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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.

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Job Function:

Regulatory Affairs Group Job Sub Function:

Regulatory Affairs Job Category:

Professional All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America 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 We are searching for the best talent for a Manager Global Regulatory Scientist, Regulatory Affairs. This hybrid work position will be in Beerse, Belgium, Leiden, Netherlands, High Wycombe/Maidenhead, UK, or Raritan, NJ and Spring House, PA (USA)

Job Description Manager Global Regulatory Scientist, Regulatory Affairs Key Responsibilities:

Under the direction of the GRL, RRL, your key responsibilities include the following:

• Draft cover letters and support the preparation of various applications ie: IND, CTA, MAA/NDA and eCTD), and procedures for Regulatory Agency submissions
• For CTA/INDs - Ensure protocols are in alignment with regulatory requirements and provide advise on required documents and submission strategies in preparation for those filings.
• For Marketing Authorization Applications (NDA, MAA or other major HA submissions): Provide regulatory support throughout registration process
• Advise team on required documents and submission strategies in preparation of

NDA, MAA

(and other global filings) as assigned (in collaboration with LOCs as appropriate)

• Assist with timely

NDA, MAA

(other) availability, ensure that all document components are in place on time, identify and track critical path activities

• Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, other)
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans .

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