Regulatory Affairs Pharmacist

This role is responsible for ensuring that all company products meet the regulatory requirements set by the Drug Regulatory Authority of Pakistan (DRAP) and other relevant authorities. The successful candidate will manage the preparation, compilation, and submission of documentation needed for product registrations, renewals, and approvals, ensuring timely compliance. Collaboration with multiple departments is essential to maintain regulatory adherence throughout the product lifecycle and to support the launch of new products.

Key Responsibilities
- Prepare, compile, review, and submit regulatory dossiers for product registrations, renewals, and variations in both local and international markets.
- Stay updated on DRAP regulations and guidelines to ensure continuous compliance of products.
- Communicate effectively with DRAP and other regulatory bodies to resolve queries, provide clarifications, and facilitate inspections.
- Respond promptly to deficiency letters, regulatory inquiries, and official notices.
- Support new product launches by securing all necessary regulatory approvals.
- Coordinate with cross-functional teams including Quality Assurance, Quality Control, Production, and Marketing to collect required documentation.
- Maintain and update regulatory databases and tracking systems related to product approvals, renewals, and variations.
- Ensure that artwork and labeling comply with all regulatory standards.
- Monitor changes in regulations and communicate relevant updates to the appropriate departments.
- Participate in regulatory audits and inspections as required.

Required Qualifications
- Education: Doctor of Pharmacy (Pharm-D) degree from a recognized institution.
- Experience: 1 to 3 years of experience in Regulatory Affairs within the pharmaceutical industry. Candidates with strong internship experience may also be considered.
- Knowledge: Thorough understanding of DRAP guidelines and familiarity with CTD/eCTD dossier formats.
- Skills: Excellent documentation and communication skills, strong attention to detail, and effective problem-solving abilities. Proficiency in MS Office applications (Word, Excel, PowerPoint) is essential. Ability to work independently as well as collaboratively within a team.

Preferred Qualifications and Benefits
- Familiarity with regulatory frameworks for international markets is an advantage but not mandatory.
- This is a full-time, in-person position.
- Monthly salary ranges from Rs40,000 to Rs45,000.
- The application deadline is June 29, 2025.

Candidates who meet these qualifications and are motivated to contribute to regulatory compliance and product success in a dynamic pharmaceutical environment are encouraged to apply.