What are the responsibilities and job description for the Executive Senior Director, Regulatory Affairs position at NS Pharma, Inc.?

Job Summary

Reports to the Vice President of Research and Development with the primary responsibility to develop and implement comprehensive global regulatory strategies (except Japan) in all stages of clinical development (preclinical to commercial) to ensure timely and successful interactions with global health authorities.

Essential Duties and Responsibilities

Include but not limited to the following. Other duties may be assigned.)

Preclinical and Clinical

Create the development of global regulatory strategies (except Japan).
Serves as primary liaison to FDA, HC, and EMA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities.
Establish and maintain relationships with regulatory agencies, actively participating in interactions and submissions to secure necessary approvals and licenses.
Interprets and communicates health authority correspondence effectively and quickly to senior leadership and clinical project teams.
Partners with cross functional teams to assess regulatory support needs and aligns resources to provide regulatory support.
Identifies, monitors and resolves regulatory issues and reports progress to management
Oversees planning and execution of major submissions and responses to regulatory authorities related to INDs, amendments, NDAs and supplements within company timelines and in accordance with regulations and guidelines
Provides expert guidance to help evaluate and mitigate potential risk.
Ensures that all SOP requirements are met.
Enable best practices and SOP conformance. Use experience and judgment to identify jobs that may not be consistent with best practices, company policies or FDA guidance.
Perform other tasks as necessary and / or required to ensure regulatory compliance while effectively managing business risks.
Proactively identifies regulatory issues and identifies areas that may require revised or additional documentation.
Develop and manage the Regulatory Affairs department team and budget
Manage and collaborate with consultants and CRO partners involved in preparing US and Ex-US regulatory submissions.

Commercial

Lead and prepare the Company in US regulatory affairs activities for new product approval and launch.

Responsible for the US regulatory strategic guidance and execution from pre-launch, launch and post launch (from FDA interactions, advisory committee and launch support to a variety of planning).

Lead and manage cross-functional promotional and scientific exchange review committee meetings.

Qualifications

Solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to product submission development / strategy, and advertising and promotions to assist in meeting organizational goals.

Extensive experience with health authorities, especially FDA / CBER , regulatory processes, documents, and requirements, such as INDs, clinical trial applications, NDA / BLA, meeting request procedures, and materials

Proven ability to manage and grow a team.

Strong business acumen.

Maintains professional decorum in all interactions with internal and external colleagues.

Must be able to provide creative solutions to problems.

Must be able to work in a multi-disciplinary environment.

Must have strong interpersonal and communication skills.

Exhibits strong conflict-resolution skills.

Must be able to work effectively in a multi-cultural, global team environment.

Education and / or Experience

BS Degree or equivalent. Advanced degree desirable (MS, PhD, PharmD, or JD).

Minimum 15 years regulatory experience in drug clinical development and / or promotion / advertising, US labeling.

Extensive hands-on experience in the development of key regulatory submissions, including NDAs, BLAs, MAAs, and INDs, as well as interacting with regulatory authorities and supporting site / sponsor regulatory inspections.

At least 7 years of experience in a leadership Regulatory Affairs position having direct reports.

Therapeutic area experience in rare disease is preferred.

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Executive Senior Director, Regulatory Affairs

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