Global Regulatory Affairs Lead, Marketed Products – Radiopharma

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $132k - $198k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• Oversee all regulatory activities for the assigned portfolio, including variations, renewals, and regulatory commitments • Provide regulatory input and strategic impact assessment for commercial plans • Ensure compliance with global regulatory requirements and evolving health authority expectations • Provide strategic oversight to Regional Regulatory Heads and National Regulatory Affairs on territory-impacting activities • Keep Regulatory leadership and relevant stakeholders informed about significant regulatory submissions, issues, and risks • Ensure key actions in Regulatory Information Management systems are completed on time and to accepted quality standards • Plan and participate in regulatory agency meetings supporting regulatory strategy and product lifecycle activities • Lead or support forums for sharing best practices and lessons learned related to regional regulatory activities • Build internal and external stakeholder networks to influence regulatory outcomes • Interpret the external regulatory environment and regulatory precedent to optimize the portfolio • Attend key business meetings and provide appropriate regulatory representation • Gather, understand, and implement regional regulatory needs into regulatory strategies • Contribute to the regulatory budget process in alignment with business strategy

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field • Significant experience in Regulatory Affairs with strong focus on post-approval lifecycle management • Proven experience working in cross-functional global teams • Experience interfacing with global regulatory agencies • Strong communication skills • Strong project management and prioritization skills • Ability to comprehend and communicate key regulatory requirements and expectations • Ability to manage multiple activities and changes and change priorities quickly • Ability to prioritize daily, monthly, and yearly tasks according to business needs • Ability to educate and influence internal and external stakeholders • Openness to adopting digital technologies and AI-driven solutions • Experience in regulatory affairs within the radiopharmaceutical sector is desirable • Legally authorized to work in the United States • Successful completion of a drug screen, as applicable

🏖️ Benefits

• Medical, dental, and vision insurance • Paid time off • 401(k) plan with employee and company contribution opportunities • Life, disability, and accident insurance • Tuition reimbursement • Professional development • Competitive compensation • Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI) • Relocation assistance not provided