- Serves as a liaison to FDA and provides strategic input to CROs and their regional regulatory leads responsible for ex-US regulatory activities. Provide oversight of regulatory consultants and vendors where applicable.
- Provides regulatory strategic support and guidance to assigned project teams.
- Performs research on regulatory precedence and competitive intelligence as needed.
- Contributes to identification of potential issues/gaps and proposes creative risk mitigation strategies to address gaps affecting optimal and timely submissions and approvals.
- Assess and communicate regulatory requirements to assigned project teams and management to ensure development activities are in compliance with applicable regulations and guidelines.
- Supports and manages regulatory CROs in the planning and execution of US and ex-US global health authority interactions including support in preparation and submission of INDs and amendments, NDAs and supplements, meeting requests, briefing books, meeting preparations, paedatric investigational plans (PIPs), Orphan Drug Designation applications, Fast Track applications, support for accelerated approvals, etc.
- Assists and/or leads in planning and execution of major and life-cycle management maintenance submissions and responses to regulatory authorities related to INDs, IND amendments, NDAs and supplements within company timelines and in accordance with regulations and guidelines.
- Interprets and communicates health authority correspondence effectively and quickly to senior leadership and assigned project teams.
- Responsible for the goals, performance assessments, management and professional development of RA direct reports to support assigned projects.
- Provide direction, advice, coaching and mentoring of direct reports as needed.
- Responsible for the management and oversight of external consultants (i.e., regulatory, clinical, nonclinical, legal, medical writers), CROs and contractors to provide regulatory support on assigned projects.
- Evaluate and improve internal processes for better utilization of external support.
- Assess and align RA activities/resources with R&D project needs.
- Monitor FDA Regulations/EMA Guidelines that are applicable to NS Pharma activities and provide to teams as applicable.
- Oversee and manage activities on assigned projects including on-going resource evaluation (including internal and external/consultants), building internal/external capabilities.
- Participate in budget planning, contract management and review and approval of invoices.
- Contribute to regulatory affairs department long term planning.
- Build good relationships with key stakeholders to ensure effective communication close cross-functional collaboration to support RA goals and R&D teams on assigned projects.
- Driven self-starter, able to prioritize and work well in a fast-paced environment to multi-task, problem solve, and motivate and lead others.
- Willingness to take on tasks outside normal responsibilities with a positive attitude to get the job done.
- Experience developing global regulatory strategies, as well as, lead and or contribute to hands-on day-to-day submissions activities.
- Able to present to senior leadership clearly, succinctly, with open-mindedness and willingness to defend difficult positions.
- Strong sensitivity for a multicultural and multinational environment.
- Experience in successfully leading teams and the ability to broadly represent regulatory affairs on project teams.
- Experience in submission and maintenance of INDs, preparation of FDA correspondence and regulatory documents. Preparation and review of FDA meeting requests, briefing documents, designation requests and other regulatory documents.
- Excellent written and verbal communication skills, and strong analytical skills.
- Experience with rare diseases, orphan drug products, accelerated approval process, oncology, renal disease, endometriosis, and vasculitis product development is a plus.
- Experience with NDA submissions and post-approval requirements is a plus.
- Experience with labeling and/or global target product profiles is a plus.
- Advanced degree strongly preferred (PharmD, MD, PhD) with 10 or more years of related pharmaceutical product regulatory experience in biotech/pharma branded industry including 5 or more years of new drug development experience.
- Experience managing regulatory CROs, consultants and or direct reports.
- Experience interacting with the FDA and ex-US health authorities (with the exception of Japan).
- Working knowledge of prescription drug laws, ICH guidelines, FDA regulations and other health authority guidances/guidelines.
- Experience in rare disease/accelerated approvals preferred.
- Regulatory Affairs Certification is a plus.
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Description
Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The Director will manage and lead regulatory strategy and submission related activities of assigned projects and manage direct reports, consultants and CROs to support US and ex-US (with the exception of Japan) investigational and marketed product submissions. The Director will also ensure project goals are developed, timelines are managed, and issues are appropriately raised and resolved in a timely manner. The Director will represent regulatory affairs on assigned project teams and support R&D and clinical research activities. Must be able to work on-site 2 days per week.
Essential Duties and Responsibilities(Include but not limited to the following. Other duties may be assigned.)
Supervisory Responsibility
Qualifications
Education and/or Experience
