Regulatory Affairs Specialist

hace 2 semanas

Buenos Aires, Argentina Johnson & Johnson A tiempo completo

At
Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.

Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.

Regardless of your race, belief, sexual orientation, religion, or any other trait,
YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join
Johnson & Johnson , Your Move Could Mean Our Next Breakthrough.
At
Janssen , we're creating a future where disease is a thing of the past.

We're the Pharmaceutical Companies of
Johnson & Johnson , working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart.

We focus on areas of medicine where we can make the biggest difference:
Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
We are
Janssen.
Our mission drives us.
Our patients inspire us.
We collaborate with the world for the health of everyone in it.


We are searching the best talent for
Regulatory Affairs Specialist - Regulatory Affairs / Southern Cone to be in Buenos Aires.


Purpose:

As Regulatory Specialist, you will provide support in regulatory activities related to the life cycle of registered products (renewals, post-registration variations, etc.) and will be responsible for the artwork request process of printed packaging materials (labels, leaflets, cases, etc.), for all countries of the South Cluster (Argentina, Chile, Uruguay, Bolivia and Paraguay) and for the follow-up of such requests using an internal artwork management system.


You will be responsible for:

  • Collaborate in the timely execution of all regulatory activities related to the maintenance of product registrations in LA Sur markets (Argentina, Chile, Bolivia, Uruguay, Paraguay): renewals and postregistration changes.
  • Execute all activities of request for creation/change/update of packaging arts required for timely implementation (mockups, sales pack, etc), in compliance with a General Plan. Follow up on requests until final artwork is obtained through strong communication.
  • Agree and harmonize actions with stakeholders and markets involved. Process inquiries and requests that may arise during the process, obtain the necessary information to process it and manage the response. Plan workload, based on needs and clear definition of priorities.
  • Actively participate in new Process Excellence initiatives to optimize the quality of the processes in charge, ensure compliance with country regulatory requirements and ensure timely delivery.
  • Collaborate in the maintenance of updated product information in internal and external databases (National Drug Formulary).

Qualifications:

Qualifications and requirements:

  • Degree in Pharmacy, Biochemistry, Biotechnology (or related career).
  • English: advanced or upperintermediate level
  • Computer skills: MS Office environment
  • 1 year of experience in positions related to regulatory affairs.

Other Competencies and Skills:

  • Organizational ability to handle multiple activities, planning. Use competent use of time.
  • Ability to generate good interpersonal relationships.
  • Ability to contribute individually to the success and management of the team.
  • Proactive, achievement oriented with flexibility to function in a changing work environment.

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