Director, Global Regulatory Leader - Oncology
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Global Regulatory Leader - Oncology.
This position can be located in Raritan, NJ; Titusville, NJ; Horsham, PA; Spring House, PA; Malvern, PA; Toronto, Canada; High Wycombe, United Kingdom; Leiden, Netherlands, Beerse, Belgium; Allschwil, Switzerland.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 are Janssen.
We collaborate with the world for the health of everyone in it.
Learn more at www.
janssen.
com and follow us @JanssenGlobal.
Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension.
Please visit http:
//www.
janssenrnd.
com for more information.
The Director, Global Regulatory Leader for Early and Late Oncology Development Projects (large and small molecules, and advanced therapy products) will integrate multiple inputs from regional and functional Global Regulatory Team (GRT) members to create innovative global regulatory strategies.
This individual will lead GRT(s) and the activities and responsibilities will include, but are not limited to, the facilitation and coordination of team meetings, representation of Global Regulatory Affairs (GRA) and provision of regulatory expertise on the Compound Development Team (CDT) and Clinical Team (CT) to facilitate successful product development globally and to provide input on governance recommendations.
Ensure regulatory strategies are developed to meet the needs of the project.
Refine regulatory strategies as new data become available and re-assess as necessary.
Develop and update contingency plans for issues that affect study initiation and registration scenarios especially as it relates to CTA and IND activities and ensure strategy is in alignment with Therapeutic Area portfolio, regional strategies, and the Target Product Profile.
Maintain strong partnership with Chemistry, Manufacturing and Controls (CMC) Leader and CMC Regulatory Affairs to ensure integration of manufacturing and clinical regulatory strategies.
Lead the preparation of regulatory dossiers for submission to Health Authorities (HAs) and modify submission plans and align with sourcing and Intellectual Property.
Establish Rapid Response Teams as necessary to develop and obtain alignment on global strategy for responses to HAs.
Work with the GRT to provide input for target labeling.
As a member of the CDT, provide feedback to other functions that may translate into potential new uses.
Participate in and conduct licensing evaluations as needed.
May support more than one compound within the Oncology portfolio.
Principal
Responsibilities:
Regulatory Strategy:
Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussion with global health authorities to find the best development strategies for novel therapies.
Integrate multiple inputs from regional and functional GRT members to create and execute a coherent and unified global regulatory strategy for one or more products.
Refine regulatory strategy as new data become available and re-assess as necessary.
Lead, facilitate, and coordinate GRT meetings.
Represent Regulatory viewpoint and expertise on the CDT, including regulatory risk/benefit evaluations associated with proposed strategies.
Provide direction on implications for regulatory strategy through participation in other teams (labeling working group, clinical, etc.
).
Be accountable for regulatory recommendations for governance processes.
Develop and update contingency plans for issues that affect study initiation, movement to full development, and registration scenarios.
Confirm strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-RA strategy, commercial strategy, and Target Label.
HA Interactions:
In collaboration with Regional and/or local Regulatory Leader, as applicable:
Determine timing and strategy for HA meetings.
Prepare company staff for interactions.
Lead meetings with HAs, when appropriate.
Develop strategy for providing responses to HA questions (ensure alignment with global strategy).
Understand procedures for working with HAs.
Understand procedures for approaching, influencing HAs.
Understand the history of positions HAs have taken on particular issues.
Submissions:
Provide input to and be accountable for the preparation of dossiers for submission to HA (IND/CTAs/NDA / MAA).
Work with the clinical and CMC teams to develop clinical trial submission plans.
Modify submission plan and align with sourcing, IP and if appropriate launch strategies.
Establish Rapid Response Team to develop and get buy-in on global strategy for HA responses as needed.
Work with GRT and CDT to comply with local regulatory requirements and commitments.
Understand HA procedures that need to be followed.
Understand how a HA perceives, handles and provides feedback to submissions.
Understand individual HA review practices.
Regulatory Input into Other Functions:
Conduct licensing evaluations as needed.
Work with the GRT to provide input for Target Label Co-lead the Labeling Working Group in making strategic decisions, including creation of Labeling strategy.
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.
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 CDT, review pertinent product/project-related communications, manuscripts and publications.
Recommended Skills Chemistry Clinical Trials Clinical Works Coaching And Mentoring Communication Filing Estimated Salary: $20 to $28 per hour based on qualifications.
This position can be located in Raritan, NJ; Titusville, NJ; Horsham, PA; Spring House, PA; Malvern, PA; Toronto, Canada; High Wycombe, United Kingdom; Leiden, Netherlands, Beerse, Belgium; Allschwil, Switzerland.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 are Janssen.
We collaborate with the world for the health of everyone in it.
Learn more at www.
janssen.
com and follow us @JanssenGlobal.
Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension.
Please visit http:
//www.
janssenrnd.
com for more information.
The Director, Global Regulatory Leader for Early and Late Oncology Development Projects (large and small molecules, and advanced therapy products) will integrate multiple inputs from regional and functional Global Regulatory Team (GRT) members to create innovative global regulatory strategies.
This individual will lead GRT(s) and the activities and responsibilities will include, but are not limited to, the facilitation and coordination of team meetings, representation of Global Regulatory Affairs (GRA) and provision of regulatory expertise on the Compound Development Team (CDT) and Clinical Team (CT) to facilitate successful product development globally and to provide input on governance recommendations.
Ensure regulatory strategies are developed to meet the needs of the project.
Refine regulatory strategies as new data become available and re-assess as necessary.
Develop and update contingency plans for issues that affect study initiation and registration scenarios especially as it relates to CTA and IND activities and ensure strategy is in alignment with Therapeutic Area portfolio, regional strategies, and the Target Product Profile.
Maintain strong partnership with Chemistry, Manufacturing and Controls (CMC) Leader and CMC Regulatory Affairs to ensure integration of manufacturing and clinical regulatory strategies.
Lead the preparation of regulatory dossiers for submission to Health Authorities (HAs) and modify submission plans and align with sourcing and Intellectual Property.
Establish Rapid Response Teams as necessary to develop and obtain alignment on global strategy for responses to HAs.
Work with the GRT to provide input for target labeling.
As a member of the CDT, provide feedback to other functions that may translate into potential new uses.
Participate in and conduct licensing evaluations as needed.
May support more than one compound within the Oncology portfolio.
Principal
Responsibilities:
Regulatory Strategy:
Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussion with global health authorities to find the best development strategies for novel therapies.
Integrate multiple inputs from regional and functional GRT members to create and execute a coherent and unified global regulatory strategy for one or more products.
Refine regulatory strategy as new data become available and re-assess as necessary.
Lead, facilitate, and coordinate GRT meetings.
Represent Regulatory viewpoint and expertise on the CDT, including regulatory risk/benefit evaluations associated with proposed strategies.
Provide direction on implications for regulatory strategy through participation in other teams (labeling working group, clinical, etc.
).
Be accountable for regulatory recommendations for governance processes.
Develop and update contingency plans for issues that affect study initiation, movement to full development, and registration scenarios.
Confirm strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-RA strategy, commercial strategy, and Target Label.
HA Interactions:
In collaboration with Regional and/or local Regulatory Leader, as applicable:
Determine timing and strategy for HA meetings.
Prepare company staff for interactions.
Lead meetings with HAs, when appropriate.
Develop strategy for providing responses to HA questions (ensure alignment with global strategy).
Understand procedures for working with HAs.
Understand procedures for approaching, influencing HAs.
Understand the history of positions HAs have taken on particular issues.
Submissions:
Provide input to and be accountable for the preparation of dossiers for submission to HA (IND/CTAs/NDA / MAA).
Work with the clinical and CMC teams to develop clinical trial submission plans.
Modify submission plan and align with sourcing, IP and if appropriate launch strategies.
Establish Rapid Response Team to develop and get buy-in on global strategy for HA responses as needed.
Work with GRT and CDT to comply with local regulatory requirements and commitments.
Understand HA procedures that need to be followed.
Understand how a HA perceives, handles and provides feedback to submissions.
Understand individual HA review practices.
Regulatory Input into Other Functions:
Conduct licensing evaluations as needed.
Work with the GRT to provide input for Target Label Co-lead the Labeling Working Group in making strategic decisions, including creation of Labeling strategy.
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.
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 CDT, review pertinent product/project-related communications, manuscripts and publications.
Recommended Skills Chemistry Clinical Trials Clinical Works Coaching And Mentoring Communication Filing Estimated Salary: $20 to $28 per hour based on qualifications.
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