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    Director, Gra Cmc Small Molecules

    Takeda Pharmaceutical
    10+ years
    169,400.00 - 266,200.00
    Boston
    10 Nov. 27, 2024
    Job Description
    Job Type: Full Time Education: BS/BA/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: Director, GRA CMC Small Molecules
    Location: Boston, MA (Hybrid Work)

    About Takeda:
    At Takeda, we are focused on transforming patient care through innovative specialty pharmaceuticals and best-in-class patient support programs. We are a global top employer committed to fostering an inclusive, collaborative work environment where innovation and excellence are at the forefront. Our teams are united by a shared goal to deliver better health and a brighter future to people worldwide.

    Role Overview:
    As a Director in Global Regulatory Affairs (GRA) CMC for Small Molecules, you will oversee the development and execution of regulatory CMC strategies across all stages of clinical development and commercialization. You will lead cross-functional teams, ensuring compliance with global regulations and managing complex regulatory submissions. You will also serve as the regulatory CMC expert for new business development and play a key role in the negotiation and communication with international health authorities.

    How You Will Contribute:

    • Regulatory CMC Leadership:

      • Independently plan, execute, and manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
      • Lead teams in defining CMC content for regulatory submissions and ensure compliance with EMA/FDA/ICH/WHO/global regulations.
      • Provide regulatory CMC expertise during Health Authority meetings and product development discussions.
      • Lead or contribute to the development and enhancement of business processes within the regulatory CMC area.
      • Evaluate and contribute to new business development opportunities and participate in due diligence teams.

    • Health Authority Interactions:

      • Represent Takeda in Health Authority meetings, leading CMC preparation activities and supporting regulatory submissions.
      • Build and maintain strong relationships with Health Authority representatives and regulatory agencies.
      • Manage communication and negotiations with international regulatory agencies, ensuring compliance with global regulatory requirements.

    • Team Leadership & Development:

      • Lead and develop staff, providing professional development and project oversight.
      • Make critical decisions on regulatory issues and provide strategic guidance to drug development, registration, and post-market teams.

    • Collaboration & Stakeholder Management:

      • Maintain constructive relationships with internal and external colleagues, including Takeda teams, alliance partners, and health authority representatives.
      • Ensure key stakeholders are informed of developments that may impact regulatory success.

    Minimum Requirements/Qualifications:

    • Education & Experience:

      • BS/BA in a scientific discipline (advanced degree preferred).
      • 10+ years of pharmaceutical regulatory CMC experience, including leadership roles in late-stage development and international experience.
      • Extensive experience with small molecules and regulatory CMC requirements for global drug development and post-market support.
      • Proven ability to liaise with regulatory agencies, especially in product development meetings, and experience with international regulatory frameworks.

    • Skills & Expertise:

      • Strong understanding of regulatory CMC requirements and scientific principles related to drug development.
      • Proven ability to provide strategic regulatory guidance across all stages of product development.
      • Leadership skills with the ability to solve complex problems and navigate challenging regulatory issues.
      • Excellent communication skills, including the ability to engage with stakeholders at all levels, both internally and externally.

    • Travel Requirements:

      • Willingness to travel up to 10-30%, including overnight trips as necessary.

    Compensation & Benefits:

    • Salary Range (U.S. Based Location - Boston, MA):
      • $169,400.00 – $266,200.00 (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 is a forward-thinking, patient-focused company committed to creating a diverse, equitable, and inclusive workforce. We provide our employees with the opportunity to grow professionally through life-changing work. Join us in delivering better health and a brighter future for people worldwide.

    EEO Statement:
    Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants, without regard to race, gender, sexual orientation, disability, and other protected statuses.

    Apply now and become part of a team dedicated to transforming patient care!

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