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 jnj.com
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Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, 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
We are searching for the best talent for Manager, Cross-Regional Operations & Strategic Support Regional Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; Horsham, PA; or Spring House, PA for a duration of about 13 months.
Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position. Candidates authorized to work pursuant to a short-term status (e.g., F-1) who require future immigration sponsorship are not eligible.
Purpose: This position resides within Global Regulatory Affairs and provides regional regulatory strategic implementation support for products in one or more therapeutic areas. This person is responsible for collaborating with the Global and Regional Regulatory Leaders, functional area experts and Local Operating Companies to implement/execute the company’s regulatory strategies for both marketed products and products under development in line with R&D, regional and local business objectives. This person will function in a matrix environment and must exhibit strong leadership skills. Responsibilities include:
You will be responsible for:
Implementing of the regional regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives.
Representing the regions and contributes to the regional & global regulatory strategy through participation in product-related teams such as, Global Regulatory Teams, submission teams, Labeling Working Groups, CTA Working Groups, response teams, clinical teams, etc., and provides team leadership where appropriate.
Advising product teams regarding regional and local requirements and impact of supply chain decisions on regional registrations to efficiently implement regional regulatory strategies.
Leading the Regional Working groups to ensure timely execution of product objectives and aligns regional deliverables with those of the global teams.
Facilitating tactical implementation at the regional level and ensures ongoing and effective communications with the regional and global teams on product activities and issues.
Leveraging TA, strategic, tactical, operational, and procedural synergies and efficiencies across regions.
Providing regulatory input for and appropriate follow-up to inspections, audits, litigation support and product…