Company Description Uni-Pex Pharmaceuticals Pvt. Ltd. is a WHO-GMP certified generic pharmaceutical manufacturer, within India’s key pharmaceutical manufacturing hub. Established in 1999, the company supplies quality-assured medicines that meet international regulatory standards to distributors, importers, and healthcare providers worldwide.

Its portfolio includes 190+ formulations across multiple therapeutic categories, covering tablets, capsules, oral solutions, and nutraceuticals produced under WHO-GMP and ISO 9001:2015 quality systems. With over 25 years of manufacturing and export experience, Uni-Pex maintains an established export network across Africa, Latin America, and Asia/CIS, offering country-specific dossier and product registration support. The organization focuses on consistent quality, reliable supply, and building long-term partnerships while actively expanding into regulated and semi‑regulated markets.

Role Description The QC Regulatory Affairs Specialist is a full-time, on-site role based in Panchkula. This position is responsible for coordinating quality control activities and ensuring that products, documentation, and processes comply with national and international regulatory requirements. Day-to-day tasks include reviewing and maintaining regulatory dossiers, supporting product registrations, and ensuring ongoing compliance with WHO-GMP and other relevant quality standards.

The specialist collaborates with quality assurance, production,



and documentation teams to address regulatory queries, prepare responses to authorities, and manage change controls. The role also involves monitoring regulatory updates, conducting internal audits related to regulatory compliance, and supporting continuous improvement of quality and regulatory systems.

Qualifications

- Candidates should possess strong skills in Quality Control and Quality Assurance to support compliant manufacturing and testing activities.
- Candidates should possess skills in Quality Management and Quality Auditing to oversee systems, conduct reviews, and drive continuous improvement.
- Candidates should possess knowledge of Positive Manufacturing Practice (GMP) to ensure adherence to WHO-GMP and relevant regulatory guidelines.
- Experience in regulatory affairs for pharmaceuticals, including dossier preparation, product registration, and responding to regulatory agencies, is highly beneficial.
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or a related life science field is preferred.
- Familiarity with ISO 9001 or similar quality standards, and experience in generic pharmaceutical manufacturing environments, is an advantage.
- Strong analytical, documentation, and organizational skills, with the ability to work accurately under timelines and collaborate across functions.
- Effective written and verbal communication skills in English; proficiency in additional languages used in export markets is a plus.

📌 QC Regulatory Affairs Specialist (Panchkula)
🏢 UNI-PEX PHARMACEUTICALS
📍 Panchkula