Senior Regional Regulatory Science Coordinator

Long Description

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 EU and Richter partners countries
• 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
• Negotiating contracts with partners and complying with their provisions
• 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

Long Description

• 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
• Analysis and co-creation of cooperation agreements.
• 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
• 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

Long Description

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