Assistant Manager Regulatory and Medical

We are looking for an Assistant Manager Regulatory and Medical with excellent communication and technical knowledge for our Pharmaceutical Division.

Key Responsibilities

• Ensure compliance with all regulatory requirements and stay updated on local and international pharmaceutical regulations.
• Manage certifications, registrations, and approvals with DRAP (Drug Regulatory Authority of Pakistan) and other relevant authorities.
• Prepare and submit product registration dossiers, including CTD (Common Technical Document) and other necessary documentation.
• Develop and manage product data sheets, labels, and packaging materials in line with regulatory standards.
• Facilitate product enlistment and registration, ensuring timely approval and compliance with laws.
• Coordinate with quality assurance and manufacturing teams to meet regulatory standards during production.
• Engage with DRAP officers during audits, inspections, and regulatory interactions.
• Conduct medical trials.
• Research and suggest new pharmaceutical molecules, medical devices, and market trends.

• Collaborate with marketing and sales teams to provide updated scientific data, clinical studies, and product marketing points.
• Analyze studies to identify key differentiators and create competitive marketing strategies.
• Create and deliver impactful presentations and training materials for internal teams, healthcare professionals, and customers.
• Plan and conduct scientific presentations to doctors, healthcare providers, and regulatory bodies, highlighting product benefits and usage.
• Ensure all marketing materials and product claims comply with regulatory and ethical guidelines.

• Act as a liaison between the company and regulatory authorities, healthcare professionals, and stakeholders.

• Build and maintain relationships with healthcare professionals, regulators, and industry leaders.

• Monitor regulatory trends and advise senior management on potential business impacts.

• Support cross-functional teams in launching new products by ensuring timely regulatory approvals.

• Prepare, review, and maintain all regulatory submissions, approvals, and communication records.
• Develop and update Standard Operating Procedures (SOPs) to align with regulatory requirements.
• Provide regular reports on regulatory and medico-marketing activities to senior management.

• Conduct training sessions for internal teams on regulatory updates, product knowledge, and compliance requirements.
• Mentor and guide junior staff in regulatory and medico-marketing roles.

• Degree in Pharmacy (Pharm-D)

• Minimum 1  year of experience in regulatory affairs and medico-marketing within the pharmaceutical industry.

• In-depth knowledge of DRAP regulations, international regulatory frameworks, and guidelines.
• Strong expertise in CTD preparation and product dossier management.
• Excellent analytical skills for interpreting clinical studies and extracting marketing insights.

• Proficiency in creating impactful presentations and delivering them to diverse audiences.
• Exceptional communication, interpersonal, and negotiation abilities.