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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
The Senior Director of Regulatory Affairs is a leadership position with focused responsibilities on new drug submissions and compliance for the Clinical, Drug Safety, Advertising & Promotion and Labeling aspects of drug development for the company’s technology platform and pipeline.
This individual will lead the development of global regulatory strategies, review data packages for product candidates to ensure high quality and valid data in support of regulatory applications, and ensure that data submitted in response to regulatory agency requests adequately addresses concerns and are submitted in a timely fashion, meeting highest quality standards.
This position serves as a key liaison with the FDA, with responsibility for global regulatory submissions.
The Senior Director will be responsible for providing strategic regulatory advice and oversight of labeling, advertising and promotional materials and external communications for marketed and investigational products.
This role will serve as the lead regulatory affairs representative on the promotional materials review committee.
Develop regulatory strategies from development through product lifecycle management to achieve successful global regulatory clinical and marketing applications that enable optimal product claims and business objectives.
Oversee or execute timely and accurate submission of investigational and marketed product applications, amendments and supplements, including promotional materials to OPDP
Review and approve applications versus appropriate guidelines and regulations.
Provide strategic input and technical guidance on regulatory requirements to R&D and Commercial teams.
Act as recognized expert to internal work teams, external regulatory authorities and other regulatory affairs professionals.
Establish and implement innovative vision and strategies for achieving successful and compliant communications for commercially available products and investigational products
Provide regulatory leadership, including strategy and guidance and work directly with the stakeholders (such as Commercial, Medical Affairs and Legal) from concept through review and approval of labeling, promotional materials and activities, ensuring compliance with corporate policies, federal regulations and guidelines, and product development objectives
Ensure that changes in US Package Insert are appropriately implemented and reflected in current promotions and advertising
Develop and design best-in-class regulatory processes and procedures based on expert understanding, industry experience, and insight into future direction.
Clearly and efficiently analyze issues and communicate options in the face of ambiguity with a willingness to collaborate and problem solve
Over time, effectively plan for, build, maintain and motivate a team
15+ years pharmaceutical/biotechnology industry experience with management experience.
Minimum 10 years in Regulatory Affairs with proven track record of successful submissions to FDA including in?depth working knowledge of labeling and advertising regulations, guidance, and agency regulatory action history is required. Experience leading regulatory submissions for INDs and NDAs is essential. Experience with regulatory applications for devices and/or OTCs would be a plus.
Demonstrated excellent leadership skills with ability to lead and influence cross functional teams focused on attaining company goals
Experience providing strategic direction to interdisciplinary teams on promotional materials and activities related to the launch of new pharmaceutical products.
Experience and knowledge in preparation of regulatory submissions with explicit practical experience relevant to promotional communications.
Experience in interpreting regulations, guidelines, policy statements is required, including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to advertising, labeling and communications including direct-to-consumer prescription drug advertising and promotion in various media (print and virtual) preferred
Proven ability to foster effective, positive interactions with regulatory agencies and corporate partners
Ability to hire, guide, train, supervise, and prioritize workload of direct reports
Well organized and detail oriented with effective written and oral communications skills
OptiNose Inc. is a global Specialty Biopharmaceutical Company on a single minded mission to improve lives. Launched in 2010 on the foundation of a first technology acquired from Norway, and headquartered in Yardley, Pennsylvania, OptiNose today is comprised of highly motivated and highly accomplished professionals working from offices in the U.S., U.K., and Norway. OptiNose has both a proven recor...d of successful product development and a promising pipeline of new products.
The Company’s first products are based on a patented closed-palate Breath Powered® technology (also called “Exhalation Delivery Systems”). This technology is a platform for developing novel treatments that create meaningful new clinical benefits by enabling high and deep intranasal deposition of carefully selected medications. OptiNose successfully developed a first product in the Neurology therapeutic area (approved and launched as Onzetra™ Xsail™) and licensed North American commercialization rights to Otsuka (Avanir subsidiary).
OptiNose is also in late stage development of a potential new blockbuster product (OPN-375) to address the symptoms of millions of patients with chronic nasal inflammatory diseases (like nasal polyps and chronic sinusitis). The Company is poised to file an NDA for OPN-375, having already successfully completed initial global Phase 3 clinical trials. OptiNose is actively growing its team in preparation for a North American launch of this exciting new product, including commercial, supply chain, compliance, quality assurance and other key team members.
Looking further ahead, OptiNose has other pipeline products targeting large markets with significant unmet needs. These include nose-to-brain applications in the Central Nervous System therapeutic area (such as OPN-300 for Autism) and multiple opportunities in the ENT and Allergy therapeutic areas.
Dedicated professionals at OptiNose are building a new kind of organization from scratch without the encumbrances of a company with legacy systems and beliefs. Our team is unified by a shared mission: to improve lives. We will do this while creating great value for the healthcare system and great outcomes for investors. As innovators in every aspect of our work, we will pursue faster and less costly product development, will explore evolving commercial business models, and will actively seek innovative ways to be more effective and efficient. We will operate with an unwavering and overarching commitment to doing what is right. We are committed to working together as a team that chooses to live every day by core company values that guide our daily behaviors, creating a foundation for future success. These include Friendship, Possibility Thinking, Fearless Conversations, Openness, Authenticity, Perseverance and One Mission.