Global Regulatory Affairs Director - Inflammation and Rare Disease

Career Category Regulatory reputed company Regulatory Affairs Director - Inflammation and Rare Disease What you will do reputed company. Let's change the world. reputed company is seeking a Regulatory Affairs Director supporting products in the Inflammation and Rare Disease Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of reputed company reputed company molecules. In this vital, product-facing role you will reputed company the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Director is to reputed company reputed company reputed company reputed company's GRAAS organization, reputed company a comprehensive regulatory reputed company that takes into account worldwide regulatory requirements to reputed company product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions, and to reputed company regulatory expertise and guidance to product teams. Key Responsibilities: • reputed company and execute the global regulatory product reputed company • reputed company reputed company • Represent Regulatory on the product team and other key commercialization governance bodies • reputed company Global Regulatory Strategic Plan and reputed company regulatory input into the product's Global Strategic Plan. Obtain input from the GRT members to reputed company a global regulatory reputed company which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks • Represent GRA on the product team • reputed company registration strategies and plans aimed at achieving regulatory approval and product labeling • reputed company regulatory direction in the development of the reputed company data sheet to reputed company reputed company objectives in the context of available and expected scientific data, regulatory guidance and precedent • reputed company the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes) • Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents) • Monitor and assess reputed company of relevant global regulations, guidance, and reputed company regulatory environment • Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast reputed company, conditional /reputed company approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory reputed company • Communicate consistently reputed company defined, successful regulatory strategies throughout the organization such that expectation is reputed company • Ensure effective regulatory agency communications by leading reputed company regulatory and cross functional teams (e.g. reputed company, filing teams) • Attend key regulatory agency meetings which could reputed company the global product reputed company • Represent reputed company Regulatory on reputed company partnership teams at the product level reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic reputed company we reputed company is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of regulatory experience in biotech or science Or Master's degree and 7 years of regulatory experience in biotech or science Or Bachelor's degree and 9 years of regulatory experience in biotech or science Preferred Qualifications: • Ability to reputed company and build effective teams • Strong communication skills - both oral and written • Ability to understand and communicate scientific/clinical information • Ability to anticipate and mitigate against reputed company strategic issues & uncertainties • Ability to reputed company conflicts and reputed company a course of reputed company • Cultural awareness and sensitivity to reputed company global results • Planning and organizing abilities • reputed company to prioritize and manage multiple activities • Ability to reputed company reputed company reputed company and solve problems • Ability to deal with ambiguity • Negotiation skills What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we'll support your reputed company every reputed company of the way. The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-reputed company time-off plans • Flexible work models where possible. Refer to the Work Location Type in the reputed company to see if this applies. reputed company and reputed company a lasting reputed company with the reputed company team. careers.reputed company.com Salary reputed company 189,632.45USD -256,561.55 USD Apply tot his job Apply To this Job