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Associate Manager Regulatory Affairs

hace 2 semanas

Bogota, Colombia 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 are searching the best talent for Associate Manager Regulatory Affairs to be located in Bogotá, Colombia.

Purpose:
The Regulatory Affairs Manager is responsible for the overall management of the Regulatory Affairs activities to support and grow and the maintenance of the business in line with the company goals. The Manager leads all the regulatory affairs activities in LA North Cluster for the therapeutic areas under her/his responsibility.

This includes:

- Obtain and maintain marketing authorizations - define and implement the registration strategy for new products and maintenance of products on the market.
- Ensure fast introduction of new products and line extensions, including new indications.
- Maintain and support communications with Health Authorities and third parties.
- Ensure regulatory compliance.
- Streamline regulatory activities with other business partners.

**Responsibilities**:
**Regulatory Strategy**
- Co creates local regulatory strategy for new and marketed products in coordination with local and regional
- business partners.
- Develops filing/local submission plan for new products, and variations (including new indications, line extensions).
- Communicates and aligns filing plans and timelines with regional/global regulatory affairs (regional office and AP & LA liaisons).
- Identifies local data and dossier requirements (e.g., clinical trials, CMC, stability program, local studies, legal certificates).
- Provides strategic input by participating in internal working groups (CVTs); Interacts and aligns with internal/local business partners (e.g. Medical Affairs, Marketing, New business opportunities, legal, etc) to manage product strategy, local registration and launch activities..
- Ensures that project deadlines are met or escalated to relevant higher management
- Obtains local input from CVT to formulate local label strategy and input to company core data sheet and cascades it appropriately to the labeling coordinator of the country.
- Prioritize Regulatory affairs objectives and projects to best meet the needs of the Local Operating Company. Communicates accordingly.

**Registration and Post-Approval Dossiers**
- Oversights the preparation and submission of quality pre-and post-registration regulatory submissions.
- Conducts pre-submission activities ( e.g., Pre-submission meetings with Health Authorities).
- Customizes core registration dossiers for local submissions to Health Authorities.
- Interacts with Health Authorities related to pre-submission activities, review & approval processes and post-approval commitments.
- Addresses questions from HA related to approval process aligned with regional office and AP&LA liaisons.
- Tracks submissions and approvals and reports information in a timely manner to global regulatory affairs (e.g., submissions & approvals for original and line extension dossier, labeling, CMC variations, post
- approval commitments, HA inquiries).

**Compliance, Processes and Training**
- Ensures compliance with all regulatory requirements (e.g., timely submission of dossiers, timely tracking and reporting of submissions and approvals, timely implementation of new national legislation timely implementation and training of SOP’s and supporting systems [global, regional, and local], compliance with PKB).
- Develops and implements local SOPs / LIMS.
- Follows the training requirements/matrix for the region. Responsible for the regulatory local team training.
- Provides consultation, interpretation, and advice to other relevant groups in order to ensure compliance with regulatory guidelines/directives/national requirements.
- Acts upon product recalls as per local regulations and requirements.
- Ensures internal systems compliance by a periodic proactive review.
- Provides guidance on loc