Senior Manager – Regulatory Affairs

Lusynco; Karachi Division; On-site; PKR 1,800,000 - 2,600,000; Full time

Job summary

Brookes Pharma is seeking an experienced Senior Manager – Regulatory Affairs to lead regulatory strategies for local and international markets. You will oversee dossier preparation, submissions, and ongoing compliance, coordinating with cross-functional teams to navigate evolving regulatory requirements.

The role requires a Pharm-D and 10–12 years of regulatory experience in pharma, with strong leadership, audit/inspection expertise, and a track record of successful regulatory outcomes across

Qualifications

• Pharm-D with regulatory expertise required.
• 10–12 years in regulatory affairs in pharma.
• Experience developing regulatory strategies for local and export markets.
• Hands-on dossier preparation for local and international authorities.
• Knowledge of global regulatory standards and compliance.
• Experience with audits, inspections and compliance management.
• Strong leadership and cross-functional guidance能力.

Skills

Regulatory leadership

Regulatory strategy

Cross-functional leadership

Stakeholder management

Audits & inspections

Education

Pharm-D

Job description

Brookes Pharma is seeking an experienced and dynamic Senior Manager – Regulatory Affairs to lead regulatory strategies and ensure compliance with local and international regulatory requirements.

Qualifications & Experience

• Education: Pharm-D from a recognized institution
• Experience: 10–12 years of relevant regulatory affairs experience in the pharmaceutical industry
• Strategy & Compliance: Expertise in developing and implementing regulatory strategies for local and export markets
• Dossier Preparation: Hands‑on experience preparing and submitting regulatory dossiers to local and international authorities
• Global Standards: Strong knowledge of global regulatory requirements and market‑specific compliance
• Audits & Inspections: Proven experience in regulatory inspections, audits, and compliance management
• Leadership & Skills: Ability to provide guidance to cross‑functional teams, monitor evolving requirements, and demonstrate excellent communication and stakeholder management skills