Job Description

Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for an Associate Director, North America Regulatory Lead, Global Regulatory Affairs (GRA) Cardiovascular. The preferred locations are any of the following JNJ sites ; Raritan NJ , Titusville NJ or Springhouse PA. Other locations in the U.S. may be considered.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

Our company 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 Associate Director, North America Regulatory Lead, Global Regulatory Affairs (GRA) Cardiovascular, will support regulatory activities for assigned Cardiovascular TA projects/products.

Key responsibilities include the following:

* The NA Regulatory Leader participates in the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) if requested. Provides strategic input into the GRT for North America (NA). Leads and facilitates cross functional activities related to regional strategy. Serves as primary contact with North American Health Authorities (HA) &/or Operating Companies.
* The NA Regulatory Leader leads and oversees the preparation of dossier content according to the strategic plan for the region and health authority commitments. May also contribute to preparations for dossiers for other regions. Works with the GRT to develop global marketing approval submission plan and timing. Serves as a member of Labeling Working Group (LWG) to derive and update proposed Company Core Data Sheet (CCDS) and US Package Insert (USPI) based on target label. Participates in development of labeling negotiation strategies. Negotiates regional labeling with HAs, going through each of the back-up strategies if necessary. Identifies resources required for implementation of the Regulatory Functional Plan for the region and provides line management, coaching and guidance to direct reports (if applicable).
* The NA Regulatory Leader participates in project related global regulatory team meetings by providing regional input. Develops and implements North American regulatory strategy. Refines regional regulatory strategy as new data becomes available and re-assesses as necessary. Provides input on implications for regulatory strategy through participation in other product-related teams (e.g., Dossier submission teams, Clinical and Labeling working groups). Provides input into strategy with respect to clinical study design. Develops and updates contingency plans for regulatory strategies. Acts as back-up to Global Regulatory Leader (GRL) upon request. Within the context of the global strategy, determines timing, appropriate NA regional strategy and content for all HA meetings. Works with regulatory agencies on a daily basis, and leads and/or participates in other meetings with NA regulatory agencies as appropriate. Prepares company personnel for interactions with HA. Interacts with local NA commercial operating companies on individual products / processes. Contributes to preparations for Common Technical Document (CTD). Ensures that responses to FDA questions are handled in a timely manner and in line with the approved product strategy. Defines, generates, and submits appropriate data-driven responses to NA regional HA questions. Negotiates and manages NA regional post-approval commitments. Manages Adverse Experience (AE) safety reporting. Provides input to Submission Team to define submission plans including timing for new IND/CTA or IND/CTA amendments and HA reporting requirements; IND/CTA submission dossier content, scope and timing. Manages lifecycle management submissions (including safety reports). Provides input to and reviews submission documents to ensure they accurately answer the questions being posed and are consistent with HA commitments. Reviews labeling to ensure adequate documentation supports the regional labeling text. Approves submissions before dispatching to regulatory authorities.

Qualifications
Qualifications

* Minimum of Bachelor's Degree is required, a scientific or technical discipline is preferred.
* An advanced degree is preferred
* Minimum of 8 years pharmaceutical, medical device or health regulated industry experience with knowledge of the drug development process and regulatory submission and approval process is required.
* A Minimum of 5 years of pharmaceutical regulatory experience is preferred.
* Working knowledge of the regulatory environment, guidelines and practices as well as pre-and post-regulatory requirements is required.
* Previous experience working in the cardiovascular therapeutic area is preferred
* Previous experience interacting with health authorities is required
* Experience critically reviewing and compiling regulatory documents is required.
* Previous experience providing regulatory input to other product-related teams (e.g., Dossier submission teams, Clinical and Labeling working groups) is highly desireable
* Previous experience working Compound Development Teams (CDT) or clinical development is beneficial
* A proven track record to work successfully within a collaborative team environment, build positive relationships as an individual contributor is required.
* Able to prioritize and manage multiple complex tasks/projects within agreed timelines is required.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
United States-New Jersey-Raritan-920 US Highway 202
Other Locations
North America-United States, North America-United States-Michigan-Detroit, North America-United States-Georgia-Atlanta, United States-California-San Diego, United States-California-South San Francisco, United States-District of Columbia-Washington, United States-Florida-Tampa, United States-Illinois-Chicago, United States-New Jersey-Titusville, United States-New York-New York, United States-Pennsylvania-Spring House, United States-Texas-Houston, United States-Massachusetts-Boston, United States-Washington-Seattle
Organization
Janssen Research & Development, LLC (6084)
Job Function
Regulatory Affairs
Requisition ID
2105892300W