Vice President, Innovative Medicine Regulatory Compliance

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

Job Function:
Legal & Compliance

Job Sub Function:
Enterprise Compliance

Job Category:
People Leader

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Essential Job Duties and Responsibilities:

The VP, Innovative Medicine Regulatory Compliance position reports into the VP of J&J Regulatory Compliance.

This role oversees all aspects of regulatory compliance within Innovative Medicine, ensuring the company's adherence to all applicable regulations, managing internal audits and maintaining a high state of readiness for regulatory inspections.

This involves developing and implementing strategic compliance plans, managing regulatory interactions, and building a robust compliance culture within the organization.

The position requires extensive communication with key stakeholders, health authorities, suppliers and other functional leaders.

This role will provide executive leadership for compliance teams including internal audits.

The VP will develop and implement strategies for new compliance programs and ensure effective regulatory performance.

The VP will engage with internal leaders and manage a team of 60+ professionals.

This leader should bring an understanding of supply chain strategy and manage key relationships to deliver on strategy.

This position must shape, connect, and lead resources to identify and resolve key compliance challenges.

Main Duties/Additional Duties/Sphere of authority


* Oversee the development and execution of Innovative Medicine regulatory compliance strategies, ensuring compliance with FDA, EMA, and other relevant global regulatory agencies.


* Applies deep understanding of compliance excellence to identify issues; partners with relevant health authorities, supply chain leaders, and external parties to deliver improvements and resolutions while striving for continuous improvement. 


*   Lead and oversee all aspects of inspection readiness, including developing and implementing inspection readiness programs, managing the response to inspection findings, and ensuring that all documentation is up-to-date and readily accessible.


* Is a key partner to Innovative Medicine leadership teams.

Helps shape strategy and prioritize innovation to impact the overall organization.


* Deve...