Manager, Global Regulatory Scientist – Regulatory Affairs

Johnson & Johnson

Manager Global Regulatory Scientist at Johnson & Johnson developing and managing regulatory affairs for pharmaceutical/biotech products. Collaborating on global submissions and ensuring compliance with health authorities.

Posted 7/18/2026full-timeBeerse • 🇧🇪 BelgiumMid-LevelSenior💰 €79,800 - €137,770 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory affairs with a strong focus on submission strategies for NDA, MAA, and IND applications, ensuring compliance with FDA and ICH guidelines. Proven ability to manage cross-functional teams and lead strategic planning efforts in the pharmaceutical and biotech industries.

Highest-signal resume keywords

Regulatory Affairs ExperienceNDA/MAA Submission ManagementFDA/ICH Regulatory KnowledgeStrategic PlanningCross-Functional Collaboration

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Submission PreparationClinical Research KnowledgeLife Cycle ManagementDocument Review and Quality AssuranceHealth Authority Interaction ManagementCombination Products ExperienceTechnical Data SummarySubmission Strategy DevelopmentOncology Therapeutic Area ExperienceRegulatory Compliance

Soft Skills

Strong Organizational SkillsEffective CommunicationConflict ResolutionLeadership CapabilitiesCritical Thinking

Industry Keywords

Health Regulated IndustryGlobal Health AuthoritiesPharmaceutical IndustryBiotech IndustryRegulatory RequirementsProduct DevelopmentClinical TrialsMarketing Authorization ApplicationsRegulatory Agency SubmissionsMatrixed Environment

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
Ensure protocols are in alignment with regulatory requirements and provide advise on required documents and submission strategies in preparation for those filings.
Provide regulatory support throughout registration process
Advise team on required documents and submission strategies in preparation of NDA, MAA as assigned (in collaboration with LOCs as appropriate)
Assist with timely NDA, MAA 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.
Act 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.
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).

Requirements

What you’ll need

A Bachelor's degree in scientific or equivalent discipline; advanced scientific degree is preferred
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.
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.
Strong organizational and time management skills.
Strong collaboration skills, including effective communication and conflict resolution skills.
Strong leadership capabilities and ability to work successfully in a matrixed environment.
Effective critical thinking, including problem solving and goal setting.
Demonstrated ability to think strategically and contingency plan in order to meet business objectives.

Benefits

Comp & perks

an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
vacation days
parental leave for a minimum of 12 weeks
bereavement leave
caregiver leave
volunteer leave
well-being reimbursement
programs for financial, physical and mental health.
service anniversary and recognition awards