Brookes Pharma (Private) Limited is looking for a highly experienced and motivated Senior Manager Regulatory Affairs to join our team in Karachi. This leadership role is ideal for a regulatory affairs professional with extensive experience in pharmaceutical compliance, regulatory submissions, and local as well as international regulatory frameworks.
If you are passionate about ensuring regulatory excellence and driving compliance across local and export markets, we encourage you to apply.
Job Title
Senior Manager Regulatory Affairs
Location
Karachi, Pakistan
Company
Brookes Pharma (Private) Limited
Job Overview
The Senior Manager Regulatory Affairs will lead the company’s regulatory strategy, ensuring compliance with national and international pharmaceutical regulations. The successful candidate will oversee regulatory submissions, coordinate with regulatory authorities, manage inspections and audits, and provide strategic regulatory guidance across cross-functional teams.
This position requires a strong understanding of pharmaceutical regulations, export market requirements, and regulatory documentation processes.
Key Responsibilities
- Develop and implement regulatory strategies for local and international markets.
- Prepare, review, and submit regulatory dossiers and documentation.
- Ensure compliance with all applicable pharmaceutical regulations and standards.
- Act as the primary liaison with local and international regulatory authorities.
- Monitor changes in regulatory requirements and assess their business impact.
- Lead regulatory inspections, audits, and compliance activities.
- Develop and maintain regulatory policies, procedures, and best practices.
- Provide regulatory guidance and support to cross-functional departments.
- Support product registrations and lifecycle management activities.
- Ensure timely approvals for local and export market submissions.
Required Qualifications
- Pharm-D degree from a recognized and accredited institution.
- Minimum 10 to 12 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.
- Proven experience in regulatory submissions for both local and export markets.
- Strong understanding of international pharmaceutical regulatory requirements.
- Demonstrated expertise in regulatory compliance and quality standards.
- Experience working with regulatory authorities and managing inspections.
- Excellent leadership, communication, and stakeholder management skills.
- Strong analytical and problem-solving abilities.
Preferred Skills
- Pharmaceutical Regulatory Affairs
- Drug Registration
- Regulatory Compliance
- Regulatory Documentation
- CTD & eCTD Submissions
- Export Regulatory Requirements
- Regulatory Strategy Development
- Pharmaceutical Quality Systems
- Regulatory Audits
- Market Authorization
- Cross-functional Leadership
- Risk Assessment
- Project Management
Why Join Brookes Pharma?
At Brookes Pharma, we are committed to innovation, quality, and improving healthcare through excellence in pharmaceutical manufacturing and compliance. We provide an environment where experienced professionals can lead impactful projects, contribute to regulatory excellence, and grow their careers within a dynamic organization.
How to Apply?
Qualified candidates who meet the above criteria are encouraged to apply.
Send your updated resume to:
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