Johnson & Johnson Innovative Medicine · 1 day ago
Manager, Regulatory Scientist (1 of 3)
Spring House, PA
Full-time
Hybrid
Mid, Senior Level
$117K/yr - $201K/yr
4+ years expJohnson & Johnson Innovative Medicine is dedicated to healthcare innovation, aiming to improve health outcomes through advanced treatments. The Manager, Regulatory Scientist will support regulatory activities, manage submissions, and collaborate with cross-functional teams to ensure compliance and strategic development in the regulatory space.
Pharmaceuticals
Responsibilities
Lead and/or contribute to the planning, preparation (including authoring of Regulatory documents e.g. Cover Letters, Health Authority (HA) Forms, etc.) and delivery of simple and more complex submissions throughout the product’s life cycle from either a global and/or regional perspective
Partner with the NARL/GRL to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and therapeutic area specific issues
Maintain working knowledge of local regulations and submission requirements for lifecycle submissions, e.g., protocols and protocol amendments, informational amendments, annual reports, IND Safety Reports, PADERs and PSURs
Manage submission delivery of all application types per market and /or region
Serve as the Regulatory representative on specific multi-discipline teams, may be responsible for organizing and leading meetings
Assist in strategy development by researching regulatory and medical information in preparing submissions to regional HAs
Understand the regulatory framework, including regional trends, for various types of applications and procedures
Review and interpret related product approval information and current HA guidances and Advisory Committee meetings
Maintain up-to-date knowledge of regulations and industry environment and provide guidance on potential trends
Coordinate, contribute and review the content of responses to queries from HAs for respective/regions and countries ensuring they are of high quality and submitted in accordance with timelines
May have interaction with internal and external colleagues with coordination between departments
May represent Johnson & Johnson externally with some degree of supervision
Qualification
Required
A minimum of a Bachelor's degree in a scientific or technical discipline is required
A minimum of 4 years of relevant Regulatory Affairs experience in pharmaceutical, biotech or consumer over the counter (OTC) industry is required
Understanding of FDA and International Council for Harmonization Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory requirements and guidelines, specific to the areas of clinical research, product development, and labeling, is required
Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required
Knowledge of Health Authority (HA) organizational structure and processes for reviewing submissions is required
Must have excellent oral and written communication skills
Must have strong organization and multi-tasking skills
Must have the ability to proactively anticipate issues, exercising judgment in developing new approaches/solutions and resolving conflicts/issues
Must have strong leadership capabilities with the ability to work successfully in a matrixed environment
The ability to effectively prioritize assignments for multiple projects simultaneously is required
The ability to collaborate with all levels and influence decision-making within a cross-functional organization is required
This position may require up to 10% travel
Preferred
Advanced degree (Master's, PharmD, Ph.D.) in a scientific or technical discipline
Experience in the Neuroscience therapeutic area
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Pension
401(k)
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 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
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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