Job Description

Overall purpose of job:

Develop and lead regulatory affairs activities, strategy, operations and compliance activities in MOTUWA Markets Act as Regulatory Cluster Value team (RA CVT) member and as RA Expert for the corresponding Therapeutic Areas. Liaison and main contact between LOCs and international groups (Therapeutic Areas teams, CMC teams, Labelling teams, Regulatory Quality teams. Provide regulatory support for tenders and support daily business and products supply in accordance with J&J guidelines and local laws & regulations. Ensuring optimal compliance to local, regional and Janssen regulations, to minimize risk for the patient and Janssen business Take the Lead/Participate in ongoing Key Projects. Essential duties and responsibilities:

Act as Regulatory Cluster Value team (RA CVT) member and as RA Associate for the corresponding Therapeutic Area: RA CVT member Provide strategic and valuable RA input into CVT and Value excellence teams. Understand Business model and strategy drivers. Cooperation and partnership horizontally with commercial, MAF and other functions (Govern. Affairs, BQ, Human Resources, Logistics...), as well as vertically with IBVTs and Brand Teams to shape the CVT strategy and create added value. Act as regulatory representative on project teams and provide advice on specific projects contributing to the development of project plans and target product profiles. Ensure new products registration Execute regulatory plans and manage timelines to achieve the stated goals. Coordinate the preparation, review, submission and follow up of regulatory files that are properly formatted and in compliance with local regulations in MOTUWA. Track and follow up with local marketing authorization holder/distributor submission of regulatory files (including but not limited to: variations, response to questions) to local Health Authorities and ensure that filing and submission meet local requirements and company objectives. Distribute/share official notifications and HA information with internal stakeholders as applicable. Ensure close follow up with partners to ensure timely submission and reporting Maintenance and follow up of marketed products: Coordinate the preparation, review, submission and follow up of the products life cycle management in compliance with local regulations and Internal procedures. Distribute/share official notifications and HA information with internal stakeholders as applicable. And ensure reply to any HA query received on time. Ensure close follow up with partners to ensure timely submission and reporting Liaison and main contact between LOC and international & external stackholders Keep EMRL informed of regulatory status in LOCs and forward to them requests and relevant information from LOCs. Keep a timely and transparent communication flow of critical priorities and decisions. And keep alignment across different stakeholders (CVTL, TAL, EMRL, BUM) in timely manner. Key external participation in Industry groups with structured approach to share within internal teams Maintain archiving and appropriate databases and systems: Ensure electronic and paper tracking of regulatory activities and Marketing authorizations and lifecycle management via appropriate systems Populate and update appropriate J&J databases as per J&J processes. Update, maintain and use regulatory databases, tracking tables and information systems. Compliance Responsibilities a. Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and, where applicable, appropriately managed when planning projects, developing materials, executing projects and contracting vendors b. Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and, where applicable, complied when planning projects, developing materials, executing projects and contracting vendors c. Ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized

Core competencies required for this role:

Level of Proficiency

Industry and Marketplace High

Organizational Awareness High

Product and Therapeutic Area Knowledge and Patient Insight High

Medical Strategy Development Medium

Quality Management Medium

Clinical Activities Strategy, Planning and Design Low

Budgetary Skills and Performance Metrics Medium

Project Management High

Networking and Collaborating High

Communication and Interpersonal Skills High

Business Tools High

Travel: