J&J Family of Companies Latin American Regional Regulatory Leader in Brazil
Latin American Regional Regulatory Leader
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 Latin American Regional Regulatory Leader - Manager is a member of the Global Regulatory Affairs organization. The position resides in the Latin American region or in the US and is responsible for working with the local regulatory affairs departments and global regulatory affairs department (e.g Global Regulatory Team, including the Regional Strategic Implementation group) to define and implement the LA regional strategy for assigned products. The position is responsible for providing region or country input into the global regulatory strategy and identifying regional requirements for successful regulatory filings for new products/indications, including the opportunity for placement of clinical trials within the region.
The position provides regulatory support to all affiliates in the region for the pharmaceutical sector business. It supports product variations, including labeling changes, supplements, and amendments; product license renewals; and Health Authorities query responses.
Position will work with regulatory policy professionals as well as local affiliates to keep track of changes in country regulatory requirements and provide regulatory intelligence to the global regulatory affairs organization.
Position would participate in preparation for presentations and meetings for LA health authorities.
Position works with regional leaders (Director and Associate Director/Sr. Manager), Global team members including Strategic Implementation team and local operating companies to define and implement the regional strategy for assigned products. Manages the development and implementation of multi-national /regional regulatory and strategies that optimize development, registration, and lifecycle management of new and marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.
1) Regulatory Strategy:
a) Develops robust regulatory strategies that are aligned with the local operating companies, LA IBVT (Integrated Brand Value teams) and global teams.
b) Collaborates with senior department members to expedite commercialization of key new products, new indications and line extensions via participation in the Regional Teams (IBVTs) to provide early regional regulatory inputs to identify barriers and needs to shape global developmental plan.
c) May participate in IBVT meetings
d) Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals.
e) Develop regulatory strategy & operational execution for variations & post marketing activities
f) Provides input in post-registration activities, including labeling changes
g) Provide regional implementation and regulatory-based advice on new and updated Core Data Sheets.
h) Collaborate on labeling activities following the REACH process
2) Health Authority and Operating Company Interactions:
a) Manages regulatory interactions with local operating companies and regional functions
b) Serves as global regulatory affairs point of contact with LA local operating companies
c) Interacts with local operating companies on individual products/processes
d) Facilitates discussions with local operating companies on regional or global regulatory issues, as required
e) Works with local operating companies to determine timing and strategy for regional HA meetings. Participate in preparations for HA interactions and assist local operating company with these interactions.
f) Tracks regional post-approval commitments and ensures appropriate follow-up actions
g) Tracks and updates tracking system of the major processes in the region
h) Manages approved products: variations, renewals, etc., including local and regional developed products.
a) Provides input to local operating companies related to submission tactical planning and timelines including submission during lifecycle (labeling changes, renewals and safety reports).
b) Maintains generic content plans for submissions in the region, including clinical trials and registration submissions
c) Reviews and provides input to critical submission documents.
d) Delivers on business critical regulatory submissions in accordance with development and/or post marketing priorities and timelines.
e) Participates in “Rapid Response Teams” to ensure appropriate and timely responses to HA questions. Provides clarification regarding HA questions and provides input to the strategy for responding to HA questions.
4) Participates in the development of department processes and procedures. Ensures that defined processes are developed and implemented within the regional regulatory office to track and communicate key regulatory product activities (including CCDS changes) and milestones
5) Updates global regulatory staff regarding changes in regional regulatory requirements and seeks to shape a favorable regulatory environment through networking with Industry Group
6) Provides regulatory training to new hires in LOCs or LA region regarding global and regional processes
1) Education level required and experience: Minimum Bachelors degree and at least 5 years overall experience (5+ yrs pharmaceutical, regulatory, etc) or Masters/PhD and at least 4 years; PhD and at least years of overall pharmaceutical experience.
Experience in Pharma or Medical Devices industry; Regional or country regulatory experience preferred;
Prefer experience in pharmaceutical product registration in Latin American countries, and familiarity with Latin American regulatory systems and product registration requirements, including previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry & Manufacturing, and/or Registration dossiers);
2) Required knowledge: Demonstrated leadership and contribution to drug development strategies; Demonstrated ability to handle multiple projects.
3) Required skills: Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor;
Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required;
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.
4) English is required. Spanish and Portuguese proficiency is preferred.
5) Regional business travel (5%) is required
6) Possible Location of the role: Sao Pablo, Brazil; Buenos Aires, Argentina; Ciudad de México, Mexico; Bogotá, Colombia, New Jersey, US.
United States-New Jersey-
Latin America-Mexico-Distrito Federal-Mexico City, Latin America-Colombia-Distrito Capital de Bogotá-Bogotá, Latin America-Argentina-Buenos Aires-Capital Federal, Latin America-Brazil-São Paulo
Janssen Research & Development, LLC. (6084)