Senior Director Regulatory Affairs CMC

10 Jul, 2022

Jobs

Senior Director Regulatory Affairs CMC

Turning Point Therapeutics
San Diego, CA

About Turning Point Therapeutics:

Turning Point is a growing clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. We are applying novel small molecule design approaches integrating tumor biology and structure-based drug design to develop a new generation of proprietary targeted agents that we believe will have the potential to address important unmet medical needs for patients.

Our vision, mission, and culture underpin everything we do. Turning Point’s vision is to be the leader in precision oncology. Our mission is to bring differentiated therapies to patients with cancer as rapidly as possible. Turning Point’s culture unifies our team and is rooted in four core values:

  • Human Centric. Our work revolves around the patients we aim to serve, as well as the team members we innovate alongside. We relentlessly pursue new therapies, all with the intent to improve the lives of people with cancer.
  • Speed Where it Matters. We make decisions thoughtfully and quickly without sacrificing quality or integrity. Our team works with a sense of urgency to achieve its goals. We are dynamic with a purpose.
  • Extreme Team. We build strong relationships based on transparency and open communication. Determined but humble, we combine hard work and fun to achieve the extraordinary.
  • Resilience. Adaptive and nimble, we boldly embrace and drive change to continually evolve. We are continuous learners, recognizing challenges as opportunities to creatively solve problems.

The opportunity:

The Senior Director of Regulatory Affairs CMC is responsible for leading the Company’s Regulatory CMC function to enable clinical development, marketing authorization, manufacture and distribution of clinical supplies and commercial products. They will provide the organization with the strategic and operational leadership required to ensure Regulatory CMC compliance with global (both US and ex-US) regulations and submission requirement for clinical studies and commercial supply.

This Regulatory Affairs CMC leader is responsible for strategy decisions and risk mitigations for regulatory submission issues related to CMC. They will ensure effective collaborations and partnership with Quality and technical functions within the Company, as well as external partners and suppliers. They will also support the growth of the organization towards commercialization of Repotrectinib.

What will you do?

  • Responsible for the coordination, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, DMFs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submissions and marketing applications to the FDA, and if required international regulatory authorities), and ensure appropriate follow-up correspondence.
  • Lead the hands-on preparation and coordination in preparation and authorship of regulatory documents in CMC.
  • Coordinate and lead the task of drafting responses to CMC related questions from FDA or foreign health authorities.
  • Work with functional groups to provide timely responses to CMC questions from regulatory authorities.
  • Provide regulatory CMC expertise during due diligence.
  • Coordinate activities for meetings with FDA and other regulatory authorities, leads negotiations and interactions with regulatory authorities.
  • Interpret and communicate regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) to execute program objectives in compliance with applicable regulations.
  • Maintain current knowledge of regulations and guidelines (FDA, ICH and other as required).
  • Define global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.
  • Communicate CMC regulatory strategy, key issues and remediation activities needed throughout project/product life cycle to project team and appropriate management levels within and outside of Regulatory CMC.
  • Develop productive working relationships with other employees

We’d love to hear from you if:

  • You have a Bachelor’s degree in a scientific field or equivalent.
  • You have a minimum of 15+ years’ experience in regulatory CMC.
  • You have deep expertise and understanding of the CMC disciplines, technical development and manufacturing, quality and supply chain and experience working on CMC Teams.
  • You have proven ability to prepare and submit documents to FDA and globally, such as, Investigational New Drug (INDs), and New Drug Applications, (NDAs ), Marketing Authorizations Application (MAA), Clinical Trial Application (CTA) or Investigational Medical Product Dossier (IMPDs).
  • You have direct experience working with FDA and other international HAs, with confidence and persuasion to meet desired outcomes locally and nationally.
  • You have solid experience and knowledge of US regulations and ICH Q guidance, principles, concepts, industry practices and standards.
  • You have deep expertise and understanding of the CMC disciplines, technical development and manufacturing, quality and supply chain and experience working on CMC Teams.
  • You have international CMC regulatory knowledge and experience.
  • You have demonstrated experience leading and driving successful regulatory submissions, with first-hand knowledge of and experience interacting with FDA and European authorities at centralized or national level.
  • You have excellent regulatory writing skills and ability to critically review regulatory documents.
  • You possess excellent interpersonal skills with ability to lead effectively.

Benefits with you in mind:

Turning Point cares about each team member and their wellbeing. We take great pride in cultivating an outstanding employee experience where team members thrive and do their best work. For full-time employees, we offer competitive salaries, bonuses, and equity incentives. Full-time employees also enjoy competitive benefit options, including medical, dental, vision, disability, and life insurance. We also offer full-time team members an HSA with a generous employer contribution, as well as healthcare and dependent care FSAs. Turning Point supports employee retirement goals with a group 401K plan that includes an excellent company match. We know that time with family and personal time to recharge is important, and that’s why we offer full-time employees paid company holidays, a winter holiday season shutdown, vacation, and sick time. Full-time employees also have generous leave programs, employee referral bonuses and onsite perks such as a subsidized lunch delivery service, gym access, and a stocked kitchen made available during office hours.

We’re better together:

At Turning Point, we are committed to maintaining a diverse and inclusive working environment. When we say ‘diverse,’ we mean it in all senses of the word: not only in race, gender, ethnicity, age and orientation, but also in our interests, drivers and passion points. We believe our individual differences and perspectives are what make us stronger as a team and unite us in our purpose. Our hybrid work environment provides flexibility for individuals and empowers teams to collaborate and build relationships in meaningful ways. We safeguard equal rights and respect for all individuals, regardless of race, color, religion, sex, national origin, age, disability, creed, genetic information, sexual orientation, gender identity or expression, ancestry, veteran status, or other applicable, legally protected characteristics.

Learn more here

Job posted: 2022-07-10