*Hi* *Please lookup the below position and if you feel comfortable ,then please send me your updated resume *
Role : Regulatory Operations Manager Location : San Diego, CA Start : 5-8-17 Interview : Phone, Skype/In person *General Summary:* The Regulatory Operations Manager is the technical leader for electronic submissions who supports the Company across multiple functions with a focus on the systems specific to regulatory submissions and reporting. The Regulatory Operations Manager will provide technical strategies that maximize the effectiveness of the systems to ensure efficiency and accuracy of regulatory submissions. A successful candidate is expected to work closely with regulatory affairs colleagues, contract electronic publishing service providers, members of the research, development, manufacturing, quality assurance, non-clinical and clinical functional areas, and to represent Regulatory perspectives in discussions regarding regulatory operations. Specifically, the candidate will provide ongoing formatting, templates, organizational advice and guidance for optimal submissions, and ensure quality control and timely preparation of submissions. A key expectation of the candidate is that he/she maintains current knowledge of regulations and FDA and European guidance documents with respect to electronic submissions, and provides expert advice to project teams and the department. *Major Responsibilities:* • Supervises and/or participates in the gathering of information and the assembly of regulatory submissions for Company’s development- and commercial-stage products • Oversees the preparation and completion of regulatory submissions, including INDs, CTAs, NDAs, BLAs, safety reports, annual reports and routine amendments in eCTD format • Ensures that all aspects of electronic submissions and documents meet regulatory agency and Company’s submission standards and technical requirements • Establishes and maintains effective working relationship with electronic submissions vendors • Interacts with regulatory authorities for Regulatory Operations inquiries; assists in establishing departmental standards to ensure the highest quality of submitted information • Provides publishing project plans and timelines for major regulatory publishing projects • Provides technical leadership regarding the life cycle management of electronic submissions • Adheres to Company’s policies and supports management decisions and goals • Stays abreast of new technology • Assists with the training of submission activities to all levels of Regulatory operations staff • Ability to QC documents for electronic submission. *Knowledge, Skills and Abilities Required: * • A minimum of six years of *direct experience in a Regulatory Operations function with experience with electronic submissions and systems. *• Demonstrated technical leadership in the successful submissions to regulatory agencies of: *INDs in e-CTD format, IMPDs, CTAs, NDA, MAAs, BLA/Supplements, Periodic Safety Update Reports, etc. *• Demonstrated track-record in managing regulatory timelines and coordination of publishing calendar associated with the assigned submission, including initial quality control of submissions. • Relevant *working experience (with respect to Regulatory Operations needs) with the FDA, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) or equivalent experience with similar regulatory authorities e.g. EMA* • Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Adobe, XML and SML authoring tools, eCTD Software, SAS file formats. • Good communication skills • Ability to multitask and manage complex projects and timelines in a matrix within a fast-paced team environment *Neeraj Singh* *TECHNICAL RECRUITER* *VSG* *Business Solutions* *Email ID: **nee...@vsgbusinesssolutions.com* <um...@vsgbusinesssolutions.com> *Gmail ID: **neeraj....@gmail.com* <um...@vsgbusinesssolutions.com> *Phone:* 302-261-3207 ext 116 -- You received this message because you are subscribed to the Google Groups "Android Discuss" group. To unsubscribe from this group and stop receiving emails from it, send an email to android-discuss+unsubscr...@googlegroups.com. To post to this group, send email to android-discuss@googlegroups.com. Visit this group at https://groups.google.com/group/android-discuss. To view this discussion on the web visit https://groups.google.com/d/msgid/android-discuss/CAAhwvZ0VmKj5NEzfxtKFCpVEGyCFpWrh%2BBneFE-aJRAJHV%3D9Aw%40mail.gmail.com. For more options, visit https://groups.google.com/d/optout.
