Novan
  • 04-Dec-2017 to 04-Feb-2018 (CST)
  • Morrisville, NC, USA
  • Full Time

Purpose:

The Associate Director of Regulatory Affairs will work in close collaboration with line management and cross-functional project teams to develop and implement regulatory strategies and coordinate regulatory submissions, including nonclinical, clinical, and CMC. Working with internal scientific and technical departments as well as external vendors, the Regulatory Affairs Manager will be responsible for the preparation and submission of regulatory documents, management of submission processes, and oversight of various regulatory tracking tools, timelines and infrastructure. In addition, this role will provide strategic regulatory guidance to all departments and project teams. The Regulatory Affairs Manager 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:

  1. Participate as Regulatory Affairs representative on assigned projects, and assist R&D teams by providing strategic regulatory guidance and information across all relevant areas including nonclinical, clinical, and CMC.
  2. Oversee and manage regulatory operations; collaborate with project teams to author and publish regulatory submissions, including formatting and compilation of paper and electronic submission documentation, and file by required due dates and in accordance with applicable regulations and guidelines.
  3. Author documents for submission, including regulatory agency correspondence, documents for INDs and NDAs, and meeting briefing packages, and review and provide regulatory comments and advice for documents prepared by other departments.
  4. Ensure documents for submission are in compliance with current regulations and guidance.
  5. Provide regulatory assessment of manufacturing processes and changes, determine impact of changes on regulatory filings, and prepare appropriate IND amendments and NDA supplements.
  6. Manage and track regulatory queries from regulatory agencies and collaborate with subject matter experts to provide written responses to questions.
  7. Contribute to the review, implementation, and maintenance of the submission process and provide creative and innovative solutions for ongoing process improvement while maintaining compliance.
  8. Prepare for and participate in regulatory audits and inspections.
  9. Maintain awareness of industry and regulatory developments and provide updates to regulatory and project teams.
  10. Perform other duties as assigned. Perform duties on site, on time, and within the Company's normal 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.

 

Qualifications:

  1. Education
    1. Bachelor's degree in life sciences or related field.
    2. Regulatory Affairs Certification (RAC) preferred.
  2. Experience
    1. 10+ years' regulatory affairs experience.
    2. Experience in a biotech/pharmaceutical environment required.
    3. A thorough understanding of FDA and ICH regulations and guidelines and knowledge of the drug development process.
    4. Previous experience with eCTD regulatory submissions.
    5. Supervisory experience preferred.
  3. Skills
    1. Superior attention to detail; highly organized and process-oriented.
    2. Self-motivated team player with a strong work ethic and ability to make decisions independently.
    3. Strong project management skills and the ability to effectively lead individuals and cross-functional teams to complete projects and accomplish goals.
    4. Strong interpersonal, problem solving and decision-making skills.
    5. Highly proficient in written, and verbal communication.
    6. Demonstrated ability to provide guidance and direction to others effectively.
    7. Effectively prioritize workload and manage time to complete multiple projects within established timelines and goals in a fast-paced environment.
    8. Proficiency in Microsoft Office applications is required, specifically Microsoft Word, Excel, and PowerPoint, as well as Adobe. Experience with electronic document management systems is preferred.

 

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 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 does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.

Novan
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