Job Description

NNIT is one of the world’s leading consultancies for the past twenty years serving the Life Science industry around the world. We apply the latest advances in technology - such as IoT, AI, Virtual Reality, Augmented Reality, Data Analytics - to make Quality Assurance, Regulatory Affairs, Clinical, Pharma Production and Laboratory processes more effective and efficient for our clients. NNIT has grown by more than 1,000 people globally over the last four years, and we are rapidly expanding our US Operations.

We are currently seeking a Regulatory Specialist to join our team. Remote work for the next few months due to COVID. The Regulatory Specialist is a Subject Matter Expert Delivery Lead Director, able to provide oversite and input to client projects including Project Management, Expertise, Thought Leadership, and Client Lead Engagement.

The Main Responsibilities For This Person Include

• Operational Regulatory projects within Regulatory Informatics, Submissions, Intelligence, and Technology
• Set-up and maintain Regulatory Information Management systems including document management, submissions, registrations, and HA Communications
• Plan and oversight of agreements, activities and timelines
• Lead and drive cross-functional team in an international organization
• Primary contact to key clients
• Industry recognized thought leader including public speaking and publications
• IDMP Subject Matter Expertise with Processing and Data Governance
  

The Main Skills Of The Person Include

• 15+ years’ experience in Regulatory representing both business and technlogy teams
• University degree in Medicine, Pharmacy or Life Science or equivalent
• Leading Regulatory projects on time and on budget
• Good communication skills and ability to build and maintain trust with key stakeholders
• Excellent organizational skills and a hands-on approach
• Interest in mentorship
• Proficiency in English, written and spoken
  

NNIT has a unique culture and approach to business that is quickly making us an employer of choice in the US. We are open, honest and value-adding in everything we do. Whether it’s our weekly Friday meetings for all of our US employees, or our annual company-wide Kick-Off meetings, NNIT encourages employees to lean in and participate in creating new ideas and developing best practices. We want to grow our people through training and certification opportunities, as well as providing them with “stretch assignment” opportunities to gain experience in new areas. We encourage employees to work at our client sites to maximize NNIT’s value and are also open to working remotely when possible. We strive to have a good work-life balance for all of our employees.

Apply today and find out the types of career opportunities NNIT can offer you!

NNIT is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you require accommodations to apply for this or any of our roles due to a disability. please contact jqhk@nnit.com