Director - Global Regulatory Affairs - Precision Medicine and Digital Health

March 13

🍂 Massachusetts – Remote

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

💵 $169.4k - $266.2k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

Apply Now

Receive Emails with Similar Jobs

Takeda

WebsiteLinkedInAll Job Openings

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.

Pharmaceuticals • Therapeutics • Oncology • Gastroenterology • Vaccines

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• Responsible for providing strategic guidance and oversight for global regulatory strategies. • Ensure effective collaborations with various groups for development and commercialization efforts. • Overseeing precision medicine and digital health efforts for assigned programs. • Representing Global Regulatory Affairs function in senior level interactions and meetings. • Identifying regulatory requirements and providing guidance to global development teams.

🎯 Requirements

• Solid scientific background, PhD., M.D., PharmD, MS. • A minimum of 8 years of pharmaceutical industry experience (6 years of regulatory experience). • Expert knowledge of device development, registration and maintenance regulations. • Comprehensive understanding of biomarker strategies and implications for drug development. • Successful interactions with FDA, EMA, Notified Bodies, regarding device submissions. • Strong communication, collaboration, negotiation, problem solving, and interpersonal skills.

🏖️ Benefits

• Eligible for short-term and/or long-term incentives. • Eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match. • Short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program. • Paid volunteer time off, company holidays, and well-being benefits, among others. • Eligible to receive up to 80 hours of sick time per calendar year. • New hires are eligible to accrue up to 120 hours of paid vacation.