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 Med Tech, 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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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 a unique 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.

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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

Draft cover letters and support the preparation of various applications e.g., 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 advice 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 the registration process.

Advise the 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 the timely availability of NDA, MAA (other) by ensuring that all document components are in place on time, identifying and tracking critical‑path activities.

Assist with the 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 the 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.

Act as backup contact/representative on specific multi‑discipline teams, or with regulatory agencies as needed; may be responsible for organizing and leading meetings.

Provide regulatory input and appropriate follow‑up to inspections, audits, litigation support, and product complaints.

Support 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 to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences, and disease‑area‑specific issues.

May assist in the development and improvement of regulatory processes.

Qualifications Experience And Skills

A Bachelor’s degree in a scientific or equivalent discipline; an advanced…