BioMatrix Hiring IRA Regulatory Affairs

B.Pharm/M.Pharm IRA Regulatory Affairs Roles at BioMatrix Ahmedabad

BioMatrix hiring B.Pharm/M.Pharm/M.Sc professionals for IRA Regulatory Affairs (Officer–Executive). 2–8 yrs experience. Ahmedabad location.

BioMatrix Healthcare is expanding its Regulatory Affairs (IRA) team to support ongoing global submissions across EU, LATAM, GCC, and Southeast Asian markets. This opportunity is ideal for candidates with 2–8 years of experience in regulatory documentation, dossier preparation, and lifecycle management for oral solids, liquids, and dry syrup formulations. With strong EU-GMP, Health Canada, and WHO-GMP credentials, BioMatrix offers a technically rich environment for professionals aiming to grow within international regulatory affairs.

Company Overview

BioMatrix Healthcare Pvt. Ltd. is a reputed pharmaceutical manufacturer and exporter with advanced R&D capabilities and multiple global approvals. The company specializes in oral solid dosage forms, liquid formulations, and dry syrups, serving regulated and semi-regulated markets. Its EU-GMP and Health Canada certified infrastructure reflects strong compliance, robust documentation systems, and a commitment to quality.

Working with BioMatrix offers exposure to:

• Global regulatory submissions (EU, LATAM, GCC, SEA)
• Innovative R&D-driven product development
• Dossier preparation for regulated markets
• End-to-end lifecycle management and post-approval maintenance

Job Role & Responsibilities

Position: Officer to Executive — Regulatory Affairs (IRA)

Key responsibilities:

• Prepare, compile, and review regulatory dossiers (CTD/eCTD/ACTD) for global market submissions.
• Coordinate with R&D, QA, QC, Production, and Packaging teams for technical documentation.
• Support product registrations, renewals, and variations across EU, LATAM, GCC, SEA regions.
• Review artwork, labeling, and packaging components to ensure regulatory accuracy.
• Maintain updated regulatory trackers, submission logs, and commitment timelines.
• Handle responses to queries from regulatory agencies and customers.
• Ensure compliance with regulatory guidelines, data integrity principles, and internal SOPs.
• Monitor regulatory changes and apply updates to existing dossiers.

This role demands technical clarity, meticulous documentation discipline, and understanding of global regulatory frameworks.

Eligibility / Qualifications

• Required Education: B.Pharm, M.Pharm, M.Sc.
• Experience: 2–8 years in Regulatory Affairs (formulations preferred).
• Technical Knowledge: Exposure to CTD/eCTD format, stability data, QOS summaries, artwork review, and global regulatory guidelines.
• Preferred Attributes: Strong writing skills, cross‑functional coordination, analytical understanding of formulation data.

Relevant Courses (comma-separated): B.Pharm, M.Pharm Regulatory Affairs, M.Sc Pharmaceutical Sciences, PG Diploma in Regulatory Affairs, Diploma in Quality Assurance, M.Sc Biotechnology, M.Sc Chemistry

Location & Salary

• Location: Corporate Office — 502-B, Times Square Grand, Sindhu Bhavan Road, Thaltej, Ahmedabad-380059.
• Salary: Not disclosed in HR brief; compensation aligned with experience and market standards.
• Work Model: On-site at corporate office.

Application Process

Interested candidates can share their updated CV to:

• Email: hr@biomatrixhealthcare.com
• Email: hrl@biomatrixhealthcare.com
• Contact Numbers: 63574 10551, 63589 70525, 97259 01031, 92288 93058
• Website: www.biomatrixhealthcare.com

Email subject suggestion: Application for IRA Regulatory Affairs — BioMatrix — [Your Name]

Why this role matters (EEAT Alignment)

Regulatory Affairs ensures that pharmaceutical products meet global safety, efficacy, and compliance standards. Working with an EU‑GMP and Health Canada approved manufacturer strengthens your expertise in high-level dossier preparation and regulatory communication. The impact is direct — accurate regulatory submissions help products reach patients safely and efficiently. This builds professional authority, enhances organizational trustworthiness, and aligns closely with EEAT principles.

High-Value Keywords Included Naturally

regulatory affairs jobs, CTD dossier preparation, eCTD submissions, global regulatory submissions, pharma regulatory roles in Ahmedabad, IRA department, regulatory lifecycle management, EU-GMP pharmaceutical jobs.

FAQs

Q: What experience range is required?
A: 2–8 years in Regulatory Affairs.

Q: Which markets will the role support?
A: EU, LATAM, GCC, SEA and other regulated/semi‑regulated regions.

Q: Which formulations will be handled?
A: Oral solids, liquids, dry syrups.

Q: Is on-site work required?
A: Yes, at the Ahmedabad corporate office.

Q: Are freshers eligible?
A: No. The minimum requirement is 2 years of RA experience.

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Category	Details
Company	BioMatrix Healthcare Pvt. Ltd.
Vacancies	Regulatory Affairs (Officer–Executive) — IRA Dept
Required Education	B.Pharm, M.Pharm, M.Sc, PG Diploma in RA
Experience	2–8 years