Director, Regulatory Affairs - Pharma
- Contract Type
Scope of Responsibilities:
The Director of Regulatory Affairs is responsible for directing, planning, and implementing all regulatory operations for products, line extensions, licensed products etc. This includes regulatory strategies for new product registration and submission of appropriate regulatory filings. In terms of Regulatory Planning and Development, the Director of Regulatory Affairs adds a vast knowledge of the interpretation of rulings, policies, guidelines and regulations of the FDA, EMA, and other agencies as they relate to our products and practices.
The Director of Regulatory Affairs advises on CMC topics to include but not limited to process validation, verification and assists technical transfer projects.
In terms of Regulatory Compliance, The Director ensures post-marketing regulatory compliance, including compliance with adverse event reporting requirements, and as such will assist in the preparation of submissions and the monitoring of applications submitted to the FDA and other agencies, including overseeing, preparing and submitting annual reports. The Director leads staff training and makes sure that everyone is versed on the regulatory compliance. If necessary the Director will facilitate
recalls, safety alerts, or notices of failure to comply with regulations as well as liaising with Global Quality regarding crisis management and the development of correction action plans in response to 483's, warning letters and administrative actions.
The Director of Regulatory Affairs is responsible for, but not limited to, the following:
• Ensure all aspects of regulatory affairs are properly planned and formulated and executed according to FDA and other agency regulatory requirements.
• Works with the rest of the business team to prepare product development strategies leading to product labeling and promotional positioning. Plus, Artwork creation activities.
• Responsible for leading assigned RA projects and teams by ensuring all activities are on target.
• Responsible for reporting ALL submissions to FDA and other agencies
• Ensures timely preparation or organized and valid submissions for business and regulatory review.
• A minimum of a MS in pharmaceutical, science or related field
• Minimum of 10+ years of recent experience in the pharmaceutical regulatory business with emphasis on multiple aspects of FDA and EU laws and regulations. Experience in late phase, life cycle management and CMC preparation and documentation and proven success in regulatory submissions in the pharmaceutical industry.
• Strategic thinker, planner, and implementer. Excellent organizational skills. Hands on approach and working to tight deadlines
• Excellent communication skills, knows how to present data/issues both to a technical and non-technical audience with the ability to write and edit regulatory documents
• Able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes.
• Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables.
• Demonstrates potential for a high level of collaboration with others and independent thought.
• MS Office skills with excellent use of excel, PowerPoint and MS Project required.
• Must have sound knowledge of such principles as GMP's, FDA guidelines,
• CRO management experience preferred.
• Recent experience with a smaller entrepreneurial environment is a definite asset
• Excellent knowledge of GxP compliance issues.
• Excellent interpersonal skills and fluent in English (written and oral)