Job Title: Director, Regulatory Affairs
Department: Pharmaceutical Development
Job Summary:
The Director, Regulatory Affairs develops, implements, leads and supports regulatory strategies for assigned projects in collaboration with various cross-functional teams. The Director, Regulatory Affairs will execute developed strategies for earliest possible approvals of the company's regulatory applications at all stages of product development and post approval activities. They will facilitate publishing activities with internal and external stakeholders including authoring cover letters forms, eCTD sections and preparing documents for submission to regulatory agencies, as well as ensuring that they meet current regulatory requirements and industry standards, are high quality, consistent, and complete.
Essential Duties & Responsibilities:
Content Management
- Responsible for content management and integration of content assembled from cross-functional subject matter experts to support document finalization and publishing.
Project Management
- Ability to develop and execute regulatory strategies for drug development, registration, and post-marketing activities.
- Assist with the planning, coordination and management of internal regulatory preparatory meetings and the preparation of staff members participating in these meetings that will support formal regulatory interactions.
- Leads the Regulatory Affairs functional responsibilities in Change Management Activities.
- Assures regulatory compliance with safety reporting, IND/NDA updates and accessibility to historic documentation required to maintain compliant activities across the organization.
- Serves as the primary contact for all interactions with regulatory agencies such as the FDA.
Regulatory Submissions
- Oversee document publishing and management of publishing vendor for regulatory submissions.
- Responsible for supporting the creation and management of submission plans and ensure coordination of development/commercial activities with the submission processes to drive agreed-upon timelines.
Process Improvement
- Identify process improvement for internal systems and processes related to publications, submissions and archiving of regulatory records.
Other
- Monitor and assess changes in regulatory requirements, guidelines, and legislation, and provide guidance to internal stakeholders on potential implications and opportunities for the business.
- Complete other duties as assigned
Experience & Qualifications:
- MS or advanced level degree in either chemistry, biological or biomedical related fields.
- 10+ years demonstrated experience in drug regulatory affairs in the pharmaceutical or biotech industry.
- In depth knowledge of FDA regulatory requirements with hands on experience interacting directly with the Food and Drug Administration.
- Experience with the Dermatology and Dental Product Division and/or the Division of Anti-Infectives of the FDA and other regulatory regions and agencies would be an asset including understanding of other medicinal products such as medical device requirements.
- Ability to think strategically, operationally and tactically to bring regulatory insight to pre-approval and post-approval activities.
- Experience in guiding an organization around filing strategies.
- Demonstrated background in coordinating across disciplines to ensure timely filings.
- Hands-on experience with INDs, and NDAs filing requirements.
- Ability to work collaboratively as the regulatory affairs business partner to local development and commercialization teams.
- Sound judgement and ability to analyze situations and information. Makes decisions based on facts and figures rather than on assumptions.
- Ability to develop an in-depth understanding of milestones and associated implementation timelines for regulatory interactions, strategies, and key decisions points to support existing and future development activities.
- Strong organization and planning skills.
Physical & Environmental Requirements:
The essential functions of this position include:
- Lift up to 25lbs on an occasional basis
- Stand, walk and sit on a frequent basis
- Stoop, kneel, crouch or crawl on an occasional basis
- Reach, hands and arms on an occasional basis
- Use hands to feel on an occasional basis
- Communicate using hearing and speech on a frequent basis (in-person and/or virtual)
- Use sense of smell and vision (color difference, depth perception) on an occasional basis
- Up to 10% of travel (more if not local to Durham, NC office)
These functions must be performed safely and effectively, without posing a direct threat to the employee or others, with or without reasonable accommodation.
