The Head of Regulatory Chemistry, Manufacturing, and Control (CMC) will be responsible for leading preparation of high quality regulatory submission content focusing on chemistry, manufacturing, and control to support global clinical development, registration, and product life cycle management. He/she will provide leadership, high level strategic and operational regulatory direction and mentorship on projects including, but not limited to CMC regulatory strategies, CMC regulatory requirements for clinical studies and marketing approval in domestic and international markets, CMC regulatory strategic development plans, and Health Authority interactions while ensuring that the latest requirements, standards and trends within the company and industry are met.
This individual has departmental and corporate level influence and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend CMC regulatory strategy.
Externally, the Head of Regulatory CMC will interface with outside regulatory agencies and business partners regarding CMC development, regulatory, and registration strategies. He/she will support/lead development and implementation of department policies. This individual will also maintain awareness of global regulatory environment and assess and communicate impact of changes on business and product development programs.
The Head of Regulatory CMC reports to the Head of Regulatory Affairs who, in turn, reports to the Head of Research and Development. Currently the position has one direct report to assist with technical writing on CMC matters.
BS degree in a biological science is required (e.g. immunology, virology, molecular biology); MS/PhD preferred.
Fifteen years of pharmaceutical/biotechnology industry experience including five years of leadership experience within the CMC function.
Expert understanding of molecular biology and or virology required.
Experience in viral vaccine or viral vector gene therapy manufacturing is desired.
Extensive regulatory experience including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with health authorities, leading and managing regulatory teams, developing and implementing complex regulatory CMC strategies with a proven track record of significant regulatory accomplishments.
Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions and understand impacts on regulation.
Development strategies to discuss CMC matters with health authorities to lead the development of briefing documents.
Strong interpersonal skills and the ability to collaborate effectively with various technical area experts including process development, analytical, manufacturing, quality, and supply chain.
Experience and knowledge in the preparation of electronic submissions.
Knowledge and understanding of US and ex-US regulations and ICH guidelines.
Highly computer literate (Word, Excel PowerPoint), including formatting and getting document submission-ready.
Proactively manages critical CMC issues, taking leadership for the regulatory contribution Excellent written and communication skills and attention to detail.
Domestic and international travel as required (~15%).
We will evaluate incoming resumes based upon this role’s qualifications. If we are interested in further discussing the position with you, we will be in contact. Thank you for your interest.
Internal Number: S1225
About Salveson Stetson Group, Inc.
Salveson Stetson Group is a retained executive search firm that helps organizations find senior executives who match their precise needs and culture.
The firm was founded in 1996 by John Salveson and Sally Stetson, highly respected human resources consultants. Under their leadership, the Salveson Stetson Group has handled hundreds of searches for leading organizations in a variety of industries.