Regulatory Affairs Process and Data Compliance Leader

Johnson & Johnson-posted 3 days ago
Full-time • Mid Level
Hybrid • Spring House, PA
5,001-10,000 employees
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com 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://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for a Global Regulatory Affairs Process and Data Compliance Leader. This position is a hybrid role and will be located in Spring House, PA. Please Note: An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. The Regulatory Affairs (RA) Process and Data Compliance Leader will serve as a strategic and operational leader responsible for driving alignment and consistency of processes and data across Regulatory Affairs therapeutic areas and in collaboration with regional and functional leaders to enable successful design, implementation and adoption of a unified regulatory platform. This role will ensure that business needs across Regulatory TAs are represented in platform design configurations in alignment with Industry standards and best practices. Additionally, the leader will serve as key bridge with the TA end-users and core team to drive user engagement to enable organizational readiness, change adoption and sustainable use of the regulatory platform.

  • Lead collaboration with subject matter experts (SMEs) and business leaders across therapeutic areas to define and align on standardized regulatory processes and data standards that support the unified platform.
  • Represent therapeutic area (TA) regulatory needs in design and testing phases of the platform.
  • Champion consistent ways of working across TAs, regional and business functions to ensure decisions and data is interoperable and compliant.
  • Partner with the Unified Regulatory Platform (URP) Core team to translate TA needs into scalable requirements, process designs and workflows.
  • Mobilize SMEs to enable data migration, enrichment and data readiness for TA owned data elements.
  • Drive readiness activities within each therapeutic area by coordinating communications, engagement sessions, and onboarding for TA business users.
  • Provide TA-specific insight during user acceptance testing, validation, and implementation phases to confirm that processes support regulatory efficiency and data quality goals.
  • Collect, consolidate and escalate feedback to improve user experience and data quality.
  • Collaborate with training and communication teams to deliver tailored content that reflects TA-specific use cases and process variations.
  • Monitor adoption cross-TAs and contribute to continuous improvement efforts and compliance with process and data standards.
  • Management and coordination of project coordinator(s) for TA-specific data assets for insights, analytics and intelligence.
  • Engage in strategic discussions and provides recommendations based on analysis to drive optimization.
  • A minimum of a Bachelor’s degree is required, preferably in a scientific, business or technical discipline. Master’s degree preferred.
  • A minimum of 10 years of overall work experience is required.
  • A minimum of 6 years of experience in the pharmaceutical or healthcare industry is required.
  • Knowledge of core regulatory systems (e.g., RIM, labeling, Registrations, etc.) is required
  • Experience in R&D operations or related field is preferred.
  • Experience in leading and influencing senior-level management and key stakeholders is required.
  • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables is required.
  • Experience with collaborating with IT and business partners to define metadata aligned with industry frameworks (e.g., ICH, IDMP, etc.) to ensure data consistency, interoperability and compliance across regulatory systems is required.
  • Experience with IT system design, development and implementation is preferred.
  • Must have excellent verbal and written communication skills with the ability to communicate effectively with all levels of the organization.
  • Must have strong analytical and problem-solving skills.
  • Must be comfortable challenging the status quo and bringing forward innovative solutions.
  • Must have the ability to work independently and in a team environment.
  • Demonstrated ability to work across functions, regions, and cultures is required.
  • The ability to interpret how structured and unstructured data is created, consumed and exchanged across regulatory, quality and clinical systems is required.
  • The ability to use insights from data to inform strategic decisions and compliance risk mitigation is required.
  • This position will require up to 10% domestic and international travel.
Track Jobs with Teal

Job Search Resources

•
Resume Builder
•
Regulatory Compliance Manager Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service