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Taiho Oncology, Inc. · 1 day ago

Director, Regulatory Affairs CMC

Princeton, NJ

Full-time

Hybrid

Director/Executive

$212K/yr - $250K/yr

15+ years exp

Taiho Oncology is on a mission to improve the lives of patients with cancer. They are seeking a Director for Regulatory Affairs CMC to manage global regulatory CMC activities, provide strategic regulatory guidance, and ensure compliance with global regulatory requirements.

BiotechnologyHealth CareMedicalOncologyPharmaceutical

Comp. & Benefits

Responsibilities

Independently develops global regulatory CMC Strategies and Risk Assessments and communicate such strategies and risks to TPC and also within TOI

Prepare strategy and plans for FDA/EMA meetings in coordination with TPC and TOI members. Ensure rapid preparation and approval of CMC meeting related submissions to health agencies and resolution of queries. Participate in interactions and negotiations with regulatory authorities

Provides strategic regulatory guidance, especially CMC during drug development, approval and post approval in coordination with both internal and external staff, consultants and contractors

Ensures that the pharmaceutical development, manufacturing and testing of drug substance and drug product conforms to current global regulatory requirements

Leads, coordinates and prepares CMC submissions to regulatory authorities globally except Asia

Review submissions for regulatory compliance and completeness

Responsible for developing submission strategy for assigned projects and specific areas of expertise with assistance

Responsible for development of strategy and risk assessments for CMC activities (e.g., INDs, IMPDs, MAAs/Post approval Submissions). Effectively influences CMC teams to achieve implementation of appropriate regulatory strategies. Builds positive and favorable relations with CMC teams to implement favorable outcomes in the shortest possible time

Assists in development of processes including standard operating procedures for regulatory and other related areas

In conjunction with Quality Assurance, manages regulatory compliance for sponsor activities for CMC, drug supply, documentation, Good Manufacturing Practices (GMP) requirements as needed

Provides regulatory support to PAI preparation and Inspection

Directs and coordinate regulatory activities of external consultants in consultation with Global Executive Director or designee

Prepare project and/or status reports as assigned

Ensures that development strategies meet global regulatory requirements over the lifecycle of the TOI programs

Keep abreast of current global regulations and guidelines

Perform other duties as assigned

Qualification

CMC regulatory experienceRegulatory submissionsPharmaceutical developmentGlobal regulatory requirementsManufacturing PracticesRegulatory strategy developmentNegotiation with regulatory agenciesDetail orientationCommunication skillsOrganizational skillsInterpersonal skillsProject management knowledge

Required

Bachelor's degree in pharmacy, chemistry or related scientific discipline or equivalent experience is required

Technical and scientific expertise in a discipline related to pharmaceutical development, manufacturing, or quality

Fifteen years' previous CMC drug development and regulatory experience (both US and EU preferably) with at least 8-10 years in CMC regulatory or related area

Substantial experience leading and preparing Chemistry, Manufacturing and Control (CMC) documentation for regulatory filings

Experience in developing and implementing CMC regulatory strategy for early and late stage of development products with strong emphasis of approval through launch to post marketing commercial support

Knowledge of and experience interacting and negotiating with regulatory agencies, particularly the FDA

Strong working knowledge of global CMC regulatory requirements and submission processes

In depth knowledge of global regulatory requirements for pharmaceutical development and manufacturing

Strong working knowledge of current Good Manufacturing Practices (cGMP)

Detail orientation, with emphasis on accuracy and completeness

Excellent written and oral communication

Ability to reason, persuade and negotiate with regulatory authorities

Good organizational and planning skills; drive for results

Good interpersonal skills that involve working well in a team environment and the ability to lead others

Working knowledge of project management