Director/Associate Director, Regulatory Affairs (Oncology) - NC Biotech/Will Relo
Our client, a NC-based biotechnology company focused on the development and commercialization of groundbreaking immunotherapies to treat for a wide range of cancers, is actively recruiting for an exceeding capable and knowledgeable candidate to assume key role on its Regulatory Affairs team.
This is a critical time in the company’s growth and ensuring the right people are in place to lead its Regulatory efforts is essential. Company will pay industry-leading wage (including relo) to attract and retain the right candidate.
Key Things to Note:
- The company has multiple products in development and a growing pipeline (early development into Phase 2). The future is very bright.
- This Director/AD (company is open to either level) will work with leadership to develop Regulatory Strategy and then be responsible for execution of regulatory operations and regulatory compliance activities. Right candidate will be a thoughtful and knowledgeable strategist as well as a skilled tactician.
- This Director/AD will be a key Subject Matter Expert (SME) for the company and involved with all aspects of Regulatory including submissions, strategy, operations and compliance. Seek broadly-skilled Regulatory professional. Oncology bkgd would be a plus but is not a must.
- This is a SME, non-supervisory role. This D/AD will work with cross-functional teams, including overseeing work done by external consultants, but does not have direct reports at this time.
- This position will begin as remote but post-pandemic will require a Raleigh-Durham area presence. Company will relocate top candidate.
- Manages the regulatory operations activities for company programs
- Collaborates with Head of Regulatory Affairs and other company stakeholders to provide input on the development and implementation of the regulatory strategy for all company programs
- Oversees IND maintenance activities, including tracking, document development, publishing, and submission activities for company programs
- Assesses and monitors company regulatory compliance with SOPs, study protocols, industry standards, and regulatory requirements
- Manages external vendors to support regulatory operations activities, as needed
- Assists QA and other staff with regulatory agency inspections and audit activities, as needed
- Provides training and support to cross-functional team members, as needed
Targeted candidate will offer a related scientific degree (advanced degree preferred) and 5+ years of Regulatory Affairs experience. Regulatory Affairs Certification is strongly preferred.
Other priorities include:
- Strong knowledge of US FDA regulations, ICH guidelines, and GXPs and their application to regulatory submissions (global regulatory experience is a plus)
- Successful IND submissions management experience
- Excellent organizational and project management skills
- Experience with publishing software for regulatory submissions
- Longevity, impact and growth in previous roles
Finally and critically, we seek a candidate who will thrive in this emerging business setting. This company has created a highly empowered, collaborative and mission-driven culture. Seek proactive, resourceful and can-do candidate who is ready and eager to contribute.
Please forward Word resume for prompt consideration. Compensation will be generous.