Manager, Regulatory Scientist (1 of 3)

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.

Principal 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.

 

Qualifications:

• A minimum of a Bachelor’s degree in a scientific or technical discipline is required.  Advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline 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 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 proce