Director, Regulatory Affairs CMC

About the role

Join our dynamic and expanding mid-size company as the Director for Regulatory CMC, directly reporting to the Executive Director, Regulatory CMC. Your expertise will play a pivotal and visible role in advancing CMC strategy and submissions for developmental, lifecycle, and post-approval projects in the US, EU, Canada, and beyond. Collaborate with colleagues in Japan and the US to gain a truly global experience while making a daily impact on cancer patients. The size of our company allows for direct interaction with multiple functions, offering a well-rounded experience and a platform to showcase and enhance your skills.

Responsibilities

• Independently develop global regulatory CMC strategies and risk assessments, communicating these to Taiho Pharmaceutical Corporation (TPC) and within Taiho Oncology Inc. (TOI).
• Prepare strategy and plans for FDA/EMA meetings in coordination with TPC and TOI members, ensuring rapid preparation and approval of CMC meeting-related submissions to health agencies and resolution of queries.
• Participate in interactions and negotiations with regulatory authorities.
• Provide strategic regulatory guidance, especially for CMC, during drug development, approval, and post-approval processes in coordination with internal and external staff, consultants, and contractors.
• Ensure pharmaceutical development, manufacturing, and testing of drug substance and drug product conform to current global regulatory requirements.
• Lead, coordinate, and prepare CMC submissions to regulatory authorities globally (excluding Asia).
• Review submissions for regulatory compliance and completeness.
• Develop submission strategies for assigned projects and specific areas of expertise.
• Create strategy and risk assessments for CMC activities (e.g., INDs, IMPDs, MAAs/Post-approval submissions).
• Influence CMC teams to implement appropriate regulatory strategies and build positive relations to achieve favorable outcomes efficiently.
• Assist in developing processes, including standard operating procedures for regulatory and related areas.
• Manage regulatory compliance for sponsor activities related to CMC, drug supply, documentation, and Good Manufacturing Practices (GMP) in conjunction with Quality Assurance.
• Provide regulatory support for Pre-Approval Inspection (PAI) preparation and inspection.
• Direct and coordinate regulatory activities of external consultants in consultation with the Global Executive Director or designee.
• Prepare project and/or status reports as assigned.
• Ensure development strategies meet global regulatory requirements over the lifecycle of TOI programs.
• Stay abreast of current global regulations and guidelines.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in pharmacy, chemistry, or a related scientific discipline (or equivalent experience) is required; MSc, PhD, or PharmD preferred.
• Fifteen years of previous CMC drug development and regulatory experience (both US and EU preferred), with at least 8-10 years in CMC regulatory or a related area.
• Substantial experience leading and preparing Chemistry, Manufacturing, and Control (CMC) documentation for regulatory filings.
• Experience developing and implementing CMC regulatory strategy for early- and late-stage development products, with a strong emphasis on 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 conjugates is a plus.
• Previous experience in pharmaceutical development and manufacturing and management of Contract Research Organizations (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).

Skills

• 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.
• Strong interpersonal skills, including the ability to work well in a team environment and lead others.
• Working knowledge of project management.

Pay

The pay range for this position at commencement of employment is expected to be between $212,500 and $250,000 annually. Base pay may vary depending on market location, job-related knowledge, skills, and experience. The total compensation package may also include annual bonus/incentive compensation, potential long-term incentive plans, and discretionary awards.

Benefits

• Full range of medical, financial, and other benefits, including 401(k) eligibility.
• Various paid time off benefits, such as vacation, sick time, and parental leave.

Locations: Princeton, NJ or Pleasanton, CA (hybrid role).