LA North Regulatory Affairs Manager

Job Description

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), and cardiovascular and metabolic diseases (e.g., diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
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 partner
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 local registration requirements. Develops local templates.
• Represents department in external/internal audits and gets involved in the actions derived from such audits that require Regulatory Affairs actions.
• Ensures a constant status of “inspection readiness”.
Regulatory Policy & Intelligence:
• Follows regulatory status of competitor products and assesses impact on regulatory strategy;
• Shapes & influences the regulatory environment including working on or commenting on Health Authority policies and regulations.
• Is an active member of regional and/or local trade associations
• Works closely with Regional Office, global/regional Policy/ Intelligence functions within J&J and APJLA liaisons.
• Informs in a timely manner change in the regulations and updates the internal systems accordingly
Qualifications
• Minimum: University degree in Pharmacy
• Regulatory Affairs experience (5+ years), desirable at both operational and strategic level
• Working knowledge of local regulations and guidelines related to drug development and registration
• Hands-on experience in biotech product registration
• Experience in Health Authority interactions. Ability to act as company spokesperson with Health Authorities
• Demonstrated project management skills
• Understanding of commercial business
• Demonstrated ability and flexibility to handle multiple projects and strict timelines
• 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
• Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment
• Proficient use of technology including MS office programs and Internet resources
DID YOU KNOW?
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Primary Location
Colombia-Distrito Capital de Bogotá-Bogotá-
Organization
Janssen Cilag S.A. (7060)
Job Function
Regulatory Affairs
Requisition ID
1905780352W