Regulatory Affairs Executive

Job Summary
We are seeking a qualified and motivated professional to join our Regulatory Affairs Department. The ideal candidate will hold a Doctor of Pharmacy (Pharm-D) degree and possess 1-2 years of relevant experience in regulatory affairs within the pharmaceutical industry. This role demands a solid understanding of regulatory frameworks, product registration processes, and compliance standards. The successful candidate will play a key role in supporting regulatory submissions, licensing activities, and ensuring adherence to all applicable regulations.

Key Responsibilities
The candidate will be responsible for preparing and managing regulatory submissions, including licensing applications and renewals. They will develop and compile dossiers in Common Technical Document (CTD) and abridged CTD (aCTD) formats, strictly following regulatory guidelines. Staying current with DRAP (Drug Regulatory Authority of Pakistan) regulations and any changes in the regulatory landscape is essential.

Coordination with internal departments such as Quality Assurance, Production, and Marketing, as well as external regulatory agencies, will be critical to facilitate smooth product registration and approval processes. The role also involves maintaining comprehensive documentation related to Good Manufacturing Practices (GMP) compliance and providing support during audits when required.

Managing multiple regulatory projects simultaneously is a key aspect of this position, ensuring all submissions are accurate and submitted within deadlines. Effective communication with regulatory authorities and internal stakeholders is necessary to resolve queries promptly and provide timely updates on submission statuses.

Required Qualifications
Candidates must have a Doctor of Pharmacy (Pharm-D) degree, which is mandatory for this role. Additionally, 1-2 years of hands-on experience in regulatory affairs within the pharmaceutical industry is required. A thorough knowledge of DRAP regulations and regulatory procedures is essential.

Experience in preparing and submitting dossiers in CTD and aCTD formats is required, along with familiarity with product registration (PRV) procedures. Candidates should also have practical experience in licensing submissions and renewals. A sound understanding of Good Manufacturing Practices (GMP) compliance and the associated documentation requirements is necessary to support regulatory and audit activities effectively.

Preferred Qualifications and Benefits
Strong communication and coordination skills are highly valued, as the role requires collaboration across multiple teams and interaction with regulatory bodies. The ability to manage several regulatory submissions concurrently, demonstrating excellent organizational and time-management skills, is important.

Proficiency in preparing clear and compliant regulatory documentation and correspondence will contribute to success in this role. This is a full-time position offering a competitive monthly salary ranging from Rs50,000 to Rs70,000.

The role requires in-person attendance at the designated work location. Interested candidates are encouraged to apply before the application deadline on 23/06/2025.

This position offers an excellent opportunity for professionals looking to advance their careers in regulatory affairs within the pharmaceutical sector. The successful candidate will contribute significantly to the regulatory compliance and successful registration of pharmaceutical products, supporting the company’s growth and commitment to quality.