Position Summary
Ensures that all imported and distributed scientific, laboratory, and diagnostic products comply with national and international regulatory standards. Maintaining the company’s commitment to quality, safety, and legal compliance across all operations.
Key Responsibilities
Regulatory Strategy: Development: Formulate and implement regulatory strategies to ensure compliance with applicable laws, regulations, and standards, particularly those set by DRAP (Drug Regulatory Authority of Pakistan)
Regulatory Submissions and Compliance: Prepare, review, and submit regulatory documents, including product registrations, pre-market notifications, and post-market surveillance reports. Ensure that all submissions are accurate, complete, and comply with regulatory guidelines.
Liaison with Regulatory Authorities: Contact with regulatory agencies. Manage communications, respond to inquiries, and facilitate inspections and audits.
Cross-Functional Collaboration: Work closely with departments such as Quality Assurance, Import, Sales, and Technical Support to ensure that regulatory requirements are integrated into all aspects of product development and distribution.
Documentation and Record-Keeping: Maintain comprehensive records of regulatory submissions, approvals, and correspondence. Ensure that all documentation is up-to-date and readily accessible for audits and inspections.
Regulatory Intelligence and Advocacy: Monitor changes in regulations, guidelines, and industry standards. Assess the impact of these changes on company operations and advise management accordingly.
Training and Education: Develop and deliver training programs for staff to promote awareness and understanding of regulatory requirements and best practices.
Qualifications
Education:
Mphil Microbiology
Experience:
5 years of experience in regulatory affairs within the pharmaceutical & medical device.
Skills:
- In-depth knowledge of local and international regulatory requirements.
- Strong analytical and problem-solving abilities.
- Excellent written and verbal communication skills.
- Proficiency in regulatory databases and software applications.
- Ability to manage multiple projects and meet tight deadlines.
Key Competencies:
- Attention to Detail: Ensure accuracy and completeness in all regulatory documents and submissions.
- Strategic Thinking: Anticipate regulatory challenges and develop proactive solutions.
- Collaboration: Foster strong working relationships with internal teams and external regulatory bodies.
- Adaptability: Stay abreast of evolving regulatory landscapes and adjust strategies accordingly.