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Senior Director, Global Regulatory Lead, Gi & Inflammation

10+ years
205,100.00 - 322,300.00
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: PharmD/PhD/MD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Senior Director, Global Regulatory Lead, GI & Inflammation
Location: Boston, MA (Hybrid Work)

About Takeda:
At Takeda, we are dedicated to transforming patient care through groundbreaking specialty pharmaceuticals and innovative patient support programs. As a global top employer, we provide stimulating careers in a collaborative environment where innovation thrives. Our teams are united in their mission to deliver better health and a brighter future to people worldwide.

Role Overview:
As Senior Director, Global Regulatory Lead for GI & Inflammation, you will lead the development and execution of global regulatory strategies across multiple, complex projects. In this role, you will guide teams in achieving timely and efficient regulatory submissions while ensuring compliance with regulatory requirements. You will also be responsible for mentoring and developing direct reports and collaborating cross-functionally to drive the success of Takeda’s program objectives.

How You Will Contribute:

  • Regulatory Leadership:

    • Lead Global Regulatory Teams (GRTs) and sub-working groups (e.g., Label Working Group), and represent GRTs at project team meetings.
    • Define and provide tactical guidance for global regulatory strategies, ensuring that they are effectively implemented and maintained in line with changing regulatory requirements.
    • Proactively anticipate and address regulatory risks, offering creative solutions and strategies, including risk mitigation.
    • Serve as the direct point of contact for health authorities, manage FDA meetings and other regional health authority meetings as required.
    • Oversee all FDA submissions and approvals for assigned projects or supervise direct reports responsible for these tasks.
  • Cross-functional Collaboration:

    • Work with regulatory regional leads, business functions, and vendors to ensure regulatory submissions are compliant with local regulations.
    • Partner with global market access teams to lead interactions with regulatory, health agency, and HTA bodies on product-specific value evidence topics.
    • Participate in departmental and cross-functional task-forces, influencing key initiatives.
  • Leadership & Mentorship:

    • Lead and mentor a team of global regulatory leads responsible for the design and execution of regulatory strategies.
    • Contribute to the development of regulatory expertise within the team, providing advice and guidance on regulatory issues across multiple projects.
    • Support regulatory due diligence for licensing opportunities.

Minimum Requirements/Qualifications:

  • Education & Experience:

    • Bachelor’s Degree in a scientific discipline (advanced degree such as PharmD/PhD/MD is strongly preferred).
    • 10+ years of pharmaceutical industry experience, including at least 8 years in regulatory affairs or a combination of 6+ years in regulatory and related experience.
    • Experience in reviewing, authoring, or managing regulatory submissions across multiple regions (FDA, EU, Canada, ROW).
  • Skills & Expertise:

    • In-depth knowledge of the drug development process, regulatory requirements, and global regulatory strategy.
    • Expertise in interpreting complex scientific data and its implications for regulatory strategy.
    • Strong communication, negotiation, and leadership skills, with a track record of managing and influencing cross-functional teams.
    • Ability to proactively identify regulatory issues and develop creative solutions.
    • Demonstrated ability to bring teams together for common objectives and navigate complex global regulatory landscapes.

Compensation & Benefits:

  • Salary Range (U.S. Based Location - Boston, MA):
    • $205,100.00 – $322,300.00 (Base salary range). The actual salary offered will depend on experience, qualifications, and location.
    • Eligible for short-term and long-term incentives, medical/dental/vision insurance, 401(k) plan with company match, disability coverage, life insurance, and more.
    • Paid time off including 120 hours of vacation and up to 80 hours of sick time annually.

Why Takeda:
Takeda offers an inclusive, collaborative, and innovative work environment where you will be empowered to grow professionally while contributing to life-changing work. As a company, we value diversity, equity, and inclusion and are committed to providing equal employment opportunities to all applicants.

EEO Statement:
Takeda is an equal opportunity employer. We encourage candidates of all backgrounds to apply, regardless of race, gender, sexual orientation, disability, age, or other protected status.

If you’re interested in joining Takeda’s Global Regulatory team, apply today!