Global Regulatory Affairs CMC Lead

** REMOTE WORKING OPPORTUNITIES AVAILABLE ACROSS GERMANY, US (EAST COAST) AND UNITED KINGDOM **

Looking for an experience individual in Global CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs to join a dynamic team. This pivotal role will be responsible for leading regulatory strategy and submissions for innovative biopharmaceutical products. The successful candidate will work closely with cross-functional teams to ensure compliance with global regulatory requirements while facilitating the timely development and approval of our cutting-edge therapies.

Main Responsibilities

• Acting as Global Regulatory CMC Lead to define and execute the CMC regulatory strategy from clinical development up to market authorisation.
• Plan, prepare, and conduct interactions with national authorises and sovra-national agencies in the field of CMC.
• Establish, modify, and continuously optimize regulatory CMC processes and interfaces (internal and external)
• Supervision of vendors in the regulatory affairs department and preparation of regulatory CMC dossiers.
• Monitor changes in regulations and guidelines affecting CMC submissions; proactively communicate implications to relevant teams.
• Collaborate with internal stakeholders such as R&D, Quality Assurance, and Manufacturing to provide regulatory guidance throughout the product lifecycle.
• Monitor and adhere to changes in the regulatory CMC landscape for products in order to determine how changing regulations may impact projects/ products.

Profile

• Scientific degree or any related discipline.
• Strong professional working experience in global CMC regulatory strategy leading activities.
• Knowledge of the interdisciplinary functions involved in CMC drug development and the application of clinical research to drug development.
• Combination of strategic and operational skills.

Benefits

• Competitive salary, including attractive packages
• Remote working opportunity
• Excellent company culture
• Exposure to a dynamic and evolving Biotech company
• Professional and personal progression