Director/Assc Director, Regulatory Operations (Emerging Biotech) – Top $$/RTP, NC
Our client, a clinical stage biotechnology company that is focused on leveraging its proprietary technology to develop treatments for multiple indications in dermatology, men’s and women’s health, infectious diseases and others, is actively recruiting for a highly capable and knowledgeable candidate to drive Regulatory Operations.
This is a critical and impactful role for the company and compensation will be generous. If interested, please forward up-to-date resume or CV for prompt consideration.
Key Things to Note:
- This company is planning for three potential NDA filings with the first submission expected in Q3 2022. These are New Chemical Entities (NCE) and this Director/Assoc Director (client is open to both levels) would be coming in on the ground floor.
- The focus of the role will be to drive the development and coordination of high-quality regulatory submissions. Substantial knowledge of regulatory submission standards and practices must be complemented by exceptional Project Management skills.
- To date the company has used external consultants and SMEs to help guide regulatory strategy. This Director/AD will continue to involve consultants as needed and will direct all internal operations. Seek candidate who is accustomed to coordinating the work of multiple stakeholders.
- This Director/AD will be a primary contact for the FDA and other regulatory bodies. Experience communicating with regulatory or other government entities will be important.
- This is an emerging business setting with a “start-up” vibe. Seek candidate who enjoys the building process and will be instrumental in developing and implementing standard operating procedures. Experience developing/enhancing document management systems would be a plus.
- This D/AD will be on-site at the company’s RTP area offices 1-2 days/week. Seek NC area candidates only.
Position will involve :
- working closely with leadership and cross-functional SMEs to support content compilation and finalization, ensure alignment of messaging and oversee submission of final documents
- leading the organization of and participation in meetings with regulatory agencies, ensuring documentation of discussions, and driving the follow up for resulting regulatory actions
- overseeing effective and appropriate archival management of regulatory documentation
Selected responsibilities will include
- Drive content management and integration of content assembled from cross-functional SMEs to support document finalization
- Plan, coordinate and manage internal preparatory meetings in support of formal regulatory reviews/meetings
- Create and manage submission plans and ensure coordination of development activities with the submission processes to drive timelines
- Manage publishing vendors for all regulatory submissions
- Oversee document publishing for regulatory submissions
- Oversee management and archival of regulatory records
- Identify process improvements for internal systems and processes related to publications, submissions and archiving of regulatory documents
- Maintain awareness of the industry and regulatory developments and support training opportunities to Regulatory Affairs staff on new guidance requirements and submission regulations.
Targeted candidate will offer a BS degree in related science and 10+ years in a biotech/pharma environment, including substantial exposure to Regulatory Affairs matters. RAC certification and emerging/start-up company experience both preferred.
Other priorities include:
- Demonstrated knowledge of FDA and ICH regulations, guidelines for New Drugs and Medical Devices, knowledge of the drug development process and experiences in IND and NDA regulatory submissions
- Experience in analyzing and developing strategies for clinical development, regulatory submissions, and compliance issues
- Ability to liaise, negotiate and interact with FDA and worldwide regulatory agencies
- Exceptional Project Management skills including ability to effectively coordinate the work of multiple, cross-functional stakeholders in a fast-paced, highly dynamic setting.
- Experience in managing, developing, organizing, and maintaining controlled and noncontrolled files
- History of growth, impact and longevity
Finally, we seek a highly capable and mission-driven candidate who demonstrates the ability to overcome barriers, work through the ambiguous and earn the respect and cooperation of others in order to achieve shared success.
There is a lot happening and the future is bright. We seek a leader who is ready and eager to contribute.