Manager Global Regulatory Scientist, Regulatory Affairs

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional 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 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) 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 Assist in the preparation of meetings with Regulatory Agencies. Coordinate, contribute to development, and review the content of responses to queries from HAs to ensure high quality and timely responses. May include other activities as delegated by the RRL/GRL. Liaise with LOCs, track dates of submissions/responses to queries in a timely manner. Acts as back up contact/representative on specific multi-discipline teams, or with regulatory agencies as needed. May be responsible for organizing and leading meetings. Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints. Supports GRL(GRT) by driving high project management planning of global submissions or Health authority interactions and additional major regulatory milestones. Participate in global regulatory team meetings as appropriate Assist in strategy development by researching regulatory and medical information in preparing submissions to Global Health Authorities (HAs). Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned Partner with regulatory colleagues