Business Services & Consulting • all cities, ME 22
Global Regulatory Affairs Lead (CMC and Development (22)
all cities, ME 22On-sitePosted 1 day ago
Business Services & Consulting
About the Role
Global Regulatory Affairs Lead (CMC and Development)
Looking for an experienced 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.
** REMOTE WORKING OPPORTUNITIES AVAILABLE ACROSS GERMANY, US (EAST COAST) AND UNITED KINGDOM **
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 supra-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
Global Regulatory Affairs Lead (CMC and Development)
Looking for an experienced 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.
** REMOTE WORKING OPPORTUNITIES AVAILABLE ACROSS GERMANY, US (EAST COAST) AND UNITED KINGDOM **
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 supra-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
What You'll Do
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 supra-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.
