs and for our renowned new age formulations. The group is complemented majorly by its two companies - BDR Pharmaceuticals International Pvt Ltd and BDR Life sciences Pvt. Ltd, each one having stamped its own supremacy in respective fields, i.e. API and formulation manufacturing, respectively.
Walk in Drive
RA – US Market – Executive / Sr. Executive
Work Location : Gotri
Position Overview
We are seeking a Regulatory Affairs Specialist with up to 8 years of experience in CMC (Chemistry, Manufacturing, and Controls) aspects of pharmaceutical products. The role involves preparation, review, and submission of dossiers in compliance with regulatory requirements across the US, EU and Brazil markets.
Key Responsibilities
1) Regulatory Submissions
• Prepare, compile and review regulatory dossiers (e.g. ANDA, NDA, variations, renewals) for US and EU markets in eCTD and non-eCTD formats.
• Support regulatory responses for the Brazil, Canada and EU markets, ensuring alignment with ANVISA, HC, TGA requirements.
2) Compliance
• Ensure compliance with applicable regulatory guidelines, such as FDA, EMA, HC, TGA and ANVISA regulations.
• Monitor regulatory changes and provide timely updates to internal stakeholders.
3) Cross-functional Collaboration
• Work closely with QA, QC, R&D, and manufacturing teams to gather necessary documentation for regulatory submissions.
• Act as a liaison with external partners, consultants, and regulatory agencies.
4) Regulatory Strategy
• Contribute to regulatory strategies to expedite product approvals and maintain compliance.
• Address regulatory queries and deficiencies raised by authorities within the specified timelines.
5) Post-approval Maintenance
• Manage post-approval activities, including labeling updates, variations, and renewals for assigned markets.
6) Documentation and Database Management
• Maintain regulatory databases and ensure accurate and up-to-date records of submissions and approvals.
RA – ROW Market – Officer / Executive
Work Location : Gotri
• Dossier Compilation: Experience in compiling dossiers for multiple countries, ensuring compliance with diverse regulatory frameworks.
• Regulatory Coordination: Ability to coordinate with cross-functional teams (R&D, QA, QC, Production) to gather required data and documents.
• Routine RA Activities: Skilled in managing and completing routine regulatory affairs tasks such as submissions, renewals, and variations.
• Query Resolution: Hands-on experience in addressing and resolving regulatory authority queries effectively.
• Documentation & Compliance: Strong knowledge of international guidelines and ability to maintain accurate, audit-ready documentation.
ADL – Query and Characterization
Work Location : Baska
To perform advanced analytical method development and characterization for complex dosage forms (injectable, lyophilized products, depots, peptides, and oral solids) and to effectively handle regulatory queries from global markets in compliance with international guidelines.
Responsibilities
• Perform method development, optimization and troubleshooting.
• Includes lyophilized formulations, depot formulations, peptides and QbD.
• Conduct advanced characterization using:
o DSC (Differential Scanning Calorimetry)
o XRD (X-ray Diffraction)
o NMR (Nuclear Magnetic Resonance)
o IR (Fourier Transform Infrared)
o HPLC (High-Performance Liquid Chromatography)
o LC-MS (Liquid Chromatography-Mass Spectroscopy)
ADL – Documentation Review
Work Location : Baska
• Responsible for preparation and reviewing of Specification, Method of Analysis for raw material, in-process, finished product and other documents.
• Responsible for preparing & reviewing vendor qualification & Tech Transfer documents.
• Responsible for maintaining analytical documents & records.
• Responsible for preparing all data/documents, including microbiological, chemical, residual solvent and guaiac... documents.
• Daily and monthly calibration of instruments.
• Responsible for maintaining analytical chemicals, solvents, analytical standards and chromatographic columns within the laboratory.
ADL – MS & T
Work Location : Baska
1) Technology Transfer
• Lead or support transfer of analytical methods from R&D/ADL to QC labs or manufacturing sites.
• Prepare and review Tech Transfer Protocols (TTP) and reports.
• Coordinate with cross-functional teams (R&D, QA, QC, Production).
2) Analytical Method Support
• Perform method validation, verification and troubleshooting.
• Ensure methods comply with regulatory standards such as ICH guidelines.
• Handle instruments like HPLC, GC, NMR, etc.
3) Documentation & Compliance
• Write SOPs, protocols, reports and risk assessments.
• Ensure compliance with cGMP and regulatory requirements.
• Support audits and inspections.
Walk in Interview
Date : 27/09/2026, Sunday
Venue : 201-203 Lotus Plaza, Nr. Vishanti Heritage
Bungalow, 30 MT Road, Gotri, Vadodara-390021, Gujarat.
