Associate Director, Regulatory Affairs
Kevin P. Malobisky, Ph.D., M.S., RAC
Chief Regulatory and Strategic Operations Officer
Tavanta Therapeutics is a clinical stage specialty pharmaceutical 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 professional to join our Team. Reporting to the Chief Regulatory and Strategic Operations Officer, the incumbent will be responsible for leading the development and implementation of global regulatory strategies across multiple research and development programs and participating in the ongoing development and implementation of the Quality Management System (QMS) at Tavanta.
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
- The Associate Director, Regulatory Affairs will work directly with leadership to develop global efficient 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
Responsibilities will include:
- Understanding the current U.S. and E.U regulatory environments and developing strategies to support the development of new molecular entities and currently approved drug products utilizing the 505(b)(1) and 505(b)(2) regulatory pathways
- Leading the development, authoring, and overseeing publishing and submission operations for briefing documents, responses to questions from regulatory authorities, INDs, and NDAs, and other documents (e.g., orphan drug applications, DSURs, etc)
- Participating in global project team meetings by providing regulatory guidance and expertise
- Conducting and providing regulatory research and intelligence for development programs, new indications, and label expansions
- Actively participate and present to all levels of management across the organization
- Develop and manage project and department forecasting, budgeting, and spend
- Identify and collaborate with external subject matter experts, consultants, and vendors to drive projects forward in alignment with corporate goals and values
Partner with Quality Team in the development and implementation of the Quality Management System
Knowledge, Skills and Behaviors
Education and Experience
The candidate will have a Bachelor of Science in a scientific discipline; Master of Science preferred; Regulatory Affairs Certification a plus but not required. In addition, the candidate should have a minimum of 7 years direct experience working within a small biotechnology and/or specialty pharmaceutical organization.
The successful candidate will also have:
- A thorough understanding and working knowledge of both FDA and ICH Regulatory requirements for pharmaceutical drug development including a strong, demonstrated understanding of GxPs
- A demonstrated track record of leading regulatory strategies in a matrix organization, including meetings and interactions with the FDA
- A 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
- Cultural awareness working with team, vendors, and stakeholders across countries
- Strong oral, written, presentation, and negotiation skills required
Skills and Behaviors
The Associate Director, Regulatory Affairs must be an enabler and educator to internal and external teams and stakeholders.
Required skills and behaviors include:
- Team oriented and goal-driven while being self-aware of strengths and weaknesses
- Highly organized and able to work on his/her own with limited oversight
- Collaborative, creative, and open-minded, and eager to help others
- Persistent and optimistic about overcoming obstacles and uncertainty
- Flexible and willing to try/learn new things and approaches
This position will be in the Philadelphia, PA headquarters location with the possibility of up to 25% domestic and global travel