Manager, Regulatory Scientist (1 of 3)

Johnson & Johnson•Titusville, NJ

13d•Hybrid

About The Position

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. Learn more at https://www.jnj.com Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America 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 Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager, Regulatory Scientist. This position is a hybrid role and can be located in 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 provides support to the North America Regulatory Leader (NARL)/Global Regulatory Leader (GRL) for regulatory activities.

Requirements

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.

Nice To Haves

Advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline preferred.
Experience in the Neuroscience therapeutic area is preferred.

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.

Benefits

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits: 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
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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year

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