Associate Director - Global Regulatory Lead, GI & Inflammation

Takeda; Cambridge (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

An established industry player is seeking an Associate Director, Global Regulatory Lead, to spearhead regulatory strategies for complex projects in the GI and Inflammation sectors. This pivotal role involves providing strategic and tactical guidance, ensuring compliance with evolving regulations, and managing FDA submissions. The ideal candidate will possess strong communication and negotiation skills, with a proven track record in the pharmaceutical industry. Join this innovative firm and contribute to impactful projects that shape the future of healthcare.

Qualifications

• 6+ years in the pharmaceutical industry with at least 4 years in regulatory roles.
• Strong understanding of drug development and regulatory requirements.

Responsibilities

• Lead global regulatory strategies and manage FDA submissions.
• Provide strategic advice to ensure compliance of programs.

Skills

Regulatory Submissions

Strategic Thinking

Communication Skills

Negotiation Skills

Team Leadership

Education

Bachelor’s Degree in Scientific Discipline

PharmD, PhD, or MD

Job description

Associate Director - Global Regulatory Lead, GI & Inflammation

Join Takeda as an Associate Director, Global Regulatory Lead, GI & Inflammation where you will define, develop, and lead global strategies to maximize regulatory success for complex and/or multiple projects.

Responsibilities include:

• Providing strategic and tactical advice to ensure timely development and compliance of programs.
• Leading cross-functional initiatives and influencing the field within R&D.
• Managing global regulatory strategies, including leading GRTs and representing them in project meetings.
• Ensuring regulatory strategies are updated and compliant with changing regulations.
• Overseeing US FDA submissions and approvals, managing FDA meetings, and collaborating with regional leads and vendors.
• Participating in or leading departmental and cross-functional initiatives.
• Leading or supporting due diligence for licensing opportunities.
• Partnering with market access colleagues for interactions with regulatory and health authorities.
• Monitoring trends affecting regulatory and access environments to inform product development.

Minimum qualifications:

• Bachelor’s degree in a scientific discipline; advanced degrees (PharmD, PhD, MD) preferred.
• 6+ years in the pharmaceutical industry, including at least 4 years in regulatory roles.
• Experience with regulatory submissions and a solid understanding of drug development and regulatory requirements (FDA, EU, Canada, ROW).
• Strong communication, negotiation, and strategic thinking skills.
• Ability to work effectively within global teams and lead regulatory strategies.

Additional details:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job functions: Other
• Industries: Pharmaceutical Manufacturing, Biotechnology Research, Research Services