Regulatory Affairs Coordinator- Temp Position

Company Description

At TAPI, we’re not just a company—we’re a community committed to advancing health from the core. As the world’s leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we’re shaping the future of health worldwide.

Our strength lies in our people—a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives

Job Description

The opportunity

To lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirements

How You’ll Spend Your Day

• Support the life cycle management of APIs from RA perspective
• Review and approve ROS, specification and analytical control when required
• Coordinate DMF preparation and related activities for On Time Submissions for all relevant markets
• Proactively collaborates with the Regulatory Specialist team members, which support the submission or answer service requests
• Prepare a DMF specific high level gap analysis report and proactively communicate any risk to the relevant departments. Follow up on the gaps' solving during the review period
• Respond to deficiency letters and coordinate related activities
• Coordinating pre-launch activities from RA perspective
• Manages the regulatory aspects and related tasks of the assigned commercial APIs
• Evaluate change requests and address the required submission per market to support the requested change. Follow through the submission
• Maintain up to date the DMFs according to the required regulation of updating per market
• Support customers regarding Service Requests, giving relevant professional information in the shortest of time
• Continue learning of regulatory guidance, SOPs and work processes
  
  

• M.Sc./ PHD in a relevant field, e.g. chemistry/biochemistry/biology - Must
• English Proficiency: Fluent in English, both written and spoken, at a professional level- Must
• Time Management: Effective time management skills and ability to prioritize tasks
• Attention to Details: Meticulous and accurate in work execution
• Organization and Planning: Strong organizational skills and ability to meet deadlines
• Excellent Communication: Strong verbal and written skills, both internally and externally
• Leadership and Teamwork: Effective leadership skills and ability to collaborate effectively with others
• Customer-Centric Approach: Dedicated to providing high-quality service to both internal and external stakeholders
• Adaptability and Learning: Open to new ideas, self-motivated, and capable of continuous learning
• Initiative and Proactivity: Takes initiative and is proactive in seeking solutions and opportunities