Manager, Regulatory Affairs (CMC)
Responsible for supporting the Regulatory department across a number of company-sponsored projects. Primarily responsible for assembling and reviewing CMC regulatory portions of dossiers prior to review by senior regulatory management. May select, develop, and evaluate personnel to ensure the efficient operation of the function.
Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems. Responsible for preparing and reviewing technically complex biological regulatory CMC submissions. Requires extensive interaction with departments within and outside of Pharmaceutical Development and Manufacturing (PDM) for preparing regulatory documents while meeting aggressive timelines. Ensures regulatory submissions are in line with regulatory requirements and company policies and procedures. Ensures filings are completed in a timely manner, and that sound scientific justification is employed in CMC regulatory strategy. Supports regulatory filings and registrations by coordinating, assembling, preparing and editing for review CMC portions of regulatory document packages in support of investigational and new device and/or drug applications, and post-approval submissions, for US and ROW (e.g., 510(K), IDE, IND, NDA, CTD, CTA, IMPD, MAA, Drug/ Device Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc.)
Prepares information for, review and ensures that submissions meet format and content requirements applicable for regulatory requirements (i.e., US, ICH). Reviews CMC requirements such as specifications, analytical methods, SOPs, protocols, reports, labeling, and etc... for regulatory compliance. Drafts and reviews Regulatory Affairs' SOPs. May participate in, and provide regulatory guidance to working teams (both internal and partnered programs). Supports other projects as needed, which will include but not be limited to performing research and compiling materials to develop regulatory strategies. Coordinates with collaborating departments to provide input on timelines for submissions. Solves problems of moderate levels of complexity following established company policies and procedures. Follows general instructions to complete projects. Organizes workday to complete mid-term assignments. Capable of working independently to complete mid-level assigned projects. May be responsible for conducting performance reviews and providing feedback and coaching to direct reports.
A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 8 years industry experience is required. A minimum of 6 years experience in the pharmaceutical or other related industry is required. Minimum of 4 years hands-on Regulatory Affairs experience, in either drugs and/or medical devices is required. A minimum of 5 years previous management experience may be required. Must have experience with thoroughly reviewing regulatory/quality CMC documentation for accuracy and conformance to regulatory/quality requirements. Knowledge of regulatory/quality CMC related requirements is a must. Biological regulatory experience a requirement. Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills. Must be detail- and goal-oriented, quality conscientious, and customer-focused. Must be able to adhere to strict project timelines. Experience in working in a multi-disciplinary team environment is preferred. Ability to adapt to changing priorities and to manage multiple tasks is required. Strong computer skills in Word, Excel and Adobe Acrobat, and working knowledge of electronic publishing/file management systems are an asset. Ability to use Internet for research applications is required. Expected to maintain current awareness of US, and knowledge of ROW regulatory requirements, guidelines and regulations (i.e., cGXP).