Coordinador de Asuntos Regulatorios

Johnson & Johnson

  • Panamá - GO
  • Permanente
  • Período integral
  • Há 14 horas
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.comJob Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob Category: ProfessionalAll Job Posting Locations: Panama, Panamá, PanamaJob 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#Li-HybridWe are searching for the best talent for Regulatory Affairs Coordinator to be in Panama City.Purpose:
The Regulatory Affairs Coordinator must ensure the implementation and execution of all activities necessary to comply with the strategies defined at the regional and/or local level to obtain sanitary registrations for new products and the maintenance of products already marketed in Venezuela,
Central America and the Caribbean.
Anticipates any changes in the regulatory environment of the cluster looking for strategic opportunities to contribute to the rapid access to markets. Proactively contributes with the cross-functional teams for the development of the commercial strategies of the business always maintaining the regulatory compliance of the strategy both with the internal policies of the company and with the applicable local regulations.You will be responsible for:1- Design and implement regulatory strategies in a timely manner to accelerate access of new and to accelerate the access of new and marketed products to different markets by markets through approvals from health authorities.2- Interact and align with internal partners (MAF, Access, Commercial) the activities necessary to manage and execute the business strategies that will and execute business strategies that enhance and ensure product launches.3- Supervise the regulatory activities and processes carried out by the local agents in each local agents in each of the countries, to guarantee the time committed to the business.4- Prepare product dossiers for submission to health authorities for new products and new indications5- Interact with health authorities to ensure that the dossier review and approval processes occur expeditiously. Ensure that post-registration commitments made to the health authorities are met without impacting business continuity.6- Ensure that the product portfolio under its responsibility complies with all regulatory labeling requirements and that any changes to it are duly approved by the authority and implemented by the company within the timeframe defined in the regulations.Qualifications / Requirements:
  • A bachelor’s degree in pharmacy or related sciences is required.
  • MBA, MRA or related is desirable.
  • Minimum experience of 3 years in regulatory affairs, preferably related to the pharmaceutical industry but considerable if related to the medical device and/or cosmetics industry.
  • At least intermediate english level
Other requirements
  • The regulatory affairs coordinator must be competent in:
o Planning and execution of processes and/or projects.
o Multidisciplinary verbal and written communication.
o Teamwork, both specialized and multidisciplinary.
o The management of interpersonal and/or public relations (authorities).I

Johnson & Johnson