Director, Global Regulatory Affairs – CMC

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:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Regulatory Science

Job Category:
People Leader

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://www.jnj.com/innovative-medicine

The Global CMC Regulatory Affairs Director is responsible for developing global CMC regulatory strategies and content plans according to scientific/risk-based regulatory strategies.

Principal responsibilities:

Regulatory Strategy


* Develop and execute global CMC regulatory strategy for one or more product(s).


* Refine regulatory strategy as new data become available and re-assess as necessary.


* CMC Regulatory Lead on CMC Teams.


* Represent CMC Regulatory viewpoint and expertise on the CMC/VST Team, Global Regulatory Team, including regulatory risk assessments and mitigations associated with proposed strategies.


* Develop and update contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product.


* Confirm CMC strategy is in alignment with Therapeutic Area, regional strategies, commercial strategy, and Quality Target Product Profile.


* Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed.

Submissions


* Work with the CMC team to develop CMC content and submission plans; able to prioritize based on business impact.


* Prepare regulatory (CMC) sections of development/project plans and provide strategy as issues arise to gain rapid approval with reasonable risk.


* Provide input to and be accountable for the preparation of dossiers for submission to Health Authorities (NDA/BLA/MAA/IRD/IND/CTA and post approval variations).


* Work with the GRT to develop global marketing approval submission plan and timing, complying with local regulatory requirements and commitments.

Health Authority Interactions


* In collaboration with Regional and/or local Regulatory Leader, as applicable:
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