Job Description
Director, US Regulatory Policy & Intelligence
Johnson & Johnson Family of Companies
San Francisco, CA
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, US Regulatory Policy & Intelligence with a preferred location in Rockville, MD however remote flexibility may be considered.
Janssen Research & Development, L.L.C. Develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, cardiovascular, oncology, infectious disease, vaccines, diabetes, hematology, metabolic disorders, and immunologic disorders.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including:, cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), Oncology, Immunology, and Infectious Disease. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com.
Janssen thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.
The Director of US Regulatory policy takes a leadership role in:
Actively shaping and influencing policy impacting Janssen pharmaceutical development in the regulatory environment including laws, regulations, and guidances. This position will have a specific role in understanding/shaping of digital R&D policy.
Serving as a regulatory policy expert and/or lead of cross-functional teams responsible for proactively monitoring, responding and shaping emerging scientific trends/strategies (internal and external).
Providing strategic input and tactical support to global project teams, with the goal of empowering informed decision-making to bring products to market and maintain their availability for patients.
Partnering with global or regional subject matter experts and groups to lead direct regulatory advocacy and influencing activities relating to regulatory policies; with focus on digital R&D policies.
Actively engaging in Trade Association initiatives, Health Authority policy-focused meetings, and public-private initiatives to shape regulatory policy in alignment with Janssen R&D agenda.
The decentralized nature of J&J’s pharmaceutical business and the range of therapeutic categories in which it operates means this role will encompass a broad range of responsibilities that will need to be addressed with equal importance and measure of priority. With such diversity, this role provides many opportunities to work on complex, multifaceted issues and to lead a regulatory policy function that will enable J&J to shape and influence the current and emerging US regulatory environment.
Policy
Lead interactions with FDA on advocacy issues, enhancing and fostering relationships with key decision makers in policy and legislative areas, and leverage regulatory policy to gain insight and intelligence in the US.
Create effective approaches to US regulatory policy activities, including generating positions, advocacy plans, stakeholder analysis, tracking, and internally communicating.
Identify, define and implement advocacy priorities and strategies for the US, working with colleagues across J&J, project teams, Government Affairs, and Legal, including regulatory affairs colleagues.
Develop effective approaches to, and participate in, Trade Association initiatives, FDA meetings, and consultations particularly as they pertain to digital health.
Lead global regulatory commenting efforts and facilitates the input of Janssen expert information to help shape and influence key regulatory policies.
Advise J&J Pharmaceutical companies and relevant personnel on current regulatory guidelines and procedures as well as emerging regulatory/legislative issues that impact Janssen businesses or products.
Lead positioning at key trade association and agency meetings to further J&J’s external regulatory policy strategy.
FDA-Focused and Team Support
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 J&J teams and community.
Provide input to resolution of critical FDA-related issues.
Serve as point of contact for FDA and answer general Agency questions on assigned policy areas (e.g. Digital R&D)
Leverage and communicate lessons learned across teams, therapeutic areas, and business units.
Interprets the applicability of regulatory guidelines and processes to propose innovative solutions to regulatory challenges and areas of policy influence.
Works across different businesses and cultures on a worldwide basis to ensure global alignment and compliance with key stakeholders.
Leads teams of diverse subject matter experts to develop company positions.
Develops effective relationships and communication channels strategies across highly complex global organizations of multifunctional personnel.
Independently assess priorities and initiate cross-functional internal and external projects
Qualifications
Qualifications:
A minimum of an undergraduate degree is required .
An Advanced degree (MD, Ph D, PharmD) desirable is beneficial
A science- based, health policy or legal studies degree is preferred
At least 10 years of regulatory and/or drug/biologic development experience is required,
Previous experience working for a Health Authority experience is desirable
A minimum of 5 years in a regulatory policy or health policy role is required
A demonstrable history of regulatory success over multiple years driven by a strong understanding of the regulatory and legislative environment is required
Authoritative knowledge of the drug development process and , pharmaceutical business is required
A successful track record demonstrating an ability to analyze new regulations or policies and assess the impact on the pharmaceutical business or development programs is required
Organizational awareness (e.g., interrelationship of departments, business priorities), is preferred
Previous experience working cross functionally and in global teams is desirable
Strong management, interpersonal, communication, negotiation and problem solving skills
A proven ability to drive, challenge and improve the regulatory environment is required
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
United States-Maryland-Rockville-1700 Rockville Pike, Suite 445
Other Locations
North America-United States-Indiana-Indianapolis, North America-United States-Michigan-Detroit, North America-United States-Texas-Dallas, North America-United States-Maryland-Baltimore, United States-California-Irvine, United States-California-San Diego, United States-Delaware-Wilmington, United States-Florida-Jacksonville, United States-Florida-Miami, United States-Florida-Tampa, United States-Illinois-Chicago, United States-New York-New York, United States-Ohio-Cincinnati, United States-Texas-Houston, United States-Texas-San Angelo, United States-California-San Francisco, United States-Virginia-Richmond, United States-Pennsylvania-Philadelphia, United States-Massachusetts-Boston, United States-Washington-Seattle
Organization
Janssen Research & Development, LLC (6084)