Omrix Biopharmaceuticals is seeking a Sr. Regulatory Affairs specialist for our Ness Ziona site.
Reports to: RA Manager
Coordinates, compiles, and submits new product applications, investigation new product applications and post approval supplements to the regulatory agencies. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for new product application and investigation new product applications.
DUTIES & RESPONSIBILITIES
•Review and provide WW regulatory assessment for changes in approved product (CCs, Supplier notifications, New projects)
•Prepares and submit required regulatory applications for new products and maintenance of existing products with limited supervision.
•Prepare and maintain an annual and periodic plans of activities
•Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters with limited supervision.
•Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.
•Follows up of mandatory requirements for registration: local certificates, importation of samples and local testing, etc. with limited supervision.
•Monitors and submit regulatory applications for changes of approved products with limited supervision.
•Researches and consolidate regulatory requirements and communicate their information with supervisor and manager.
•Supports in the development of best practices for Regulatory Affairs processes
•Supports the RA team in projects, ensure record keeping and filing and submit reports and deliverable timely
•Partner effectively with key business partners to assure strategic objectives for Omrix are achieved.
•Act as an Omrix representative to projects handled as needed in the area of medical device, biologic and combination product registration
•Maintain professional knowledge
•Provides training and limited supervision of contract resources, as needed.
•Conforms regulatory compliance.
•A minimum Bachelor's degree – Pharmacy, Biology, Biochemistry, Chemistry
•Min. 3 years of progressive experience in Regulatory Affairs
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
•Leverages a working knowledge of the regulatory environment to prepare compliant Regulatory strategies and scientific and technical understanding of medical devices to provide regulatory input to product life-cycle management and evaluate regulatory impact on products.
•In depth understanding of Omrix manufacturing processes, analytical testing and
•Provide Regulatory Affairs support: Generates and manage submission documents for new products or changes to existing files.
•Must be able to proactively develop partnerships and alliances across the business.
Engages with external stakeholders and demonstrates conviction, proactivity and persistence when influencing others and overcoming resistance. Creates compelling negotiating positions that builds support and consensus among key stakeholders. And builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels.
•Track requirements of regulatory agencies and implement file updates accordingly
•Lead regulatory projects in cooperation with cross organization functions.
•Write and coordinate submissions and responses to health authorities in global market
•Effectively manages multiple competing priorities and collaborates with stakeholders with differing needs and viewpoints in order to make the best possible decision. And consistently manages large amount of changing, complex, ambiguous information and makes timely and effective decisions for the execution of project objectives.
•Delivers and creates oral and written technical communication with highlighting the most pertinent information for targeted stakeholders and leads to desired stakeholder actions.
•Acts with speed, agility and accountability in the decision making and balances short and long-term decisions and activities. Demonstrates an enterprise-wide mindset.
•High level English
LOCATION & TRAVEL REQUIREMENTS
•Location: Ness Ziona
•Occasionally Tel-Hashomer meetings and Business Travels
•Regular contact with Ministry of Health, FDA, EMA, Health Canada, ROW affiliates