PPD is seeking a Principal Regulatory Affairs Specialists to join our team growing Regulatory Affairs department. This is a fantastic opportunity to further your regulatory career, and develop your expertise in this field.
In this role you will be a pivotal team member with at least 4-5 years regulatory experience. You will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision and marketing of these services.
You'll work with the Regulatory Affairs management to perform the day to day operational aspects of the department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature. You will also act as prime interface with the sponsors of assigned projects.
The following skills are required to be successful in this position:
• Experience developing regulatory strategies globally
• Experience and knowledge of bid defence meetings
• Experience leading global regulatory projects
• Client facing experience
Education and Experience Requirements:
• Ideally candidates will have a scientific degree (or equivalent)
• Knowledge and understanding of ICH and global regulatory guidelines required
The soft skills include but not limited to:
• Strong interpersonal, organizational and planning skills
• Ability to adapt quickly, and lead clinical trial projects
• Ability to confidently perform in client facing role
• Excellent verbal and written communication skills
• Excels working in a team setting
• Comfortable working autonomously