Global Regulatory Project Manager for Late Stage Filings
22 hours ago
About the Position
We are seeking a seasoned Global Regulatory Project Manager to join our team in Massachusetts, USA. As a key member of our Global Regulatory Affairs organization, you will be responsible for managing global regulatory projects from late stage filings.
Key Responsibilities
- Partner with the Global Regulatory Lead to ensure seamless execution of global regulatory project plans and direct cross-functional project submission working groups to deliver successful submissions/filings and outcomes with Health Authorities (HA) for early to late phase programs.
- Lead high-performance teams and mentor colleagues to identify and recommend solutions to problems and pathways to overcome timeline concerns and barriers for strategy execution.
- Develop and maintain integrated regulatory project plans and integrated SWG plans, ensuring out-sourced regulatory operational deliverables by third parties and vendors meet all program timelines and company standards.
- Collaborate with the GRL to prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, mitigation management, and proposed solutions to support decision-making.
- Elevate high-impact business-critical issues and potential critical issues together with proposed plans of action, as appropriate, in a timely manner to the GRL and management.
- Drive continuous improvement by recommending, planning, and implementing process changes through proactive engagements with cross-functional team members, Global Regulatory Affairs TAU colleagues, and Global Regulatory Project Management and Strategic Planning (RPMSP) head.
Requirements
- Bachelor's degree required, with an emphasis in Science preferred; advanced degree preferred.
- A minimum of 8 years of related experience, preferably with 4 years in Global Regulatory Affairs.
- Experience working on late-stage filings is highly preferred.
- Demonstrated expert experience leading high-performance teams and mentoring colleagues.
- Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology, and process is required.
- At least two major eCTD registrations and several minor filing experiences in the USA or more jurisdictions.
- Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support is needed.
About Us
Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT domains. We foster a collaborative workplace where our teams are united by an unwavering commitment to deliver better health and a brighter future to people around the world.
Estimated Salary Range: $149,100 - $234,300 per year.
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