Associate Director Regulatory Affairs
Provides global regulatory intelligence expertise to regulatory affairs, pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures that regulatory/competitive intelligence, or scientific/regulatory information searching, summarization, assessment and dissemination are provided to the Otsuka organization.
Proactively monitors emerging external scientific and regulatory trends, approvals, and strategies to inform and influence the development of regulatory strategies and policies both across and within disease therapy areas. Works with Global Regulatory Management to provide both routine and ad hoc requested information including implementing a commenting process on health authority guidance and directives.
Leads development of Policy or Position Papers.
- Under the direction of the Senior Director Global Regulatory Affairs, provides strategic regulatory intelligence using both routine reports and as well as targeted information to support both project and organizational activities.
- Designs programs for complete and accurate IND/CTA/NDA submissions and ensures that clinical trials are designed to meet regulatory requirements.
- Takes independent and creative actions to determine solutions to meet the known and anticipated needs for the organization at both the product and organizational levels.
- Independently compiles regulatory and competitive intelligence and ensures good channels of communication are established for this information.
- Interacts with providers of regulatory and competitive intelligence to ensure high quality sources of information.
- Identifies and oversees outsourced suppliers of regulatory intelligence and assessments in the preparation and documents/reports.
- Work closely with IRC as search and information resource.
- Develops and implements a health authority guidance and directive commenting process.
- In collaboration with Regulatory leadership, develops and implements regulatory information tools and reporting methods.
- Investigates and analyzes the regulatory precedence for Health Authority approvals for competitive products.
- Identifies the development programs used to support competitors' license applications and the issues raised during the review process, including scientific advice and results of FDA Advisory Committee meetings.
- Prepares and delivers regulatory intelligence newsletters on agreed schedule highlighting pertinent regulatory activities and potential impact on Otsuka Business and products.
- Supports Regulatory Policy initiatives through the delivery of research and analysis.
- Works with other functional areas including Technical Operations, Supply Chain, Commercial, Quality, Clinical, Nonclinical etc. to develop solutions for need for regulatory intelligence (e.g. manufacturing monitoring supplier report) for GMPs status, recalls, warnings etc.
- Develops strong relationships with Regulatory Policy, government affairs and commercial competitive intelligence groups within Otsuka through membership in cross functional task forces and projects.
- Works with regulatory strategists to support the development of strategies, health authority and other materials to support development and post marketing.
- Identifies early all major regulatory issues and ensures these are communicated to relevant stakeholders in a timely manner.
- Responsible for leading / facilitating global review for health authority and trade association guidance’s and position papers and submitting high-level of quality final comments within timeframe allotted.
- May serve as part of Clinical Regulatory and labeling teams as needed.
- Trains and coaches internal and outsourced staff on regulatory intelligence sources and reporting methods.
Supports or leads projects and non-project activities e.g. SOP/standards development, organizational initiatives, as needed. etc.
- Comprehensive knowledge of the regulatory affairs intelligence and competitive drug, device, diagnostics databases and sources/environment.
- Hands-on experience and good understanding of the development and regulatory processes.
- Proven success of delivering easily consumable and comprehensive information materials as presentation or documents.
- A background in the regulatory intelligence community and connections within the industry and related organizations.
- Strong information searching, summarization and assessment skills.
- Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
- Strong analytical skills and problem solving ability.
- Strong communication and presentation skills.
Associate Director - Bachelor's degreerequired, advanced preferred (PharmD, MLS, PhD, MD etc.) with a minimum of 15 years of experience in regulatory intelligence, regulatory affairs, and/or scientific/regulatory information searching, summarization, assessment and dissemination