Regulatory Affairs & Import Specialist – Pharmacist

MedX Biotech Pvt Ltd is looking for a qualified Pharmacist with solid experience in DRAP (Drug Regulatory Authority of Pakistan) regulations and pharmaceutical product importation. The successful candidate will play a crucial role in ensuring regulatory compliance for imported pharmaceutical products, managing registration and licensing processes, and coordinating with DRAP and other regulatory authorities to facilitate the smooth entry of products into the Pakistani market. This full-time position reports to the Regulatory Affairs Manager or Director of Operations and requires hands-on involvement in regulatory affairs and supply chain coordination.

Key Responsibilities

Regulatory Compliance:
- Ensure all imported pharmaceutical products comply with DRAP rules, regulations, and licensing requirements.
- Prepare, review, and submit registration dossiers, import licenses, and product approvals to DRAP.
- Stay informed about updates to DRAP policies, SROs, guidelines, and pharmaceutical import/export regulations.
- Liaise with DRAP officials, Ministry of Health, and other regulatory bodies for approvals, renewals, and compliance issues.

Import Management:
- Oversee the entire import process for pharmaceutical raw materials, finished products, and medical devices.
- Prepare and manage import documentation such as Bill of Lading, Certificate of Analysis, Certificate of Pharmaceutical Product (CPP), Free Sale Certificate, and other customs and regulatory paperwork.
- Coordinate with customs authorities, clearing agents, and freight forwarders to ensure timely shipment clearance.
- Verify that imported products meet quality, labeling, and packaging standards as per DRAP requirements.

Product & Documentation Expertise:
- Maintain accurate records of registered products, their specifications, and regulatory status.
- Prepare technical and regulatory documentation for new product registrations and renewals.
- Collaborate with international suppliers and manufacturers to obtain necessary regulatory documents.
- Ensure proper filing and record-keeping of licenses, registrations, and correspondence with regulatory agencies.

Cross-Functional Coordination:
- Work closely with Quality Assurance, Supply Chain, and Sales teams to align regulatory timelines with business objectives.
- Support internal audits and inspections related to regulatory and import compliance.
- Provide regulatory guidance to internal stakeholders regarding new product launches and market entry strategies.

Required Qualifications
- Pharm-D or B.Pharm degree from a recognized institution (Pharm-D preferred).
- Valid Pharmacist license/registration with the Pharmacy Council.
- Minimum of 1 year experience in regulatory affairs, DRAP registration, or pharmaceutical import operations.
- In-depth knowledge of DRAP rules, Drug Act 1976, and relevant SROs/notifications.
- Practical experience with import documentation, customs clearance, and international pharmaceutical trade compliance.
- Strong understanding of pharmaceutical product specifications, quality standards, and labeling requirements.
- Excellent communication and coordination skills for effective liaison with regulatory bodies and international suppliers.
- Proficiency in MS Office and regulatory documentation software/tools.
- Strong attention to detail and ability to manage multiple registration and import timelines simultaneously.

Preferred Qualifications and Benefits
- Prior experience working directly with DRAP or in a regulatory affairs role within the pharmaceutical industry.
- Familiarity with international pharmaceutical trade regulations such as FDA, EMA, WHO-GMP is an advantage.

MedX Biotech offers a competitive salary ranging from Rs. 80,000 to Rs. 100,000 per month, depending on experience. The company provides professional growth opportunities in regulatory affairs within a collaborative work environment that includes exposure to international pharmaceutical trade. Additional benefits include health coverage and other company perks. This role requires in-person attendance at the designated work location.