Manager, Global Regulatory Scientist – Regulatory Affairs

Johnson & Johnson

Manager Global Regulatory Scientist supporting regulatory filings in health innovation at Johnson & Johnson. Collaborating on global submissions and compliance processes for medicines and devices.

Posted 7/18/2026full-timeSpring House • New Jersey, Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $117,000 - $201,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs with a strong focus on preparing and submitting applications to global health authorities, including IND, CTA, NDA, and MAA. Possesses a solid understanding of FDA and ICH regulations, along with experience in strategic planning and managing interactions with health authorities.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA Regulations KnowledgeICH Guidelines UnderstandingHealth Authority Interactions ManagementStrategic Planning Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsIND PreparationCTA PreparationNDA SubmissionMAA SubmissionLife Cycle ManagementClinical Trial ManagementTechnical Data SummaryCross Functional ManagementCombination Products Experience

Soft Skills

Intellectual CuriosityFlexibility in LearningCollaborationCommunicationProject Management

Industry Keywords

Pharmaceutical IndustryBiotech IndustryOncology Therapeutic AreaGlobal Health AuthoritiesRegulatory ProcessesProduct LabelingClinical ResearchHealth Authority QueriesRegulatory MilestonesRegulatory Input for Inspections

About the role

Key responsibilities & impact

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 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 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 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.

Requirements

What you’ll need

A Bachelor's degree in scientific or equivalent discipline; advanced scientific degree is preferred, and at least 6 years of health regulated industry experience, or a Master’s degree and a minimum of 5 years of health regulated industry experience or a PhD/PharmD with a minimum of 4 years of health regulated experience.
At least 4 years of relevant regulatory affairs experience in pharmaceutical/biotech industry is required.
Knowledge of multiple global health authorities ‘regulations and processes’ would be ideal
Solid understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, life cycle submission management and product labeling is required.
Therapeutic area experience in oncology is beneficial.
Experience with, combination products (drug and devices), would be an asset.
Intellectual curiosity and an ability/flexibility in learning new things and working in novel areas with limited regulatory precedence.
This role will include an opportunity to flex across different product types (pharma, devices, combo products).
Experience preparing responses to health authorities, managing Health Authorities interactions, and life cycle management of clinical trials and marketing authorizations submissions (ie: IND/CTAS/NDA/BLA, MAAS other).
Experience in strategic planning, technical data summary and cross functional management is required.

Benefits

Comp & perks

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year