Associate Director/Director, Regulatory Affairs CMC

About the Position

This position manages the successful operation of the department and provides regulatory expertise.

Primary responsibilities:

• Responsible for regulatory CMC strategy for product development and registration for small molecule investigational products. Conduct risk assessments and recommend development options.


• Oversees the writing, editing, reviewing and compiling CMC documents needed for regulatory submission activities for US and global assigned products. The submissions include IMPD, INDs, CTAs, NDAs, MAAs, meeting requests, briefing documents, and annual reports, and well as contribution from a CMC perspective on other submissions and clinical documents


• Participation in Health Authority interactions on CMC matters.


• Provides critical review of CMC documentation supporting regulatory submissions and communications.


• Collaborate cross-functionally with Regulatory Affairs, CMC, and Quality to ensure compliance such as manufacturing records review, release and change controls.


• Provide leadership for regulatory document management systems and maintain regulatory files.


• Ensures CMC regulatory milestones are met to support regulatory submission and overall business goals of the Company,


• Contribute to the development of the overall regulatory strategies


• Research and identify new opportunities outside of assigned work that augment Company’s mission, vision, values, and goals


• Effectively manages and mentors regulatory staff


• Oversees the external vendors and contractors with responsibility for providing regulatory support to ensure goals are achieved


• Primary liaison with regulatory agencies § Interacts with senior management to report on project or program milestones


• Provides strategic or operational input on project team


• Builds professional and effective external relationships crucial to the success of the organization


• Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders


• Fully involved and responsible for all areas of communication with FDA and other government regulatory authorities


• Other duties as assigned

Education, skills and other requirements:

• BS/BA degree in a scientific/health sciences discipline


• 7 years experience in CMC Regulatory Affairs


• Experience in the preparation of submissions, regulatory documents, annual reports, amendments and supplements


• Proven ability to strategize with team members on the optimal way of documenting various submissions and determining the preferred plan


• Management expertise on the timeline and process for submissions


• Expert knowledge of regulations and guidance’s affecting routine regulatory activities and specific therapeutic areas and keeps abreast of the regulatory environment


• In-depth knowledge of overall global drug development


• Excellent written, interpersonal and communication skills


• Action oriented and committed to meeting FDA and other regulations while moving projects forward


• Able to handle changing priorities and multidisciplinary tasks


• Easily gains trust and support of peers; encourages collaboration


• Strong project management skills

Salary: Starting salary $130,000 – $200,000 depending on experience.