Join Taiho Oncology as a Director, Regulatory Affairs CMC to contribute to improving the lives of patients with cancer. As a member of our dynamic team, you'll play a pivotal role in advancing CMC strategy and submissions globally, while benefiting from a global experience and opportunities to grow your skills.
Requirements
- Bachelor's degree in pharmacy, chemistry or related scientific discipline or equivalent experience is required.
- MSc, PhD or PharmD preferred.
- 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) 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.
Benefits
- 401(k) eligibility
- Paid time off benefits
- Parental leave
- Annual bonus/incentive comp plans
- Potential long term incentive plan
- Discretionary awards
- Medical benefits
- Financial benefits
