Director – Global Regulatory Affairs – CMC Small Molecules

Director – Global Regulatory Affairs – CMC Small Molecules

Requirements

• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
• 10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead with late stage development, international experience strongly preferred.
• Significant Small Molecule experience.
• Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.
• Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Demonstrates leadership, problem-solving ability, flexibility and teamwork.
• Exercises good judgement in elevating and communicating actual or potential issues to line management.
• Willingness to travel to various meetings, including overnight trips.
• Requires approximately up to 10-30% travel.

Responsibilities

• 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.
• Member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization.
• Lead team members that defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements.
• Lead and/or contribute to business process development and enhancement.
• Evaluate new business development opportunities or participate on due diligence teams.
• Develop and maintain constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives.
• Responsible for ensuring that project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Exercise good judgement in elevating and communicating actual or potential issues to line management.
• Communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
• Represent Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters.
• Interact directly with international Health Authorities, as required.
• Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred.
• Manage and develops staff, if required, including staff professional development and project oversight accountability.
• Evaluate change proposals for regulatory impact and filing requirements.

Preferred Qualifications

• International experience preferred.