Regulatory Operations Specialist I

Job overview

Responsibilities

• Manage laboratory instrument lifecycle activities, including installation, qualification, and maintenance; oversee qualification of new instruments and software.
• Prepare and review SOPs, protocols, validation master plans, and cGMP documentation; handle nonconformances, change controls, and corrective and preventive actions.
• Support digital transformation and maintain VMP, MMP, eCMMS asset, and preventive maintenance records.
• Conduct computerized-system data integrity assessments and evaluate instrument specifications against USP/EP standards.
• Assist with regulatory-compliant system implementation; issue laboratory notebooks and coordinate SOP and work-instruction reviews.
• Support internal and external audits and provide equipment lifecycle support to ECLs.
• Manage import/export license, Dual Use NOC, and import certificate applications, availability, debiting, and reconciliation.
• Maintain regulatory knowledge, internal and client trackers, quality checks, training documentation, and client deliverables.
• Assist in onboarding, training, and mentoring junior staff; perform additional duties assigned by the manager.

Minimum qualifications

• Bachelor’s degree in pharmacy or a related science field, or an advanced degree with experience; equivalent relevant experience may be considered.
• Alternatively, relevant engineering, B.Tech, packaging, polymer, or printing qualifications and packaging experience may be considered.
• At least 4–7 years of experience in a relevant discipline, including regulatory affairs, quality assurance, analytical science, packaging, pharmaceutics, material management, or drug development and manufacturing.
• Technical proficiency with Microsoft Office and document management and/or publishing tools.
• Speaking English and/or other applicable languages.

Experience and capabilities

• The posting cites pharmaceutical product lifecycle and regulatory knowledge, with GxP and ICH-GCP understanding desirable.
• It calls for organizational, time-management, analytical, review, and customer-focus abilities.

Preferred qualifications

• A relevant pharmacy, science, or advanced degree and specified experience levels are listed as preferred alternatives in the posting.
• A packaging-related degree or credential with packaging-field experience is also listed as a preferred alternative.
• MIS or electronic data management system knowledge, including Regulatory Information Management, is preferred.
• A Regulatory Affairs diploma or certification is preferred.
• Interpersonal, problem-solving, innovation, ownership, precision, goal-orientation, leadership, and root-cause analysis capabilities are cited.