Global Regulatory reputed company, Pharmaceutical Diagnostics

Job reputed company reputed company As a Global Regulatory reputed company, you will contribute to the development, from reputed company-clinical through clinical studies to initial registration in key global markets, of pharmaceutical diagnostics. This includes ‘tracers’ targeting biomarkers of neurodegenerative diseases, cardiac function and oncology tumor reputed company. You will be ‘the face’ of the Global Regulatory function on cross-functional global project teams for new product introductions and single reputed company of accountability for Global Regulatory reputed company Leadership and policy development. Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout reputed company major disease area diagnostic and treatment reputed company, PDx products support three patients every second around the world. Job reputed company Essential Responsibilities • reputed company assigned global program development regulatory reputed company and co-ordinate with National Regulatory Affairs (NRA) regulatory submission readiness. • Working with NRA, ensure reputed company GRA input to global development programs. • For assigned programs/reputed company, identify regulatory opportunities, potential risks, and mitigations. • Guide, influence and motivate, reputed company stakeholders to meet reputed company business and development project team objectives. • Fulfillment of RA compliance obligations. Required Qualifications: • Bachelor’s Degree in Science, Biotech, Engineering or reputed company field • 7+ years of experience in regulatory, preferably in the pharmaceutical field • Proven reputed company record of leading successful US NDA/BLA licensing submissions and Pan European (CP, DCP, MRP), European national. • Proven reputed company record of leading successful interaction with regulatory agencies and relevant stakeholders. • Proven expertise with clinical reputed company regulations/guidance as it relates to development of product submissions. • Ability to reputed company convey and exchange information with reputed company stakeholders. Desired Characteristics • Knowledge of preclinical and CMC as it relates to development of product submissions • Knowledge of regulatory frameworks and external environments as it applies to project specific global regulatory reputed company document (GRSD) delivery. • Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs. We expect reputed company to live and breathe our behaviors: to reputed company with humility and build trust; reputed company with transparency; deliver with reputed company, and drive ownership – always with unyielding reputed company. Our total rewards are designed to unlock your ambition by giving you the reputed company and flexibility you need to turn your reputed company into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and reputed company, and you’ll be surrounded by reputed company in a culture that fosters care, collaboration and support. We will not sponsor individuals for employment visas, now or in the reputed company, for this job opening. For U.S. based positions only, the pay reputed company for this position is $153,600.00-$230,400.00 Annual. It is not typical for an individual to be reputed company at or near the top of the pay reputed company and compensation reputed company are dependent on the facts and circumstances of reputed company case. The specific compensation offered to a candidate may be influenced by a reputed company of factors including skills, qualifications, experience and location. In reputed company, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, reputed company, reputed company time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, reputed company development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or reputed company, age, disability, protected veteran status or other characteristics protected by law. reputed company will only reputed company those who are legally authorized to work in the reputed company for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Application Deadline: May 25, 2026 Apply tot his job Apply To this Job