Regulatory Manager (CMC, EU & Japan/China)

Role Overview: As the Regulatory Manager (CMC, EU & Japan/China) at Syneos Health, you will play a crucial role in a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. The focus of the organization is on translating clinical, medical affairs, and commercial insights into tangible outcomes that address the realities of the modern market. In this role, you will have the opportunity to engage with the vast experience of Syneos Health, contributing to the collaboration on a significant percentage of Novel FDA Approved Drugs and EMA Authorized Products. Key Responsibilities: - Collaborate with a team of enthusiastic problem solvers to assist clients in achieving their objectives - Prioritize placing the customer and the patient at the center of all activities in the Clinical Development model - Challenge the status quo, take initiative, and adapt to the highly competitive and dynamic environment - Strive to expedite the delivery of therapies to make a positive impact on people's lives - Foster a diverse and inclusive workplace that values different perspectives, backgrounds, and cultures - Engage in Functional Service Provider partnerships or operate in a Full-Service setting to streamline processes and enhance client interactions Qualifications Required: - Equivalent experience in regulatory affairs, specifically in CMC, EU, Japan, or China markets - Strong understanding of regulatory requirements and processes in the biopharmaceutical industry - Excellent communication and collaboration skills to work effectively with internal teams and clients - Ability to navigate a fast-paced and evolving work environment, demonstrating agility and adaptability Please note that the tasks, duties, and responsibilities mentioned above are not exhaustive. The Company may assign additional responsibilities at its discretion. Qualifications may vary based on equivalent experience, skills, and education. The Company will determine what constitutes equivalence to the qualifications mentioned. This job description does not create an employment contract and is intended to comply with all relevant legislation, including the EU Equality Directive and the Americans with Disabilities Act. Accommodations will be provided as necessary to enable employees or applicants to perform essential job functions.,