Regulatory Affairs Senior Manager La North Cluster

hace 2 semanas

Bogotá, Bogotá D.E., 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.


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

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