Senior Manager, Regulatory Data Engagement

y. Learn more at https://https://www.jnj.com

Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Product Submissions and Registration
Job Category:
Professional
All Job Posting Locations:
Beerse, Antwerp, Belgium, Leiden, South Holland, Netherlands
Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-005432

United Kingdom - Requisition Number: R-010885

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

This is a remote role available within the United States, United Kingdom and Belgium. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are searching for the best talent for a Senior Manager, Regulatory Data Engagement to be located in Raritan, NJ; Spring House, PA; Horsham, PA, Malvern, PA; High Wycombe, United Kingdom; Beerse, Belgium; or Leiden, Netherlands.

Purpose: The Senior Manager, Regulatory Data Engagement in Global Regulatory Affairs plays a pivotal role in leading data-driven initiatives and aligning data management practices with regulatory requirements to ensure compliance and support of the development of innovative regulatory strategies. In this role you will be responsible for collaborating with cross-functional teams, external partners, and regulatory bodies to implement data strategies that support regulatory processes, ensure compliance with regulations, improve efficiency, and facilitate data-driven decisions.

You will be responsible for**:**

• Leading the creation and execution of a comprehensive data strategy for GRA that aligns with organizational goals.

• Ensuring that data management and analytics efforts support regulatory compliance, filings, and reporting requirements.

• Engaging data governance frameworks, data standards, and data quality metrics to enhance the efficiency and effectiveness of regulatory operations.

• Monitoring and assessing industry trends, standards, and best practices for regulatory data management and propose improvements.

• Collaborating with regulatory teams to identify key data needs and establish data collection, storage, and reporting processes.

• Leading cross functional teams on data-related regulatory projects, ensuring adherence to timelines, budgets, and compliance requirements.

• Identifying and managing risks related to data collection, storage, and reporting processes in GRA.

• Driving continuous improvement of data strategies and processes to adapt to changing regulatory environments and technologies.

• Leading and mentoring a diverse team of regulatory, data, and compliance professionals, providing guidance on data strategy and regulatory initiatives.

• Leading strategic planning sessions and drive alignment with senior leadership on data-related objectives for GRA.

• Cultivating a culture of innovation, continuous improvement, and accountability within the team, ensuring that team members have the resources and support to succeed.

• Collaborating closely with internal teams (GRA, Quality, Supply Chain, Commercial, IT, Data Science) to identify data needs and create actionable data-driven solutions.

• Serving as primary point of contact for data-related queries surrounding sponsored initiatives (e.g., IDMP, GRT analytical data needs).

• Building and maintaining relationships with regulatory agencies, internal teams, and external vendors to align data strategy objectives and regulatory compliance.

• Driving the use of advanced analytics and business intelligence tools to generate actionable insights for GRA to improve efficiency, reduce regulatory risks, and support decision making for regulatory data challenges.

• Working with Data Scientists and Analysts to develop predictive models that inform regulatory risk management and compliance strategies.

• Developing KPIs to measure the success of regulatory data strategies and compliance efforts.

• Overseeing the generation of reports, dashboards, and insights to track the progress and impact of data initiatives.

• Overseeing the adoption of new data tools, technologies, and strategies within GRA.

• Driving organizational change through training, best practices, and knowledge-sharing to enhance data-driven decision making across GRA.

Qualifications / Requirements:

• A minimum of a Bachelor's degree is required. An advanced degree is preferred.

Experience & Skills:

• 5+ years of experience in data strategy, regulatory affairs, or a related field with a focus on data governance, management, analytics, and compliance.

• Strong understanding of regulatory frameworks (e.g., FDA, EMA, ICH guidelines) and their impact on data management and strategy.

• Expert knowledge of IDMP regulations and standards.

• Proficiency with data management tools, analytics platforms, and reporting systems (e.g., Power BI, Tableau, SQL, or similar).

• Demonstrated experience in project management and cross-functional collaboration.

• Effective communication skills with the ability to engage and influence partners at all levels.

• Familiarity with industry regulations (such as ISO standards) is a plus.

• Knowledge of advanced data analytics techniques, such as machine learning or AI, in the context of regulatory data management.

• Strong analytical thinking and problem solving skills.

• Detail oriented with the ability to manage complex data-related regulatory challenges.

• Strong leadership and team collaboration skills.

• Excellent verbal and written communication skills.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

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