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Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
São Paulo, Brazil
Job Description:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at Johnson & Johnson Innovative Medicine
We are searching for the best talent for these 2 positions of Manager Cross-Regional Regulatory Affairs - Fixed Term (12 months), based in São Paulo, Brazil.
Regional Regulatory Strategy Implementation
Drives and leverages cross-regional synergies and efficiencies
- Responsible for the development of strategic implementation plans.
- Understands regional and local requirements and advises the Global Regulatory Team (GRT), Compound Development Team (CDT) and regional teams on implementation issues pertaining to regional regulatory strategies.
- Participates as a member of the project related GRT; supports the GRT in the implementation of regional input into compound development, registration and life cycle management.
- Responsible for the implementation of the regional regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives.
- Understands how supply chain decisions impact registrations in the regions.
- Develops and updates contingency plans for the execution of regional regulatory strategies and refines regional plans as new data become available
- Leads the Regional Working group to ensure timely execution of product objectives, and aligns regional deliverables with those of the global teams.
- Facilitates tactical implementation at the regional level, and ensures ongoing and effective communications with the regional and global teams on product activities and issues, related to strategic execution.
- Represents the regions and provides input on implications for regional & global regulatory strategy through participation in other product-related teams (e.g., submission teams, Labeling Working Groups, response teams, clinical teams, etc.), and provides team leadership where appropriate.
- Works with regional RA Intelligence providers (e.g. GRPI, Regional Regulatory Leaders, LOCs) to deliver knowledge management to the organization. Contributes to a strong knowledge management base ( collection/sharing)
Health Authority and Operating Company Interactions
Basic understanding of worldwide health authorities and applicability of procedures to the regions
- Participates in the preparation for meetings with regulatory agencies in the regions.
- Liaises directly with Operating Companies, as needed, to support submissions to HA’s.
Submissions
- Responsible for the preparation and provides review and input on global, regional, and local documents for submission to Health Authorities in the regions.
- Responsible for the preparation of registration dossiers (e.g., International Common Technical Document (iCTD) and ASEAN Common Technical Document (ACTD)) and dossier re-use strategies.
- Works with the Regional Regulatory Leaders and GRT to develop regional marketing approval submission plans and timing.
- Manages and tracks country-specific requirements for local submission purposes (e.g. legal and technical documents, RMP)
- Responsible for submission tactical planning and timelines, including submission plans for the products’ life cycle, and communicates to relevant groups.
- Ensures follow-up of regulatory dossier after submissions.
- Oversees management of responses to questions asked by Health Authorities in a timely manner and in line with the product strategy.
- Liaises with the Regional Regulatory Leaders to advise the GRT, and as needed, CDT and R&D functional representatives, on required documents and processes to support HA contacts and submissions.
- On behalf of the regions, provides strategic input to CTA dossier content, scope and timing
- Contributes to the management of product lifecycle submissions (e.g., PSURs )
Labeling
- Serves as member of the Labeling Working Group (LWG) to provide regional input on proposed CCDS & updates
- Oversees development of labeling negotiation strategies for countries in the regions and development of supporting documentation for labeling.
Regulatory Input into Other Functions
- Engages GRL, Regional Regulatory Leaders and selected LOC representatives to enable execution of regional strategies
- Secures global resource deployment (e.g., Med Writing, Safety, PhD, Supply Chain) to ensure implementation of regional strategies.
- Provides regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints
Role within the Regional Regulatory Affairs organization
- Leverages TA, strategic, tactical, operational and procedural synergies and efficiencies across regions.
- Facilitates interactions between regional and global functions where needed.
- Analyses regional & HA feedback to foster adaptive learning.
- Tracks progress for assigned projects and generates reports for management as required
- Fosters and maintains ongoing communication and alignment with key stakeholders and business partners, including GRT, operational teams, regional teams and LOCs.
- As a member of the Regional Strategic Implementation Group participates in setting of operational direction
- Actively participates in other management and leadership activities
- Actively participates or provides leadership for process development or process improvement.
People Relationships
- Enhances engagement with regional teams through close proximity to R&D centers and global operational teams
- Facilitates management with regional/global teams (as needed)
- Coaches and mentors junior staff
- Has cross-regional and cross-functional leadership responsibility
Qualifications / Requirements
- Bachelor’s degree in a scientific field.
- 2–3+ years of Regulatory Affairs experience, including preparation and coordination of regulatory submissions.
- Experience with LATAM regulatory requirements and country-specific submission requirements.
- Previous experience in Medical Devices or Pharmaceutical industry.
- Advanced English, with strong verbal and written communication skills for interaction with global teams.
- Strong cross-functional collaboration and influencing skills, with the ability to lead initiatives without direct authority.
- Experience with EMEA and/or Asia-Pacific regulatory requirements is a plus.
- Experience with data analytics is a plus.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility