Director of Regulatory Affairs

HR Capital Consultant; Karachi Division; On-site; PKR 6,000,000 - 10,000,000; Full time

Job summary

HR Capital Consultants is seeking a Director Regulatory Affairs for a top ten pharmaceutical manufacturer based in Karachi, Pakistan. You will define regulatory strategies, ensure compliance with DRAP and cGMP, and manage end-to-end interactions with authorities.

The ideal candidate has 10–12 years in pharma and at least 2 years as Manager Regulatory Affairs, with strong leadership and communication skills.

Qualifications

• Education as stated: B.Pharm / Pharm-D / M.Sc. in a relevant discipline from a reputable institution.
• 10–12 years of overall pharma experience; exposure in reputable manufacturing organizations.
• At least 2 years in a Manager Regulatory Affairs role.
• In-depth knowledge of DRAP regulations and cGMP guidelines; dossier preparation.
• Strong written and verbal communication; leadership and team management abilities.

Responsibilities

• Define regulatory strategies to support product registrations and lifecycle management.
• Ensure compliance with DRAP regulations and international standards across products.
• Oversee end-to-end interactions with regulatory authorities (DRAP and others).
• Provide leadership to the Regulatory Affairs team and drive regulatory excellence.

Skills

Regulatory strategy

Leadership

Communication

Regulatory compliance

Education

B.Pharm / Pharm-D / M.Sc. in a relevant discipline

Tools

CTD/eCTD formats

Job description

Our client, one of the top ten pharmaceutical manufacturer of Pakistan is seeking a highly competent, strategic, and result-oriented Director Regulatory Affairs to oversee their Regulatory Affairs Department.

The ideal candidate will be responsible for defining regulatory strategies, ensuring strict compliance with local and international standards, and managing end-to-end interactions with regulatory authorities (DRAP).

Qualifications & Requirements

• Education: B.Pharm / Pharm-D / M.Sc. in a relevant discipline from a reputable institution.
• Experience: 10–12 years of overall experience within reputable pharmaceutical manufacturing organizations, including at least 2 years as Manager Regulatory Affairs .
• In-depth knowledge of DRAP regulations, cGMP guidelines, and dossier preparation (CTD/eCTD formats).
• Exceptional written and verbal communication skills.
• Strong leadership and team management abilities.

About Us:

HR Capital Consultants is a team of well experienced HR professionals that help employers in meeting their HR needs. We provide expert HR Consultancy covering Recruitment, Payroll, HR Software & Employee Training / Development Solutions throughout Pakistan.

About Our Client:

Our client is a well known Pharmaceutical Manufacturer based in Karachi, Pakistan. They are engaged in pharmaceutical manufacturing, marketing and exports. Their product portfolio include a wide range of Pharma Products.