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Director/Senior Director, Regulatory Affairs – CMC

Location: Philadelphia, PA

Job Description

JOB TITLE

Director/Senior Director, Regulatory Affairs – CMC

 

REPORTS TO

Vice President, Head of Regulatory Affairs

 

POSITION SUMMARY

Tavanta Therapeutics is a clinical stage biotechnology company developing a diverse pipeline of drugs that bring clinically meaningful benefits to patients with serious or debilitating diseases.  As we continue to grow and expand, there exists an immediate opportunity for a Regulatory Affairs CMC experienced professional to join our Team.  Reporting to the Vice President, Head of Regulatory Affairs, the incumbent will be responsible for leading the development and implementation of global CMC regulatory strategies and authoring scientific and regulatory documents necessary for Global Health Authority submissions and approvals.

The corporate culture at Tavanta is grounded in the core values of accountability, teamwork, and support. It is the responsibility of every person to emulate and abide by these values as the company continues to grow.

  • We are all accountable for efficient and effective development of products that help patients with unmet medical needs through focus on innovative strategies and operational excellence
  • We value teamwork and work in high-performing teams whose success is based on trust, transparency and integrity
  • We challenge each other. We motivate each other. We support each other.

 

Essential Duties and Responsibilities

  • Be a key contributing member working directly with Regulatory leadership and functional teams across Tavanta to develop global CMC strategies supporting the successful regulatory development, registration, and commercial launch of products.
  • This is a highly visible role within the organization and the incumbent must be solution-oriented in their approach to global regulatory and development challenges for CMC.
  • Plan, prepare, and review submissions to Health Authorities to support the conduct of clinical trials and approval of new drug and marketing applications with a focus on CMC.

Qualifications

Knowledge, Skills and Behaviors

Education and Experience

  • Master’s degree and at least 10 years of experience working in a regulatory CMC capacity in the biotechnology or pharmaceutical industry, or an equivalent combination of education and experience required; PhD preferred.

 

 

  • Prior experience in a Regulatory CMC leadership role with design and implementation of IND, NDA and regulatory submissions is required. This experience could be obtained through prior work in the pharmaceutical, biotechnology industry and/or clinical research organizations.
  • A thorough understanding and working knowledge of the current FDA and EMA regulatory environments and guidance/guidelines CMC requirements (including ICH), as they relate to the development of new molecular entities and currently approved drug products for IND/CTA, and NDA regulatory submission pathways [505(b)(1) and 505(b)(2)].
  • Demonstrated track record of leading CMC strategies for meetings and interactions with the FDA and global Health Authorities.
  • Experience working in small, fast moving development organizations.
  • Drug-device combination experience desired.

 

Skills and Behaviors

Required skills and behaviors

  • Excellent verbal and writing skills with the ability to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
  • Demonstrated ability to think creatively and efficiently, work within a small team environment with both internal and external stakeholders and collaborate effectively in a time-efficient manner.
  • Strong negotiating skills with a creative solution-oriented focus.
  • Actively participate and present to all levels of management across the organization.
  • Ability to be a team player and operate with high integrity.
  • Highly organized and able to work on his/her own with limited oversight
  • Collaborative, creative, and open-minded, and eager to help others

 

Work Environment

  • This position will be based in the King of Prussia, PA headquarters with the possibility of up to 10% domestic and global travel. There is much flexibility to work from office and home and a minimum requirement to visit the office once or twice a month.
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