The Vice President of Regulatory Affairs provides leadership for regulatory strategy, oversees agency interactions and guides Regulatory Operations in the preparation, submission, and management of regulatory submissions for Novan’s advanced products in Dermatology and earlier stage products in other indications. The Vice President of Regulatory Affairs works in close collaboration with line management and the cross-functional subject matter experts to draft and align the content and message for regulatory submissions for nonclinical, clinical, CMC, and the appropriate reporting of safety, as required by regulatory health authorities. The individual ensures data and other documentation presented in all submissions are presented concisely, in full, and that data supports the conclusions and addresses the associated risks. The individual is responsible for establishing Regulatory Affairs standards for a process consistent with Novan’s technology systems and department infrastructure. The Vice President of Regulatory Affairs shall adhere to the Company’s quality system including but not limited to the applicable standards, policies, and procedures in the areas of responsibility defined in this job description.
Principal Responsibilities and Accountabilities:
Participate as the leader of Regulatory Affairs across all company programs to provide regulatory strategy in all relevant areas including nonclinical, clinical, pharmacovigilance and CMC, inclusive of the medical device.
Participate in product strategy team meetings to provide advice and direction, including identifying and assessing regulatory risks and providing regulatory tactics to meet requirements.
Lead all formal regulatory reviews/ meetings. Champion effective communications and interactions with regulatory health authorities
Author regulatory vital messages and provide outlines for submission documents supporting Investigational New Drugs and New Drug Applications, US, and ExUS, meeting briefing packages and other regulatory documents/responses as required.
Oversee cross-functional submission content and the publication of regulatory submissions according to required due dates and under applicable regulations and guidelines. The individual provides advice on documents prepared by other departments to meet the requirements set forth by regulatory health authorities.
Represent Novan in regulatory discussions for partnered programs.
Complete final review (content, formatting, compilation) of all regulatory submissions, to ensure documents for submission are compliant with current regulations and guidance.
Provide a regulatory assessment of manufacturing processes and changes, determine the impact of changes on regulatory filings, and oversee the preparation of appropriate amendments and supplements.
Provide regulatory assessment for medical devices, determine the impact of changes on regulatory filings, and oversee the preparation of appropriate amendments and supplements.
Manage all interactions and direct communications with regulatory health authorities. Collaborate with subject matter experts to provide written responses to questions as appropriate.
Maintain awareness of the industry and regulatory developments and maintain training of Regulatory Affairs staff on new guidance requirements and submission regulations.
Drive preparation activities for inspection readiness within Regulatory Affairs to support regulatory audits and inspections.
Perform other duties as assigned.
Perform duties on site, on time, and within the Company’s regular business hours listed in the Employee Handbook. Facilitate frequent interactions with co-workers and conduct timely problem-solving meetings necessary to address critical and emerging work issues. Present a positive attitude to create and maintain productive working relationships with fellow employees and vendors.
Bachelor’s degree in life sciences or related field, with a professional degree, preferred
Regulatory Affairs Certification (RAC) required.
15+ years’ regulatory affairs experience
Experience in a biotech/pharmaceutical environment required.
Experience with medical device regulations preferred
Expertise in the FDA and ICH regulations and guidelines and knowledge of the drug development process.
Previous experience with eCTD regulatory submissions.
Supervisory experience required
Highly proficient in written, and verbal communication.
Strong interpersonal, problem solving and decision-making skills
Demonstrated ability to provide guidance and direction to others effectively.
Superior attention to detail; highly organized and process-oriented.
Self-motivated team player with a strong work ethic and ability to make decisions independently.
Strong project management skills and the ability to effectively lead individuals and cross-functional teams to complete projects and accomplish goals.
Effectively prioritize workload and manage time to complete multiple projects within established timelines and goals in a fast-paced environment.
Proficiency in Microsoft Office applications is required, specifically Microsoft Word, Excel, and PowerPoint, as well as Adobe. Experience with electronic document management systems is required.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e., typing) and occasional lifting up to 20 pounds.
Novan, Inc. maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.
Novan, Inc. is an equal opportunity employer and actively seeks candidates from diverse backgrounds including women, communities of color, the LGBT community, and people with disabilities.
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About Novan, Inc.
Novan is a clinical-stage drug development company focused on topical delivery of nitric oxide. The company's proprietary platform technology enables the stable storage and release of nitric oxide in a variety of dosage forms. Novan is currently developing innovative, first-in-class therapies for the field of dermatology.