The Director of Regulatory Affairs is responsible for directing all regulatory activities during preclinical development, IND filing and review, clinical development, NDA filing and review, as well as the post-development stage, as applicable. This individual will be responsible for planning, developing and implementing regulatory policies and strategies for earliest possible approvals of Phase I through IV applications in support of corporate goals. He/she will manage all regulatory activities and serve as the main contact with the FDA and other regulatory agencies, as well as business partners, on development projects. The Director of Regulatory Affairs will review and prepare responses to inquiries from regulatory authorities relating to product registrations, and provide counsel to and direct the regulatory team.
RESPONSIBILITIES:
The Director of Regulatory Affairs is responsible for ensuring timely preparation and submission of regulatory documents, including INDs, NDAs, and international equivalents. He/she will stay abreast of regulatory requirements to provide expertise in translating regulatory requirements into practical, workable plans and review labeling, manufacturing, preclinical and clinical documents for regulatory compliance.
SPECIFIC DUTIES:
Regulatory Affairs
• Manages all regulatory activities for assigned projects, including representation on the project development team. Interacts with key members of the preclinical, toxicology, CMC, QA/QC and clinical teams by providing guidance and feedback to the team. Maintains awareness and communication with team members regarding changing FDA requirements for effective submissions
• Overall responsibility for the planning, preparation, coordination and submission of pre-IND packages, original INDs and NDAs, safety reports, and responses to FDA queries, as well as maintaining active INDs (Annual Reports, supplements, etc.)
• Assures the company complies with Chapter 21 CFR and all relevant ICH guidelines as stipulated by the FDA or other regulatory agencies, and with current GLP, GMP, and GCP guidelines. Maintains IND and NDA submission documentation system and database tracking of all interactions
• Interacts with Clinical and Corporate Communications to review company's public statements (press releases, scientific information, publications, website, etc.) with regard to regulatory compliance
• Functions as primary contact for negotiations and interactions with domestic and foreign regulatory agencies
• Communicates with regulatory agencies in writing and by phone and in face-to-face meetings; ensures the timely preparation of scientifically valid submissions
Strategic Planning
• Interacts internally and externally with senior management and executive levels; advises on matters concerning regulatory affairs
• Identifies and evaluates fundamental strategies and tasks, problems and their potential resolution and all other relevant matters concerning regulatory affairs and strategies for IND and NDA filings
• Oversees regulatory strategies and planning with business partners on development projects, offers regulatory advice to multi-disciplinary project teams; establishes timelines and reviews preclinical and clinical protocols and reports
• Provides regular status updates and progress reports to senior management and track competitors' drug filing activities, Advisory Committee actions and approvals
Departmental Activities
• Sets timelines, budgets, schedules and performance metrics for regulatory team and ensure these requirements are met
• Provides training and career development for regulatory personnel
• Responsible for establishing and maintaining regulatory SOPs
• Provides regular in-house training to relevant staff on Regulatory Affairs updates related to clinical development
REQUIREMENTS:
The strongest candidate will be a dynamic individual with experience in setting regulatory policies and strategies for earliest possible approvals of Phase I through IV applications in a biopharmaceutical company setting. This individual should have a strong knowledge of regulations/guidelines governing development of pharmaceuticals. The person will have a strategic orientation while ensuring that all details are managed efficiently. Successful candidates will have the self-confidence and skills to not only gain the respect of, but to lead and influence a highly educated and talented workforce. The best candidates will also have a passion for the mission of the company and the role that the regulatory department plays in driving the success of the business.
ADDITIONAL REQUIREMENTS:
• Advanced degree (BS/MS/PhD) in scientific/life-sciences discipline or related field
• Minimum 8 years of pharmaceutical or biopharmaceutical industry experience and 5+ years direct regulatory affairs experience and key management
• A solid working knowledge of all aspects of Regulatory Affairs, including Clinical, Preclinical, CMC, Labeling, and Advertising
• In-depth knowledge of CDER (Infectious Disease, Inflammation and Oncology Divisions) guidelines and an intimate knowledge of European regulations a strong plus
• Certification as a Regulatory Affairs Professional desirable
• Adherence to applicable FDA/ICH guidelines regarding clinical trials, regulatory documents and safety issues
• Excellent organization and management skills and ability to exhibit initiative and to work independently
• Ability to establish relationships with thought leaders to provide assistance to identify critical path to goal completion
• Excellent writing skills to apply regulatory requirements and standards for documentation requirements, including the ability to effectively describe complex situations
• Excellent evaluation, analysis and interpretation skills to review reports and other documents used in regulatory planning and submissions
• Excellent interpersonal skills and coordinating experience
• Computer experience with MS Word, Excel, Access, email and project management software, as a minimum
