Associate Director Regulatory Affairs World Without Disease and Lung Cancer Initiative

At J&J, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. The World Without Disease (WWDA) and the Lung Cancer Initiative (LCI), which is a cross-sector initiative, are charged by the Executive Committee of J&J with meaningfully altering the course of diseases, such as Type 1 Diabetes and lung cancer with a focus on interception and even cure. Please visit World Without Disease | Johnson & Johnson (jnj.com) and http://www.jnj.com/innovation for more information.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.

Janssen Research & Development, LLC is currently recruiting for an Associate Director Regulatory Affairs, WWDA/LCI. The position will focus on a range of novel product solutions across the disease areas supported, but with a primary focus on the Lung Cancer Initiative. Location can be flexible. The primary focus of this role is to support EU activities, but NA and/or global support to be provided pending on need) The preferred location is for individuals based in the EU (UK, Belgium, Netherlands).

Activities and responsibilities will include, but are not limited to:

• Participates in the Global Regulatory Team (GRT) and may participate in the Solution Development Team (SDT) if requested. Provides strategic input into the GRT for regions of focus. Leads and facilitates cross functional activities related to regional and/or global strategies as required. Serves as primary contact with Health Authorities (HA) &/or Operating Companies.
• Leads and oversees the preparation of dossier content according to the strategic plan for the region(s) and health authority commitments. 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 global labels, 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, mentorship and guidance to direct reports (if applicable).
• Provides input on implications for regulatory strategy through participation in product-related teams (e.g., Dossier submission teams, Clinical and Labeling working groups).

• As a member of the clinical team, provide input on study design, conduct, country selection, and monitoring and identify need for any additional studies; Provide feedback to Discovery and other functions that may translate into potential new compounds and uses; Develops and updates contingency plans for regulatory strategies.

• Reviews and provides regulatory input on regional Investigator Initiated Proposals. Acts as back-up to Global Regulatory Leader (GRL) upon request.
• Builds appropriate regional or global strategy(ies) and implements them. Determines timing, and content for HA meetings within the context of the global strategy.
• Refines regional regulatory strategy as new data becomes available and re-assesses as necessary.
• Works with regulatory agencies on a daily basis, and leads and/or participates in other meetings with regulatory agencies as appropriate.
• Prepares company personnel for interactions with HAs.
• Contributes to preparations for Common Technical Document (CTD).
• Defines, generates, and submits appropriate data-driven responses to assigned regional HA questions. Ensures that responses to Health Authority questions are handled in a timely manner and in line with the approved product strategy.
• Negotiates and manages regional post-approval commitments.
• Manages Adverse Experience (AE) safety reporting as required.
• Provide input to and is accountable for the preparation of dossiers for submission to HA (NDA/MAA/IRD/IND/CTA); Work with the clinical team to develop clinical trial submission plans; Work with others to develop global marketing approval submission plan and timing; Modify submission plan and align with sourcing, IP and launch strategies;
• 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.
• Approves submissions before dispatching to regulatory authorities.
• Builds positive relationships and interacts with commercial operating companies on individual products / processes.

Additional Responsibilities of this position include:

• Ensure development and/or implementation of processes and procedural documentation to support compliance with HA and J&J requirements;
• Follow-up on regional/local labeling strategies and supporting documentation for labeling; Coordinate and follow-up variations and label update submissions to keep product compliance;
• Track information on submissions and approvals in collaboration with GRT team and CMC group; HA Interactions in collaboration with Regional and/or local Regulatory Leader, as applicable;
• Build Rapid Response Team to develop and get consensus on global strategy for HA responses as needed; Work with GRT and SDT to comply with local regulatory requirements and commitments;
• Provide input to commercial Drug Product formulation, manufacturing site(s), and commercial packaging selection as decisions can have an impact on the filing strategy;
• Provide input into risk/benefit assessment; Work with GRT to direct, manage and resolve any “issues” as required with dedicated resources; Consult with Regulatory Legal and Healthcare Compliance to address pertinent issues; As part of SDT, review pertinent product/project-related communications, manuscripts and publications

Qualifications

• A Bachelor’s degree in a scientific discipline is required and at least 9 years of health regulated industry experience, or an advanced degree and a minimum of 7 years of health regulated industry experience.
• At least 5 years of relevant regulatory affairs experience is required.
• An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.
• Wide range of experience in Regulatory Affairs and experience leading interactions with Health Authorities is required;
• Experience with EU regulatory procedures (CP, MRP, national) is required, experience and knowledge of other global HAs would be highly beneficial
• Experience with companion diagnostics, combination products and/or biomarker development is preferred, Experience with medical devices is beneficial but not required
• Therapeutic area experience in oncology is desired.
• Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.
• The ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization is required
• The ability to effectively prioritize assignments for multiple products and projects simultaneously is required.
• Intellectual curiosity and an ability/flexibility in learning new things and working in novel areas with limited regulatory precedence. This role will include an opportunity to flex across different therapeutic areas and product types (pharma, devices, combo products).
• Ability to maintain knowledge of competitors in the therapeutic area and what they are doing in early/late development and knowledge of labeling aspects required;
• Experience managing a portfolio of multiple products required;

This position will require approximately 10 – 20%% travel, both International and Domestic.

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 Kingdom-England-High Wycombe-
Other Locations
Europe/Middle East/Africa-Spain-Community of Madrid-Madrid, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID
2105969760W