Regulatory Affairs Coordinator - Bogota, Colombia - Johnson & Johnson

Johnson & Johnson

Empresa verificada

Bogota, Colombia

hace 1 semana

Publicado por:

Carolina González

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Descripción

At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for 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 Next Move Could Mean Our Next Breakthrough.

RESPONSABILITIES:

Responsible for regulatory activities to support and grow the business in line with the company goals wich includes:
Support in obtaining and maintaining marketingauthorizations;
Contribute to fast introduction of new products and line extensions including new indications
Ensure Regulatory compliance and lifecycle management.

LOC LAN:
(50% of Time)

- *Regulatory Intelligence: _

Shapes & influences the regulatory environment including working on or commenting on Health Authority policies and regulations.
This position could be a member of a local tradeassociations.
Works closely with Regional Office, global/regional

- *Regulatory Strategy _

Contributes to regulatory strategy for new and/or marketed products for LAN Countries depending of the scope of her/his responsibilities.
Identification of data requirements (e.g. clinical trials, CMC, stability program, local studies) and dossier/legal certificate requirements.
Interacts and aligns with internal/local business partners (e.g. Medical Affairs, Marketing, New business opportunities, legal, etc) to contribute with product strategy, local registration and launch activities.

- *Departmental management / Archiving _

Maintain the local product files in line with current registered authorization details according to the relevant local legislation.

- *New and existing products / Archiving: _

Prepare and submit regulatory submissions with support from regulatoryoperations.
Ensure deadlines for different projects are met or escalated to Regulatory manager and/or Head of RA.
Participate in internal working groups as required and address any regulatory actions with senior RA colleagues.
Request in the appropriate website's certificates, legal docs for new products (when the regional office is not responsible).
Keep internal websites updated.
Coordinate along with ASM and CQ, the implementation activities related to changes impacting supply,

- *LA North Cluster

RMC (50% of time) CMC Variations _
Evaluate, prepare and submit information related to variations in LA North Cluster (Colombia, Peru & Ecuador)
Coordinate with Regional responsible the changes and step to follow for eachvariation.
Responsible for designing the variation strategy and for maintaining and updating the databases.
Keep internal websites updated.

- *Special requirements: Compliance _

Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOP's & supporting systems).
Maintain an awareness of regulatory guidelines/directives/nationalrequirements.
Send spontaneous queries to the appropriateperson. Processes and Training
Contributes to the development and implementation on local Regulatory AffairsSOPs.

- *Other features of the job: _

Ongoing interactions with other members of local regulatory staff and regionaloffice.
Strong interpersonal and communication skills.
Ability to manage multiple tasks and projectssimultaneously.
Ability to work in a matrix organization and participate effectively both independently and as part of multiple teams.
Flexible, able to work under strict timelines.
Knowledge of relevant ITsystems.
Affinity with pharmaceutical product development.

Qualifications:

Minimum: degree in Life sciences or advanced student;
35 years of experience with Regulatorry Affairs and minimum of 3 years of relevant pharmaceutical industry experience;
Hands

- on experience in pharmaceutical productregistration;

Demonstrated ability to handle multiple projects;
Working knowledge of local regulations and guidelines related to drug development and registration;
Excellent verbal and written communication skills proficiency in written and oral English;
Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor;
Proficient use of technologyincluding MS office programs and Internet resources;
Leadership habilities/expertise;
Teamwork skills.