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Regulatory Affairs Manager

Company: Collabera
Location: Sunnyvale
Posted on: May 5, 2021

Job Description:

Regulatory Affairs ManagerResponsibilities:Job Description: Manager, Regulatory AffairsGeneral Position Summary/Purpose:--- The Manager, under the accountability of the Director, Regulatory Affairs, helps lead teams by providing regulatory strategy and support to global development. --- He/she is expected to help support teams and efforts around major filing activities and Health Authority (HA) interaction and meetings, attend and provide regulatory support to other departments, project teams and committees. --- Organize/manage submissions to health authorities, including IND/CTAs, IND/CTA amendments, NDAs/MAAs, Orphan Drug Application, Breakthrough Applications, safety reports, pre-meeting packages, and NDA post-approval submissions. --- This position may have direct interaction with FDA representatives.Key Accountabilities/Core Job Responsibilities:--- Represents RA at project team meetings and manages/oversees regulatory workflow between departments as well as CROs as required at the study team level for management of CTAs, IMPDs.--- Serve as primary regulatory contact for CROs and lead regulatory team in development of CTA timelines, responses to HA queries and general oversight to CRO regulatory team.--- Lead and facilitate US filing activities IND/NDA submissions including but not limited to orphan drug designation, preparation and submission of meeting requests/briefing books and response to information requests--- Provide strategic input on regulatory filing documents (e.g., eCTD Module 1 label, Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports).--- Oversee development of dossier filing plan and associated timelines with regulatory operations lead--- Provide oversight to filing and study teams regarding overall regulatory strategy to ensure compliance with global HA regulations/guidelines and company SOPs to ensure successful and high quality regulatory applications--- Direct interaction with FDA as point of contact for IND/NDA. Build and maintain excellent relationships with FDA personnel--- Lead the development and authoring of internal procedures and company SOPs ensuring compliance with existing regulations and guidelines.--- Execute, independently or with very limited guidance and supervision, product development and regulatory strategies regarding submissions and/or compliance issues--- Additional Functions:o Foster cross-functional teamwork and improve intra-/inter-departmental communications--- Collaborate with external parties, i.e., partner companies and investigator-sponsors, on regulatory strategy for IND and NDA filings--- Supervise regulatory staff and mentor/train RA associates in carrying out responsibilities. Coordinate RA associates' activities and career development--- Position will regularly interact with all departments and all levels within a department--- Position may have direct reportsQualifications:--- Specialized knowledge of regulatory activities including but not limited to submissions to HAs, including NDA/BLA/MAA, INDs/CTAs, IND/CTA amendments, safety reports, pre-meeting packages, and post-approval submissions--- Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy--- Ability to work either independently with minimal direction separately and within project teams, committees, etc. to attain group goals--- Ability to creatively complete activities within the allotted, sometimes aggressive, time schedules--- Thorough working knowledge and understanding (application of knowledge/experience) of FDA/EMA guidance and regulations, especially for drug therapeutics--- Ability to learn and assimilate scientific information--- Flexible attitude with respect to work assignments, and willingness to learnExperience:--- Minimum of five years pharmaceutical/biotechnology industry experience, with relevant U.S. regulatory experience including hands-on knowledge of all aspects of the drug development process.--- Strong scientific background and experience in critical review and interpretation of scientific/clinical data.--- Experience/competence in writing regulatory documents (e.g., meeting requests/briefing book activities).--- Prior work experience in hematology/oncology is highly desirable.--- Ability to interpret FDA/EMA regulations, guidelines, policy statements, etc., and apply to the specific situation at hand.--- Strong interpersonal skills and the ability to deal effectively with a variety of personnel cross-functionally.--- Ability to guide, train, supervise, and mentor personnel within the regulatory affairs department.Regulatory Affairs,FDA ,pharmaceutical,submissions

Keywords: Collabera, Sunnyvale , Regulatory Affairs Manager, Executive , Sunnyvale, California

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