Apply on Employer Site

TakedaPharmaceutical Nordics AB · 8 hours ago

Associate Director, Global Regulatory Affairs - GI & Inflammation

Boston, MA

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$154K/yr - $241K/yr

6+ years exp

Takeda Pharmaceutical Nordics AB is a leading company in the pharmaceutical industry, and they are seeking an Associate Director for Global Regulatory Affairs specializing in GI and Inflammation. The role involves defining and leading global regulatory strategies, providing tactical advice, and ensuring compliance with regulatory requirements while managing complex projects and teams.

Pharmaceuticals

Responsibilities

Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects

Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements

Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable

Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts

The Associate Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible

Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy

Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner

Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions

Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types

Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs

Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed

Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products

Oversee vendor responsibility for regulatory activities and submissions related to projects within scope

Participates with influence in or leads departmental and cross-functional task-forces and initiatives

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

Qualification

Regulatory strategyFDA submissionsPharmaceutical industry experienceDrug development processScientific interpretationOral communicationWritten communicationNegotiation skillsTeam collaborationAdaptability

Required

Bachelor's Degree, scientific discipline strongly preferred

Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred

6+ years of pharmaceutical industry experience. This is inclusive of 4+ years of regulatory experience

Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus

Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy

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

Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability

Demonstrates strong 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

Must work well with others and within global teams

Able to bring working teams together for common objectives

Acceptable and independent skills 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