Overview
Join to apply for the Director, Global Regulatory Leader role at Johnson & Johnson Innovative Medicine.
Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Regulatory Leader. This position is a hybrid role and will be located in High Wycombe, United Kingdom.
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.
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).
Job details
* Job Function: Regulatory Affairs Group
* Job Sub Function: Regulatory Affairs
* Job Category: Professional
* All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom
Responsibilities
* Be a key contributor/leader on the Global Regulatory Team and on multiple cross-functional teams.
* Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
* Ensure that regulatory strategies are aligned with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned).
* In interacting with the Health Authorities, lead and/or participate in meetings with FDA, Health Canada, EMEA and other Health Authorities as appropriate.
* Develop a regulatory strategy that will deliver global and/or regional needs with initial focus on the key markets identified.
* Ensure business compliance, and implementation of and adherence to regulatory standards.
* Serve as a member of Labeling Working Group (LWG) to create or update the Company Core Data Sheet (CCDS) and contribute to the development of local labels as appropriate. Provide regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.
* Provide integrated global labeling and filing strategy for assigned projects.
Qualifications
* A minimum of a Bachelor’s degree in a scientific discipline is required. An advanced degree (Master’s Ph.D, PharmD.) in a scientific discipline is preferred.
* A minimum of 10 years of overall regulatory experience with a Bachelor’s degree; 7 years with a Master’s or PharmD; or 5 years with a Ph.D. is required.
* Global regulatory experience is required.
* Experience leading interactions with Health Authorities is required.
* A broad understanding and experience in drug development, including early and late development is required.
* A broad understanding of lifecycle management is required.
* In-depth knowledge of current U.S. FDA, EMEA, Health Canada and global regulations as they relate to the overall regulatory strategy is required.
* Working knowledge of U.S. and/or global labeling requirements is preferred.
* Experience in the Neuroscience therapeutic area is preferred.
* Experience managing a portfolio of multiple products is preferred.
* Project management skills required.
* Must have excellent oral and written communication skills.
* Must have strong organizational, time management and multi-tasking skills.
* Must have effective critical thinking and problem-solving skills.
* The ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel solutions is required.
* The ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment is required.
* The ability to collaborate successfully in a matrixed environment as a leader and individual contributor is required.
* This position will require up to 10% travel.
Seniority level
* Not Applicable
Employment type
* Full-time
Industries
* Pharmaceutical Manufacturing
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