Janssen Research & Development, LLC is recruiting for an Associate Director, North America Regulatory Lead, Global Regulatory Affairs (GRA), Neuroscience. The ideal locations are Titusville, NJ; Raritan, NJ; Somerville, NJ; Spring House, PA; or Cambridge, MA.
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, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
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
The Associate Director, North America Regulatory Lead (NARL), GRA Neuroscience, will be responsible for leading North America (NA) regulatory strategy, working closely with the Global Regulatory Leader (GRL) for regulatory activities related to large and small molecule compounds in development and/or marketed products in the assigned portfolio within the Neuroscience therapeutic area. Key responsibilities include, but not limited to, the following:
- Developing and implementing NA regulatory strategy.
- Leading and facilitating cross functional activities related to regional strategy, including providing input on implications of regulatory strategy through participation in product-related teams (e.g., Clinical and Labeling working groups, Dossier submission teams).
- Providing regional regulatory input to the Global Regulatory Team and may participate in the Compound Development Team, if requested
- Serving as the primary contact with NA Health Authorities (HA) &/or Operating Companies.
- Within the context of the global strategy, determining the timing, appropriate NA regional strategy and content for all HA meetings.
- Leading and/or participating in meetings with NA HAs as appropriate.
- Preparing company personnel for interactions with HAs.
- Ensuring that responses to HA questions are handled in a timely manner and in line with the approved product strategy.
- Leading and overseeing the preparation of dossier content for INDs, BLAs/NDAs according to the strategic plan for the region and HA commitments.
- Performing critical reviews of submission documents to ensure compliance with regulatory requirements.
- Serving as a member of the Labeling Working Group to derive and update proposed Company Core Data Sheets and US Package Inserts based on target labels.
- Participating in development of labeling negotiation strategies.
- Providing input into strategy with respect to clinical study design.
- Negotiating and managing NA post-approval commitments.
- Partnering with the GRL to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and neuroscience-specific issues.
- Staying ahead of current and pending neuroscience approvals and maintaining working knowledge of laws, guidances and requirements related to neuroscience, in addition to general regulatory knowledge.
- Minimum of a bachelors or undergraduate is required. A degree in a relevant science is preferred
- An advanced degree (e.g., M.S., Ph.D., PharmD, JD) is preferred
- A minimum of 8 years relevant experience with a bachelor’s degree or a minimum of 6 years relevant experience with an advanced degree is required. Relevant experience includes experience in the pharmaceutical, medical device, or other health regulated industry, or experience working for a health authority
- Knowledge of the drug development process and regulatory submission and approval process is required
- A minimum of 5 years experience working in pharmaceutical regulatory affairs is required.
- An understanding of the drug product lifecycle from discovery to clinical trials to marketing is preferred.
- Therapeutic area experience in Neuroscience is beneficial
- Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is preferred
- Previous experience interacting with the FDA is required
- Experience critically reviewing and compiling documents is required
- A previous track record of success working successfully within a cross functional team environment as an individual contributor and decision maker is required
- A previous track record of success of effectively prioritizing assignments for multiple projects simultaneously is required.
- 10% domestic travel and potential international travel may be needed
Locations ONLY Titusville, Raritan and Somerville NJ: The anticipated base pay range for this position is $131,000 to $225,400.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
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
Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.
For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits