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R and D Regulatory Project Manager (28238) - Belgium   We are Urgently looking for a R and D Regulatory Project Manager

Fieldglass JNJ (company)


Functional titles : Regulatory Project Manager ,  Project Manager
FTE : 100 %
Min.Experience : 3 year
Start Date : ASAP
End Date : N/A
Posted on : 29 August 2017

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Project Description

Job Title:

Regulatory Program Manager

Member of:

Core member of Global Regulatory Team (GRT) and the Program Management Team (PMT) for a compound where appropriate.  Is a member of other business teams as assigned by the Head or People Managers.

 

 

Position Overview:

 

The RPM is accountable to both the Global Regulatory Leader and the PMO leadership for planning, executing, controlling, and reporting the functional regulatory plan in line with Regulatory and Compound strategy. As a core member of the Global Regulatory Team the RPM provides cross-functional operational and program management leadership for the development of therapeutic products or non-interventional healthcare platforms in a global, matrix organization, from entry to late development through complete of major lifecycle extensions.  RPMs are guided in all matters by our J&J Credo values and our Leadership Performance Standards.

 

 

Primary Duties:

 

·         The RPM works in partnership with the GRL to achieve the following results:

o   Translate the CDT/GRT strategy to functional plans with goals & objectives in alignment with organizational objectives. Contribute to and coordinate regulatory strategy updates over time; provide context and history to new GRT members/stakeholders. Utilize and embed GRA processes and tools to manage team and facilitate work.  

o   Drive the GRT to meet or exceed those goals by providing superior global cross-functional operational leadership and management in a matrix organization, facilitating issue identification and resolution, problem-solving, risk management, contingency planning and decision-making—the RPM challenges the status quo and leads innovation.

o   Manage the GRT in a manner that fosters and maintains a high-performance team culture; at the direction of the GRL. As delegated, chair GRT, GST, RRT meetings and lead operations for regulatory such as management of WW submissions, preparations for Health Authority meetings and other regulatory deliverables.

·         In collaboration with the GRT develops functional plans aligned with compound strategy.  Integrates WW submission strategy, maps pre-and post submission activities, manages delivery of regulatory components of submissions. Incorporates EMAX as appropriate

·         Facilitates the development of indication specific submission content. Optimizes the impact of the Global Submission Strategy Teams by ensuring the development and tracking of key messages. Utilizes GRA tools to manage this.

·         Challenge the team to be innovative, make it safe to try new approaches and take prudent risks. Coach the team to bounce back quickly from disappointments and learn from mistakes. Drive process improvements across the functions. Self-accountable for the GRT’s performance.

·         Work with standard budgeting and forecasting process and tools to manage GRT budget and resources estimates. Ensure all estimates are captured correctly in On Line system.

·         Manage GRT information, documentation, and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team and between co-development partners and/or other external partners (as required).

·         Individual leadership: motivate colleagues through personal example, and dedication to team goals. Inspire confidence and build group trust. Use emotional intelligence to spot signals others miss. Keep group focused on strategy and goals despite complexity, controversy, or conflict. Build bridges between organizations; turn adversity into opportunities for change and growth.

·         Primary duties listed above are not to be construed as exhaustive; other duties may be assigned by the PMO.

·         Demonstrated ability to resolve conflict and influence teams without formal authority is required.

Others

Project FTE 100%
Work from home:   Not Allowed
No. of Positions:   1

Personality

Adaptability Analytical thinking Approachability Assertiveness Attention to detail Collaboration Communicative Competitiveness Coordination Critical thinking Creative thinking Curiosity Efficiency Charm Flexibility Independence Innovative thinking Interest in knowledge Individuality Perspective Proactivity Responsibility Self-discipline

Knowledge

Regulatory Requirements Regulatory Compliance Research Governance Regulatory Strategies Understanding of regulatory guidelines

Skills and Expertise

Analytical skills Analyze data Interact with physicians Write papers Write protocols Advise on strategy Assemble regulatory applications

Degree

Bachelor

Certification

Regulatory Certification

Languages

Dutch
Professional Proficiency
Is a big plus
English
Professional Proficiency
Is a big plus

Desired Skills & Experience

Education:

·      A minimum of a Bachelor’s degree is required.

·      Post-graduate degree in Regulatory related field is highly preferred.

·      Post graduate degree in life sciences, engineering, or business management is preferred.

·      Regulatory certification (RAC) is preferred

·      Professional project management certification and/or diploma is preferred.

Experience:

·      5 years of relevant experience including at least 5 years in regulatory in (bio)pharmaceutical R&D.

·     Knowledge of regulations, guidelines and regulatory requirements is required

·     Prior experience as a member of a cross-functional team is required.

·     Experience in planning and management of global regulatory submissions (e.g. NDA, MAA, and lifecycle documents etc.) is highly preferred.

·     Demonstrated understanding of Global Regulatory Affairs processes, both pre- and post-marketing is highly preferred

·     Strong knowledge and comfort with MS Project or other management tools.

·     Successful experience managing or leading global and/or virtual teams is preferred, especially if done within a matrix organization.

 

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