Senior Director, Global Regulatory Affairs, Neuroscience

Takeda•Boston, MA

4d•Hybrid

About The Position

The Senior Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio. This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior/Director also will lead discussions of regulatory strategy with senior leadership of the TAU and where appropriate R&D. Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Represents Takeda as applicable in industry/regulatory forums to lead regulatory innovation.

Requirements

Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD). BA acceptable with significant Industry experience.
12+ years of pharmaceutical industry experience inclusive of 10 years of regulatory experience or a combination of 8+ years of regulatory and related experience.
Experience in Neuroscience preferred.
Understands and works effectively with a Global Regulatory Team to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations.
Ability to advise on applicable regulations and guidance documents, including providing interpretation of these governing documents by regulators as experience is gained in practice.
Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
Demonstrated ability to work well within global teams and success leading cross-functional regulatory work products.

Responsibilities

Will be responsible for complex and potentially multiple projects within a Neuroscience TAU Franchise.
Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups and represents GRTs at project team meetings.
Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions to deliver on the proposed strategy with the project teams.
Will work closely with and report to a Neuroscience TAU Franchise Regulatory Lead and may provide oversight of direct reports or junior staff.
Effectively communicates through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders for alignment and to ensure awareness of issues that may impact regulatory success.
Responsible for proactively anticipating regulatory risks and for developing mitigation strategies in alignment with team and management; understands relative strengths, weakness, and probabilities of technical success for the mitigation strategies proposed.
The Sr Director/Director will be accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible.
Direct point of contact with health authorities, leads and manages FDA meetings.
Manages direct reports or junior staff as needed.
Leads the GRT and proactively solicits input from regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and support the project objectives.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
Participates with influence in or leads departmental and cross-functional taskforces and initiatives.
Serves as lead regulatory reviewer in due diligence for licensing opportunities.
Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
Responsible for demonstrating Takeda leadership behaviors