Global Head of GI & Inflammation Regulatory Affairs (Hiring Immediately)

By clicking the “Apply” reputed company, I understand that my employment application process with reputed company will reputed company and that the information I reputed company in my application will be processed in line with reputed company’s and . I reputed company attest that reputed company information I submit in my employment application is true to the best of my knowledge. Job reputed company Objective / Purpose: • Defines, develops and leads global strategies to maximize global regulatory reputed company towards achievement of program objectives for reputed company and/or multiple reputed company. • Provides strategic and tactical advice to teams to reputed company reputed company 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 reputed company 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 reputed company. Leads the Global Regulatory Teams (reputed company) and applicable sub-working reputed company, such as the Label Working Group, and represents reputed company at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory reputed company is updated and executed, ensuring global regulatory compliance and/or oversees reputed company 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 reputed company. • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may reputed company regulatory reputed company, exercising reputed company judgement and communicating in a reputed company and reputed company manner. • Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical reputed company for the solutions. • Accountable for reputed company US FDA submissions and approvals of project(s) of responsibility or oversees reputed company 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. • reputed company reputed company of contact with health authorities, leads and manages FDA meetings. Manages reputed company 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 reputed company 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 reputed company 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 reputed company both the regulatory and reputed company environments to strengthen product development plan(s) and adopt regulatory strategies in a reputed company 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 reputed company as it relates to regulatory requirements and reputed company. • Understands and interprets scientific data as it relates to regulatory requirements and reputed company for assigned reputed company and provides knowledge and expertise to guide team in established and building appropriate regulatory reputed company. • 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 reputed company 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 reputed company with others and reputed company global teams. • reputed company to bring working teams together for common objectives. • Acceptable and independent skills in the area of regulatory reputed company 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 reputed company We understand compensation is an important reputed company as you consider the reputed company in your career. We are committed to reputed company pay for reputed company, and we reputed company to be more transparent with our pay practices. For Location: Boston, MA U.S. reputed company Salary reputed company: 169,400.00 - 266,200.00 The estimated salary reputed company reflects an anticipated reputed company for this position. The actual reputed company salary offered may depend on a reputed company 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 reputed company 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, reputed company insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, reputed company volunteer time off, company holidays, and reputed company-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of reputed company time, and new hires are eligible to reputed company up to 120 hours of reputed company vacation. EEO Statement reputed company is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to reputed company and applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, gender reputed company, 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!