Director, Global Regulatory Policy & Intelligence, Americas Policy Lead Job in Rockville, Maryland Us
Johnson Johnson Pharmaceutical Research Development, L.L.C., a member of Johnson Johnson's family of companies, is recruiting for a Director, Global Regulatory Policy Intelligence, Americas Policy Lead, located in Rockville, MD.
Johnson Johnson Pharmaceutical Research Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and developmen t areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The policy lead takes an ownership and leadership role in:Identifying regulatory and legislative trends and changes that have the potential to impact the development and marketing of JJ's pharmaceutical products. Providing high quality strategic input aimed at influencing the future healthcare environment. Partnering with the global or regional subject matter expert and groups including Local Operating Companies to engage in direct regulatory advocacy and influencing activities relating to regulatory healthcare policies. Actively engage in Trade Association initiatives, Health Authority policy focused meetings and consultation as well as contribution into the global pharmaceutical commenting system. Acting in a key liaison role with the US regulatory community, supporting US regional regulatory affairs and compound development with focused regulatory strategy support for FDA interactions, product development, and submissions to FDA.
The decentralized nature of JJ's business and the range of therapeutic categories in which it operates means this role will encompass a broad range of responsibilities that will need addressing with equal importance and measure of priority. With such diversity, this role delivers many challenges and complexities that offer the opportunity to scope and define its dimension to enable JJ to shape and influence the current and emerging regulatory environment.
Responsibilities include: Support JJ in interactions with FDA and other regional health authorities on advocacy issues, enhancing and fostering relationships with key decisions makers in policy and legislative areas and leverage insider status to gain insight and intelligence in the US. Lead and develop effective approaches to global, regional, or US regulatory policy activities, including generating of positions, influencing plans, tracking and internal communication. Participate in identifying, defining and implementing influencing strategies, partnering with project teams, subject matter experts, Government Affairs, Legal and local operating companies. Develop effective approaches to and participate in Trade Association initiatives, health authority meetings and consultations.
* Coordinate input into commenting on regulatory or legislative texts to help shape and influence key regulatory healthcare policies. Provide feedback to all JJ pharmaceutical companies and relevant personnel on current regulatory guidelines and procedures as well as emerging regulatory/legislative issues that impact JJ pharma businesses or products. Represent JJ at key trade association and agency meetings in collaboration with local, regional, or global regulatory leaders to carry out tactical operations in the representation of JJ's external regulatory policy strategy.
FDA-Focused and Team Support activites: Monitor US regulatory environment; evaluate potential impact on product development and approval. Interpret Agency statements and actions, including FR Notices and Guidance for Industry, for greater understanding by JJ teams and community. Leverage FDA insider status by liaising directly with Agency management and staff and gaining access to the Agency for JJ; drive management meetings with FDA officials. Manage resolution of critical FDA-related issues. Answer general FDA questions and serve as point of contact for the Agency. Provide advice and guidance on the development of regulatory strategies for drug development and communicating with FDA, ensuring strategic alignment and management of regulatory issues. Provide advice and guidance on achieving successful FDA meetings, including strategy for key FDA meetings and communication of key meeting outcomes to management. Leverage and communicate lessons learned across teams, therapeutic areas, and business units.
Qualifications
A Bachelors degree is required; preferably within a science, health or related field. An advanced degree in law, pharmacy, medicine, or life science-related discipline would be highly preferred. A minimum of 10 years of relevant pharmaceutical policy and regulatory experience is required. A minimum of 5 years of internal FDA experience also required. Must have expert knowledge about FDA, FDA staff and FDA policies. Must also have a complete understanding of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. Requires the ability to analyze new regulations or policies and assess the impact on the JJ pharmaceutical business or development programs. Excellent oral and written communication skills are essential for the position.The ability to influence will be key. Mostly local, but some regional travel is required (10%).
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