Parsippany, NJ 07054
- Acts as the Regulatory Affairs representative on assigned projects; Leads regulatory interactions with and presentations to Regulatory Health Authorities, customers and partners; provides current regulatory information and guidance to project teams on a proactive basis.
- Develops regulatory strategies and identifies and implements appropriate submission strategies for assigned projects; provides input for product labeling, advertisement and promotion, and clinical projects. Responsible for establishing strategies for document authoring, contributing strategically and scientifically at the project and/or study team level, managing vendors and external writers with regards to document quality, and developing regulatory writing timelines, processes, and working standards.
- Develops submission plans and provides project management preparation of submission dossiers to US and international health agencies in the areas of new drug development and approved product support. This includes IND/CTA applications, NDA/MAA applications, annual reports, investigator brochures, clinical reports, and meeting requests/briefing packages, and others.
- Ensures regulatory submissions are of high quality and submitted in a timely manner; reviews regulatory filings for accuracy, completeness, and compliance with applicable regulatory requirements and internal procedures.
- Independently develops regulatory documents for regulatory submission such as eCTD module 2 summaries, health authority meeting briefing documents, and other regulatory documents as needed.
- Ensures key messages are clear and consistent within and across documents.
- Contributes strategically and scientifically at the project team level.
- Contributes to formation of key messages in consultation with functional area experts.
- Advises project and study teams regarding regulatory requirements and ICH guidance for clinical documents.
- Reviews and approves Study Protocols, Clinical Study Reports, Statistical Analysis Plans, ISS and product labeling.
- Ensures fulfillment of commitments made to various health agencies (e.G., IND/NDA/MAA pediatric and post-marketing commitments, and others).
- Manages vendors and external writers with regards to document quality; provides guidance to external writers on company standards and style and industry best practices for regulatory writing.
- Contributes interdepartmentally to Clinical/Medical, Drug Safety, and R&D departments as needed.
- Demonstrated strong understanding of the U.S. And EU Regulatory requirements.
- Proven ability to interpret and apply regulations to specific projects (FDA and ICH or other regulatory agency guidance requirements).
- Excellent written and verbal English communication skills
- Demonstrated excellent organizational skills
- Proven negotiation skills.
- Proven ability to manage multiple projects, set priorities and meet deadlines.
- Excellent skill level in MS Office including Word, Excel and Outlook.
- This position requires approximately 10-15% travel with overnight stays.
- Bachelor s degree in life science from an accredited college or university.
- Minimum 8 years progressively responsible experience in Regulatory Affairs in the U.S. Pharmaceutical industry.
- Knowledge of clinical development required; knowledge of nonclinical, clinical pharmacology, biostatistics and CMC regulatory desirable.