Senior Regional Regulatory Science Coordinator

What you'll do

The major duties and responsibilities will include but are not limited to:

• Support for Global Regulatory Strategy creation and execution
• Representation, coordination and management of Regulatory Affaires and PV activities at Latin-America. 
• Knowledge of the portfolio, strategic support - translating RA portfolio strategy into executable responsibility (translated goals into tactic and executable plans)
• Maintaining high level of up-to-date knowledge in the context of global application/harmonization of Regulatory Intelligence/country specific requirements
• Monitors regulatory project activities and review global regulatory strategies and identifies gaps that may impact implementation within area of responsibility
• Risk and gap analysis, communication thereof at global level
• Building and maintaining relationships with company partners and regulatory institutions
• Supporting the Product Regulatory Teams through proactive issue management and information sharing based on the careful choice of Regional Leads and provided support for them
• Providing support in personnel development, training, coaching for the local teams

What You’ll Bring

• University education, preferably a field related to pharmacy or health sciences, management.
• Understanding the process of drug development, RA activities (registration processes, LCM, documentation requirements and PV) and introducing the drug to the market (knowledge in the field of GMP inspections and market access is an advantage).
•  
• Minimum 5- 6 years of experience in EU and Global regulatory sciences in human medicines, medical devices, food supplements
• Experience in coordinating regulatory activities on international markets and cooperation with business partners, with proven examples of contribution.
• Understanding the pharmaceutical industry - awareness of trends and challenges in the pharmaceutical industry, understanding the needs of partners in the region
• Building and maintaining relationships with business partners and regulatory institutions
• Cooperation with regulatory authorities in EU and other countries.
• Coordination of activities between different teams in different countries
• Ability to lead people and drive results in a complex environment
• Ability to analyze data/information and use it to make strategic decisions
• Communication – fluent English language skills both in verbal and written
• Communication – basic Spanish language skills both in verbal and written are nice to have
• Non-hierarchical team management - cooperation and supervision of LRO,
• Independence and initiative - in making decisions and solving problems, identifying new opportunities for development of the RI and business areas (competition analysis)
• Positive attitude and excellent interpersonal skills

We offer

You can work in a team of helpful colleagues, where we value supportive collaboration and thinking together. In addition, we offer
•    Challenging, responsible professional work
•    Opportunity for continuous development
•    Long-term employment in an innovative and secure workplace
•    Training and development opportunities
•    Medical services and life insurance
•    Various sport and health opportunities
•    Extensive benefits package