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The ideal candidate for this leadership role will have a strong understanding of the CMC regulatory requirements across regions, phases of development and indications for biologic, synthetic, and/or biosimilar products. This role will also require coordination of resources and tasks across the company sites.
*You will collaborate with other leadership to ensure alignment across the teams.
*You will lead process improvements, documenting CMC processes and ensuring appropriate consultation with all stakeholders.
*You will provide expertise and guidance to interdepartmental and cross-functional teams.
*You will supervise assigned team members with respect to management, training, resource planning and recruitment across the Global and Regional CMC organizations.
*You will support CMC filings including Investigational New Drug (IND)/Clinical Trial Applications (CTAs), Marketing Application/Authorization, post-approval supplement/variations, renewals and responses to agency request for Information across all regions.
*Degree educated with strong experience within regulatory or compliance environment
*CMC specific regulatory knowledge and an understanding of manufacturing, process development, quality control, or quality assurance related to biologics, small molecules, biosimilars, and/or combination products
*Preparation of global CMC submissions across all phases of development
*In-depth knowledge of global CMC requirements, including country specific documents for regional submissions
*Experience managing and leading regulatory strategies for submissions including but not limited to IND/CTAs, Marketing Application/Authorization, Annual Reports, post approval supplements/variations, etc.
*Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
*Ability to work in a fast-paced environment while retaining a high attention to detail and quality
*Strong oral and written communication skills
*Strong interpersonal, collaborative, problem solving and conflict resolution skills
*Ability to develop solutions to technical and organizational issues to improve performance and productivity
*Degree in life sciences, biochemistry, or chemistry
*Experience in leading Global regulatory CMC submissions and an understanding of global requirements and ICH guidance
*Experience with manufacturing, process development, quality control, or quality assurance
*Experience with training and/or managing staff