Director, Regulatory Affairs CMC

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It’s our work, our passion, and our legacy. We invite you to join us.

Hybrid

Employee Value Proposition:

Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director, Regulatory CMC. Your expertise will play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life cycle and post approval projects in US, EU, Canada and more, working with colleagues in Japan and US, giving you a truly global experience that helps cancer patients every day. The size of our company allows for firsthand interaction with multiple functions within our organization, offering you a well-rounded experience and a platform to showcase and enhance your skills.

Position Summary:

With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development, approval and post approval processes and commercialization, in coordination with internal staff, Japanese colleagues at Taiho Pharmaceutical Corporation (TPC) and external consultants/contractors. Manages the development and preparation of high-quality regulatory submissions including NDA's, MAA's, INDs, CTAs, DMFs, ASMFs, etc. and ensures that they conform to current GMP and meet global regulatory requirements. The incumbent may participate in interactions and negotiations with regulatory authorities during the drug development and approval processes following an agreed upon plan.

Performance Objectives:

• 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.

Education/Certification Requirements:

• Bachelor’s degree in pharmacy, chemistry or related scientific discipline or equivalent experience is required.
• MSc, PhD or PharmD preferred.

Knowledge, Skills, and Abilities:

• 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.
• Experience in biologics and/or antibody drug conjugate a plus for future studies, if applicable.
• Previous experience in pharmaceutical development and manufacturing and management of CROs is desirable.
• 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.
• The incumbent in this position may be required to perform other duties, as assigned.

The pay range for this position at commencement of employment is expected to be between $212,500 - $250,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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