Regulatory Affairs Senior Manager La North Cluster - 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 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.

The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., rheumatoid arthritis, irritable bowel disease and psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), cardiovascular and metabolic diseases (e.g., diabetes) and Pulmonary Arterial Hypertension (PAH) and Rare Diseases.

Regulatory Affairs Senior Manager is responsible for the overall management of the Regulatory Affairs Department and all regulatory activities to support and grow the business in line with the

- company goals. The Head leads all the regulatory affairs activities in the country/ or countries under her/his responsibility.

This includes:

Management of the RA Department
Obtain and maintain marketing authorizations define and implement the registration strategy for new products

and maintenance of products on the market- Participate and contribute to the country business discussions

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
Influence the regulatory environment
People development

Based on local regulations and where applicable, the Head may be the legally responsible person towards Health Authorities.

PRINCIPAL RESPONSIBILITIES:

Regulatory Department Management:
Manages goals and objectives of the RA department in alignment with AP&LA regulatory affairs, regional

and country business goals and objectives- Plans, prioritizes, and manages resources of regulatory activities in alignment with objectives

Represents Regulatory Affairs to company senior management
Ensures implementation of standardization/new systems and processes to ensure efficiency and to support

business continuity, including management of incoming and outgoing correspondence and archiving.- Set ups Department Budget and its priorities. Follows up on expenditures.

People Development
Ensure direct reports receive appropriate training in the Regulatory Affairs environment and functional skills.

Encourage appropriate training and development

Set clear performance standards, provide feedback and coaching, and hold team members accountable for key

deliverables

Conduct annual performance reviews with direct reports to help support the creation of a diverse, high

performing RA organization

Provide leadership support to team members and act as a coach to the members of the RA team
Accountable for talent

- and career development of team-members

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 presubmission activities ( e.g., Presubmission meetings with Health Authorities)
Customizes core registration dossiers for local submissions to Health Authorities.
Interacts with Health Auth