Sr. Manager, Regulatory Affairs
Responsible for supporting the Regulatory department across a number of company-sponsored projects. Primarily responsible for assembling and reviewing regulatory dossiers prior to review by senior regulatory management. May select, develop, and evaluate personnel to ensure the efficient operation of the function. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
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 Leads the internal teams for regulatory filings and registrations by coordinating, assembling, preparing and editing for review 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, INN, NDA, BLA, CTD, CTA, IMPD, MAA, Drug/ Device Master Files, DSUR 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 specifications, methods, SOPs, protocols, reports, labeling, and etc... for regulatory compliance. Maintain regulatory submissions and correspondence for company-sponsored projects, and all company-related sections for partner-sponsored projects. Drafts and reviews Regulatory Affairs' SOPs and work instructions Provides 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. Works with department management to drive 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. Other duties as assigned.
A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 9 years industry experience is required. A minimum of 7 years experience in the pharmaceutical or other related industry is required. Minimum of 5 years hands-on Regulatory Affairs experience, in either drugs and/or medical devices is required. Thorough understanding of major FDA, EMA, ICH guidelines and evolving regulatory landscape and knowledge of GCP and Quality requirements required. A minimum of 5 years previous management experience may be required. Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills. Must be highly organized, 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).