Biologix تعلن عن وظيفة مدير المكتب العلمي في الرياض

About the Role

We are looking for a Scientific Office Manager to lead and oversee all Scientific Office activities in compliance with SFDA regulations, pharmaceutical laws, company policies, and ethical standards. In this role, you will serve as the company’s official scientific representative to health authorities while ensuring excellence in regulatory, scientific, compliance, pharmacovigilance, and promotional activities.

What Will Your Responsibilities Be

Scientific Office Leadership & Compliance

• Lead all Scientific Office activities in accordance with SFDA regulations and licensing requirements.
• Act as the company’s official representative before SFDA and other regulatory authorities.
• Ensure compliance with pharmaceutical laws, regulations, company policies, and industry standards.
• Maintain inspection and audit readiness and support regulatory assessments.

Scientific Information & Medical Support

• Ensure the provision of accurate, balanced, and evidence-based scientific information on company products.
• 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.

Regulatory Affairs Support

• Develop and implement local regulatory strategies supporting business objectives.
• Support product registrations, renewals, variations, transfers, and lifecycle management activities.
• Ensure timely and accurate regulatory submissions and approvals, including Special Import Permits (SIP) when required.
• Monitor regulatory changes and provide guidance on their impact on company operations and products.

Promotional Compliance & Ethical Practices

• Review and approve promotional and non-promotional materials to ensure compliance with SFDA regulations, approved product information, and internal procedures.
• Ensure promotional claims are scientifically accurate, balanced, and adequately substantiated.
• Support compliance reporting and disclosure requirements in collaboration with relevant departments.

Stakeholder & Health Authority Management

• Build and maintain professional relationships with SFDA, MOH, NUPCO, healthcare institutions, scientific associations, and academic organizations.
• Represent the company in meetings with regulatory authorities and external stakeholders.
• Coordinate responses to regulatory inquiries and requests.

Scientific Education & External Activities

• Support scientific congresses, symposia, educational meetings, webinars, and healthcare awareness initiatives.
• Secure required 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.

Training & Organizational Support

• Deliver scientific and regulatory training to employees.
• Support the development of commercial, medical, and support teams on products and compliance requirements.
• Promote awareness of Scientific Office responsibilities and regulatory obligations across the organization.
• Serve as an internal subject matter expert on regulatory and scientific matters.

What We're Looking For

• Bachelor’s degree in Pharmacy.
• 2 years of experience as Scientific Office.
• Strong knowledge of SFDA regulations, pharmaceutical legislation, and compliance requirements.
• Excellent communication and stakeholder management skills.
• Ability to work effectively with cross-functional teams and regulatory authorities.
• Strong organizational, analytical, and problem-solving skills.
• High ethical standards and attention to detail.