Associate Director, Global Regulatory Project Management – Oncology

Job not on LinkedIn

October 28

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $153.6k - $241.3k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Takeda

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• Partnering with the program Global Regulatory Lead (GRL) to co-lead Global Regulatory Team (GRT) meetings • Ensure Global Product Team (GPT) regulatory goals are cascaded • Proactively drive GRT and SWG project teams • Develop and maintain integrated regulatory project plans • Provide regulatory operational support activities for assigned programs • Ensure out-sourced regulatory operational deliverables meet all timelines • Prepare and deliver reports on major regulatory milestones • Collaborate with the GRL in presenting operational strategies

🎯 Requirements

• Bachelors degree required • Emphasis in Science preferred • Advanced degree preferred • Minimum of 8 yrs related experience (e.g. Regulatory Project Management) • Preferably with 4 Yrs in Global Regulatory Affairs • Experience working on late-stage filings preferred • Advanced education or credentialing in regulatory affairs and project management preferred • Significant experience in global drug development regulations • At least two major eCTD registrations in the USA or more jurisdictions • Understanding of scientific principles and regulatory standards

🏖️ Benefits

• medical, dental, vision insurance • 401(k) plan and company match • short-term and long-term disability coverage • basic life insurance • tuition reimbursement program • paid volunteer time off • company holidays • up to 80 hours of sick time • up to 120 hours of paid vacation