Senior Regulatory Affairs Specialist

Company Description Uni-pex pharmaceuticals s is a research-based pharmaceutical company established in 1991 in Delhi, India, with commercial production starting in 2007. The organization is focused on extensively manufacturing high-quality pharmaceutical products aimed at enhancing the quality of human life. Uni-Pex combines strong research capabilities with proven commercial expertise to deliver reliable therapies to the market. The company holds ISO 9001:2000 certification and complies with WHO-cGMP standards, reflecting its commitment to quality and global regulatory norms.
Role Description The Senior Regulatory Affairs Specialist is a full-time, on-site role based in Panchkula. This position is responsible for preparing, reviewing, and maintaining regulatory documentation for domestic and international submissions, ensuring accuracy and alignment with applicable guidelines. The specialist will monitor and interpret regulatory requirements, advise internal teams on compliance implications, and support product development and lifecycle management from a regulatory perspective. Day-to-day activities include coordinating regulatory submissions, responding to regulatory queries, updating internal regulatory databases, and collaborating with quality, manufacturing, and R&D teams to drive timely approvals. The role also involves supporting audits and inspections, contributing to the development of regulatory strategies, and training colleagues on relevant regulatory practices and updates.
Qualifications
Strong proficiency in Regulatory Affairs and understanding of Regulatory Requirements, with the ability to interpret and apply relevant laws, guidelines, and standards.
Experience in preparing and managing Regulatory Documentation, including dossiers, technical files, and supporting records.
Demonstrated capability in handling Regulatory Submissions and coordinating with health authorities and other regulatory bodies.
In-depth knowledge of Regulatory Compliance principles, particularly within pharmaceutical manufacturing and quality systems.
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or a related field.
Several years of progressive experience in regulatory affairs within the pharmaceutical industry, ideally in a senior or lead capacity.
Familiarity with WHO-cGMP and ISO quality standards and their practical implementation in manufacturing and documentation.
Strong analytical, problem-solving, and attention-to-detail skills, with the ability to manage multiple projects and deadlines.
Effective written and verbal communication skills, and ability to collaborate with cross-functional teams on-site.
Proficiency in using standard office and documentation software for regulatory tracking, reporting, and communication.

Work arrangement
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