Regulatory Affairs Manager & Technical Director

National Pharmaceutical company is looking for RA MANAGER & TECHNICAL DIRECTOR.

The Technical Director/Regulatory Affairs Manager for Colombia will lead, manage, and provide strategic direction to develop and execute regulatory strategies and plans for the products of the Company´s portfolio. Furthermore, as Technical Director is the sanitary responsible and representative of the company before the Health Authority INVIMA and the Health Ministry, assuring the compliance of all quality, regulatory and promotional activities of the Company with the sanitary laws in force related to synthesis, biologic and biotechnological products commercialized by the company

This role reports to the General Director.

JOB RESPONSIBILITIES

• Lead and manage the development of regulatory strategies to support the registration of new products, line extensions, major variations, and lifecycle management.
• Provide strategic contribution to the country leadership team– anticipate what regulatory needs to contribute to achieve business objectives. Communicate in an effective way the regulatory approvals, denials, requirements, or issues to define a conjunct strategy.
• Lead the company's SGC ISO 9001 V 2015, ensuring the maintenance of processes and consolidating information from the management review, ensuring the preservation of certification.
• Be the responsible before the regulatory agency for all the quality and regulatory issues to be in sanitary compliance.
• Relationship and management with 3PL
• Liaison with personnel responsible for regulatory affairs of our international strategic allies.

MINIMUN SKILLS REQUIRED

• Leadership
• Strategic Mindset
• Planning & Control
• Driven Results
• Effective Negotiation.
• Minimum of 1 to 3 years of experience in the position or similar positions is required, with knowledge of drug development, rules, regulations, and guidelines.

OTHER CONDITIONS

• Conditions of law.
• Prepaid medical assistance for the employee