Regulatory Manager

About the role

The Regulatory Manager will be based on‑site in Kazakhstan and will lead regulatory activities for MACLEODS PHARMACEUTICALS LTD. across the region. This full‑time position ensures that product registrations, renewals and variations comply with local and international requirements.

Key responsibilities

• Prepare, review and coordinate regulatory submissions and dossiers for multiple dosage forms.
• Monitor regulatory changes in Kazakhstan and align them with WHO, EMA and ICH standards.
• Support product registration, renewal and variation processes.
• Collaborate with quality, manufacturing and marketing teams to resolve regulatory queries.
• Maintain accurate regulatory documentation and assist during health‑authority inspections and audits.
• Provide regulatory guidance and help shape regulatory strategies for new and existing products.

Required profile

• Bachelor’s or master’s degree in Pharmacy, Life Sciences, Chemistry or a related discipline.
• Prior experience in a regulatory role within the pharmaceutical industry.
• Familiarity with Kazakhstan regulatory framework and international guidelines (WHO, EMA, ICH) is an advantage.
• Strong analytical ability to interpret regulations and assess data.
• Excellent written and verbal communication skills and attention to detail.

Required skills

• Regulatory Submissions
• Regulatory Affairs
• Regulatory Compliance
• Knowledge of Kazakhstan regulatory requirements
• Understanding of WHO, EMA and ICH guidelines