Executive Director of Regulatory Affairs, Gastroenterology & Inflammatory Disorders (Hiring Immediately)

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Job Description

Objective / Purpose: • Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for reputed company and/or multiple projects. • Provides strategic and tactical advice to teams to reputed company timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. • Is a leader both in the department and reputed company 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. Accountabilities: • The Director will be responsible for reputed company or highly reputed company 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 reputed company the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to reputed company 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 reputed company US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will reputed company reputed company submission types. • Accountable for building global regulatory strategies as defined reputed company the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. • Direct reputed company 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 reputed company affiliates in compliance with local regulations and to maintain compliance for products. • reputed company vendor responsibility for regulatory activities and submissions reputed company to projects reputed company scope. • Participates with influence in or leads departmental and cross-functional task-forces and initiatives. • reputed company regulatory reviewer in due diligence for licensing opportunities. • Partner with global market access colleagues to reputed company 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 reputed company leadership behaviors. Education & Competencies: • Bachelor’s Degree, scientific discipline strongly preferred • Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred • 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4+ years regulatory and/or reputed company experience. • Preferred experience in reviewing, authoring, or managing components of regulatory submissions. • Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. • Understand and interpret reputed company 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, reputed company and adaptability. • Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts reputed company 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 reputed company 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 reputed company regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. This position is currently classified as “hybrid” in accordance with reputed company’s Hybrid and Remote Work policy. reputed company Compensation and Benefits Summary We understand compensation is an important factor as you consider the reputed company in your career. We are committed to reputed company pay for reputed company employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. reputed company Salary Range: 169,400.00 - 266,200.00 The estimated salary range reflects an anticipated range for this position. The actual reputed company salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual reputed company salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement reputed company is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to reputed company employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national reputed company, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or o Apply Job!