General Position Summary/Purpose:
The Associate Director/Director of Regulatory Affairs, under the accountability of the Senior 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 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, pediatric study plans, Orphan Drug Application, Breakthrough Applications, safety reports, pre-meeting packages, and NDA post-approval submissions.
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
Lead and facilitate development of Health Authority (HA) meeting requests and briefing packages in preparation for HA meetings
Expected to help lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (eg, eCTD Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports).
Lead and facilitate development of US pediatric regulatory strategy (eg, PPSR) to support approval of a pediatric written request in alignment with the global pediatric regulatory strategy
Oversee development of dossier filing plan and associated timelines with regulatory operations lead
Provide oversight to filing and study teams regarding regulations/guidelines and company SOPs to ensure successful and high quality regulatory applications
Lead and facilitate team preparation for FDA meetings
Lead and facilitate USPI labeling activities with cross functional team for planned regulatory filings
Supervisory responsibility of RA (Sr) Managers and/or RA Associates
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 manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of business development and pharmaceutical partnering are absolutely necessary.
Proven ability to communicate with executive management, external thought-leaders and operational staff.
Ability to guide, train, and supervise personnel; oversees the work of direct reports to ensure on-time, on-target and within-budget results
Flexible attitude with respect to work assignments, and new learning.
5-7+ years relevant regulatory or clinical development pharmaceutical/biotechnology experience, and extensive knowledge of all aspects of the drug development process
Prior experience leading NDA/sNDA and/or BLA/sBLA filings; prior experience with MAAs a plus
Prior work experience in hematology/oncology highly desirable
Education Requirements (degree, certifications, etc.):
BS, advanced degree in life sciences preferred (PhD, PharmD, MD, Masters in sciences)
RAC certification or Masters in regulatory sciences a plus
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