Submissions & Regulatory Intelligence Manager

7360-Janssen-Cilag Limited Legal Entity

High Wycombe

Hybrid

GBP 90,000 - 130,000

Full time

7 days ago

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Benefits offered by this job

Competitive salary and benefits

Flexible working environment

Job summary

Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager to lead regulatory data submission strategies within IDAR. You will ensure SDTM/ADaM standards across trials and collaborate with data management, statistics, and regulatory teams.

The role requires deep regulatory knowledge, strong leadership, and excellent English communication to support global submissions and process improvements.

Qualifications

Bachelor’s degree in a scientific, technology or healthcare discipline or equivalent experience.
Advanced degrees preferred (e.g., Master, PhD).
At least 6 years of pharmaceutical/scientific experience in data management, biostatistics, or clinical programming.

Responsibilities

Provide expert guidance on clinical data regulatory submission requirements and strategies.
Lead cross-functional projects and ensure compliance with regulatory requirements.
Serve as a main contact for data management, statistics, programming, and regulatory affairs teams.

Skills

Cross-functional leadership

Regulatory submissions

GCP/ICH knowledge

SDTM/ADaM

Data management

Clinical data standards

English communication

Education

Bachelor’s degree (science/healthcare)

Advanced degree preferred (Master/PhD)

Tools

SDTM tools

Regulatory submissions tools

Job description

Company Overview

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

Data Analytics & Computational Sciences

Job Sub Function

Clinical Data Management

Job Category

Professional

Job Posting Location

High Wycombe, Buckinghamshire, United Kingdom

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

Position Overview

We are searching for the best talent for a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR), to contributes to the Clinical Data Standards team as an individual contributor and a developing subject matter expert, to take a leadership role in the collaboration with various internal and external partners. The Submissions & Regulatory Intelligence Manager provides expert guidance and implements tailored solutions on projects, programs, and processes that span multiple related areas in support of the organization’s overall Clinical Data Standards strategy. Foremost is ensuring consistency of clinical data standards across clinical trials and in compliance with regulatory requirements.

Location Options

This role may be located in High Wycombe/Maidenhead, United Kingdom; Beerse, Belgium; Allschwil, Switzerland; Leiden, Netherlands; or Spring House/Raritan/Titusville, United States (Hybrid / 3 days onsite per week preferred).

Requisitions

Belgium/Netherlands - Requisition Number: R-103242
United Kingdom - Requisition Number: R-101253
Switzerland - Requisition Number: R-103247
United States - Requisition Number: R-103251

Purpose

Acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization. Manages standards, projects, programs, or processes for Clinical Data Standards in line with agreed internal strategy and regulatory requirements. Participates in the development of solutions to provide accurate, timely, and consistent clinical data standards to study teams. Communicates ideas for process improvement, while supporting the design and integration of new technologies to enhance clinical data standards. Coaches and trains junior colleagues in clinical data standards application and responsibilities. Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.

Key Responsibilities

The Submissions & Regulatory Intelligence Manager is responsible for providing significant expertise to the IDAR department (and GD if applicable) in clinical study data regulatory submission requirements and strategies. Examples of this content are:

Newly released or updated Regulatory Health Authority (RHA) and industry guidance documentation
Identification of clinical study data submission information critical to IDAR submission processes and procedures, including providing an interpretation of such information if needed
IDAR submission requirements and rules

The position serves as the single Point of Contact for any stakeholder on data management, clinical and statistical programming, and global regulatory affairs, for data submission deliverable requirements and makes sure these teams have a very clear understanding of these deliverables, the need for compliance, the difference between RHA requirements and the general submission processes.

The Submissions & Regulatory Intelligence Manager is responsible for acquiring and maintaining deep expertise in current RHA and industry guidance and RHA validation/compliance rules in relation to data submission packages (e.g., SDTM/ADaM submission packages). The position supports the ownership by SRI of any tools, system, checklists templates, etc., that facilitate data package compliance checking for IDAR.

The position may serve as the lead of the Submission Center of Excellence, serving as POC for study teams requesting SubCOE support, responsible for workload distribution amongst the team, working at the trial level post-DBL to ensure SDTM, ADaM, and documentation submission-readiness.

Qualifications / Requirements

A Bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience.
Advanced degrees preferred (e.g., Master, PhD)
At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming!
Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM)
Experience with regulatory submissions (NDA, BLA) is an asset
Demonstrated written and verbal communications skills
Demonstrated customer focus and solution-oriented experience
Demonstrated interpersonal skills to build relationships with internal and external business partners
Demonstrated leadership on cross-functional projects
Demonstrated leadership in decision making and problem solving
Excellent spoken and written English

Benefits

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance.
We offer career development opportunities for those who want to grow and be part of our organisation.

Equal Opportunity Statement

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Additional Required Skills