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Vice President, Regulatory Affairs - Remote - WFH

Company: Get.It Recruit - Administrative
Location: New York
Posted on: February 12, 2024

Job Description:

Were on a mission to transform how life-changing therapies are brought to those who need them most. Unlike the traditional Clinical Research Organizations (CRO), we harness new technologies, deep scientific expertise, and operational efficiency to enhance the development process of groundbreaking therapies. Our unique approach integrates clinical trial execution with advanced scientific knowledge and data sciences, setting us apart in our quest to improve the speed, cost-effectiveness, and success rates of therapy development.As we continue to expand, were in search of a Vice President of Regulatory Affairs to lead our global regulatory strategies. This role is pivotal in ensuring compliance with governmental regulatory requirements worldwide and in leveraging regulatory knowledge to support product development from concept to market.What Youll Do:Regulatory Strategy and Oversight: Craft and implement strategies for the preparation and submission of regulatory documents, ensuring timely execution. Youll lead the development of global regulatory strategies for clinical programs, aiming for successful global registration.Regulatory Intelligence: Offer expert analysis on regulatory developments, ensuring the company and stakeholders are informed of regulatory statuses and significant issues. Youll be the go-to for guidance on regulatory documents, guidelines, and compliance.Leadership: Guide and mentor the Regulatory Affairs team, fostering growth and excellence. Youll oversee the departments development, manage resources, and contribute to business development with a focus on regulatory consulting.Cross-Functional Collaboration: Work closely with various departments and stakeholders to ensure a cohesive approach to regulatory strategy and compliance. Your leadership will be key in preparing for health authority meetings and submissions.Who Were Looking For:Experienced Professional: With at least 15 years in regulatory or clinical development within the pharmaceutical/biotechnology field. Your deep understanding of the drug development process and regulatory milestones will be essential.Strategic Thinker: Your ability to navigate FDA, EMA, and other global health authority requirements strategically and operationally will be crucial. Experience in developing global strategies for innovative therapies is highly valued.Educated and Skilled: A Bachelors degree in life sciences or medicine is required, with an advanced degree preferred. Your expertise in regulatory document preparation, including INDs, NDAs, BLAs, and more, will be pivotal.Dynamic Leader: Proven ability to lead, mentor, and develop a high-performing team. Your strong interpersonal skills will enable effective collaboration across functions and with external stakeholders.Why Join Us?Were at the forefront of a new era in personalized medicine, working to develop treatments tailored to individual patient needs. Our work supports innovative biotech and pharmaceutical companies in accelerating the development of these transformative treatments. By joining us, youll play a critical role in shaping the future of medicine, in an environment that values your input and nurtures your ideas.Benefits:Competitive salary range of $220,000-$298,000 USD, dependent on experience and qualifications.Eligibility for discretionary annual bonuses, comprehensive health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and generous paid time off policies.Commitment to Diversity:We are proud to be an Equal Opportunity Employer, committed to building a diverse and inclusive workplace. We make employment decisions based on merit, competence, and business needs, and we welcome applicants from all backgrounds.Accessibility:Should you require any accommodations during the application process.Full-Time$ 220,000.00 298,000.00 Per YearNo formal educational credential Get It Recruit - Administrative connects job seekers with employers and opportunities that match their qualifications. Job seekers can complete the full application process on the employers website. To learn more about the position, click our Apply Now button and begin the application process. This job is shared on behalf of the employer, and any questions about the position, salary, application process, or other details about the job should be directed to them. Vice President, Regulatory Affairs - Remote - WFH J-18808-Ljbffr

Keywords: Get.It Recruit - Administrative, New York , Vice President, Regulatory Affairs - Remote - WFH, Executive , New York, New York

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