Johnson & Johnson Innovative Medicine
Manager, Regulatory Scientist (1 of 3)
Johnson & Johnson Innovative Medicine, Spring House, Pennsylvania, United States, 19477
Join to apply for the
Manager, Regulatory Scientist (1 of 3)
role at
Johnson & Johnson Innovative Medicine .
1 day ago – Be among the first 25 applicants.
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 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.
All Job Posting Locations: Raritan, New Jersey; San Diego, California; Spring House, Pennsylvania; Titusville, New Jersey.
Job Description Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager, Regulatory Scientist. This hybrid role can be located in one of the following: Titusville, NJ; Raritan, NJ; Spring House, PA; or San Diego, CA. The Manager, Regulatory Scientist is a regulatory specialist with project‑management capabilities responsible for supporting the end‑to‑end planning, coordination, and execution of assigned deliverables and providing support to the North America Regulatory Leader (NARL)/Global Regulatory Leader (GRL) for regulatory activities.
Principal Responsibilities
Lead and/or contribute to the planning, preparation (including authoring of regulatory documents such as 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, including views of HAs, regulatory precedents, labeling differences and therapeutic area‑specific issues.
Maintain working knowledge of local regulations and submission requirements for life‑cycle submissions, such as 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, and 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.
Qualifications
A minimum of a bachelor’s degree in a scientific or technical discipline is required; an advanced degree (Master’s, PharmD, Ph.D.) is preferred.
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 Harmonisation 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.
Experience in the neuroscience therapeutic area is preferred.
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.
Required Skills
Analytical Reasoning
Business Writing
Coaching
Fact‑Based Decision Making
Industry Analysis
Legal Support
Process Improvements
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments
Risk Compliance
Strategic Thinking
Technical Credibility
Preferred Skills
Analytical Reasoning
Business Writing
Coaching
Fact‑Based Decision Making
Industry Analysis
The anticipated base pay range for this position in U.S. locations is $117,000 to $201,250.
Benefits
Vacation – up to 120 hours per calendar year
Sick time – up to 40 hours per calendar year; for employees residing in 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 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
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an inclusive interview process. If you have a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers.
Seniority level
Not Applicable
Employment type
Full‑time
Job function
Legal
Industries – Pharmaceutical Manufacturing
#J-18808-Ljbffr
Manager, Regulatory Scientist (1 of 3)
role at
Johnson & Johnson Innovative Medicine .
1 day ago – Be among the first 25 applicants.
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 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.
All Job Posting Locations: Raritan, New Jersey; San Diego, California; Spring House, Pennsylvania; Titusville, New Jersey.
Job Description Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager, Regulatory Scientist. This hybrid role can be located in one of the following: Titusville, NJ; Raritan, NJ; Spring House, PA; or San Diego, CA. The Manager, Regulatory Scientist is a regulatory specialist with project‑management capabilities responsible for supporting the end‑to‑end planning, coordination, and execution of assigned deliverables and providing support to the North America Regulatory Leader (NARL)/Global Regulatory Leader (GRL) for regulatory activities.
Principal Responsibilities
Lead and/or contribute to the planning, preparation (including authoring of regulatory documents such as 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, including views of HAs, regulatory precedents, labeling differences and therapeutic area‑specific issues.
Maintain working knowledge of local regulations and submission requirements for life‑cycle submissions, such as 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, and 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.
Qualifications
A minimum of a bachelor’s degree in a scientific or technical discipline is required; an advanced degree (Master’s, PharmD, Ph.D.) is preferred.
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 Harmonisation 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.
Experience in the neuroscience therapeutic area is preferred.
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.
Required Skills
Analytical Reasoning
Business Writing
Coaching
Fact‑Based Decision Making
Industry Analysis
Legal Support
Process Improvements
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments
Risk Compliance
Strategic Thinking
Technical Credibility
Preferred Skills
Analytical Reasoning
Business Writing
Coaching
Fact‑Based Decision Making
Industry Analysis
The anticipated base pay range for this position in U.S. locations is $117,000 to $201,250.
Benefits
Vacation – up to 120 hours per calendar year
Sick time – up to 40 hours per calendar year; for employees residing in 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 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
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an inclusive interview process. If you have a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers.
Seniority level
Not Applicable
Employment type
Full‑time
Job function
Legal
Industries – Pharmaceutical Manufacturing
#J-18808-Ljbffr