Scientific Office Manager📣 Job Ad

About the Role

Biologix is seeking a Scientific Office Manager to lead and oversee all Scientific Office activities in Riyadh, Saudi Arabia. This role is responsible for ensuring strict adherence to SFDA regulations, pharmaceutical laws, company policies, and ethical standards. The Scientific Office Manager will act as the company's official scientific representative to health authorities, driving excellence across regulatory, scientific, compliance, pharmacovigilance, and promotional functions. This is a full-time position contributing to the company's scientific and regulatory integrity.

Key Responsibilities

• Lead all Scientific Office activities in accordance with SFDA regulations and licensing requirements.
• Serve as the company's official representative before the SFDA and other relevant regulatory authorities.
• Ensure comprehensive compliance with all applicable pharmaceutical laws, regulations, company policies, and industry standards.
• Maintain readiness for inspections and audits, and support regulatory assessments.
• Ensure the provision of accurate, balanced, and evidence-based scientific information on company products to all stakeholders.
• Manage scientific and medical information requests from healthcare professionals, authorities, and external stakeholders.
• Ensure all scientific communications align with approved product information and regulatory requirements.
• Develop and implement local regulatory strategies to support business objectives.
• Provide support for product registrations, renewals, variations, transfers, and all lifecycle management activities.
• Ensure timely and accurate regulatory submissions and approvals, including processing Special Import Permits (SIP) when necessary.
• Continuously monitor regulatory changes and provide guidance on their potential impact on company operations and products.
• Review and approve all promotional and non-promotional materials for compliance with SFDA regulations, approved product information, and internal procedures.
• Ensure all promotional claims are scientifically accurate, balanced, and adequately substantiated.
• Support compliance reporting and disclosure requirements in collaboration with internal departments.
• Build and maintain professional relationships with the SFDA, MOH, NUPCO, healthcare institutions, scientific associations, and academic organizations.
• Represent the company in meetings with regulatory authorities and external stakeholders.
• Coordinate responses to all regulatory inquiries and requests.
• Support the organization of scientific congresses, symposia, educational meetings, webinars, and healthcare awareness initiatives.
• Secure all necessary approvals for company-sponsored scientific activities.
• Foster scientific collaboration with healthcare professionals, scientific societies, and academic institutions.
• Contribute to research initiatives in accordance with ethical and regulatory requirements.
• Deliver scientific and regulatory training to employees.
• Support commercial, medical, and support teams by providing training on products and compliance requirements.
• Promote awareness of Scientific Office responsibilities and regulatory obligations throughout the organization.
• Serve as an internal subject matter expert on regulatory and scientific matters.

Qualifications and Requirements

• Bachelor's degree in Pharmacy.
• A minimum of 2 years of experience specifically within a Scientific Office role.
• Strong knowledge of SFDA regulations and pharmaceutical legislation.
• Proven understanding of compliance requirements within the pharmaceutical industry.
• Excellent communication skills, both written and verbal.
• Demonstrated ability in stakeholder management.
• Experience working effectively with cross-functional teams.
• Ability to liaise and collaborate effectively with regulatory authorities.
• Strong organizational skills.
• Proficiency in analytical thinking and problem-solving.
• High ethical standards and meticulous attention to detail.

Required Skills

• SFDA Regulations
• Pharmaceutical Laws
• Compliance Requirements
• Communication
• Stakeholder Management
• Cross-functional Team Collaboration
• Regulatory Authority Engagement
• Organizational Skills
• Analytical Skills
• Problem-Solving Skills
• Ethical Standards
• Attention to Detail

Work Environment and Location

This is a full-time position based in Riyadh, Saudi Arabia. The role requires active engagement with regulatory authorities and internal teams, contributing to the scientific and regulatory integrity of Biologix's operations within the pharmaceutical sector.