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Senior Regulatory Affairs specialist

Description

Omrix Biopharmaceuticals is seeking a Sr. Regulatory Affairs specialist.
location Nes Ziona, Israel
Reports to: RA Manager

JOB SUMMARY:
Plans, coordinates, compiles, and submits new product applications, investigational new product applications and post approval supplements to regulatory agencies in multiple regions. Assembles information necessary for submissions in accordance with regulations and relevant guidelines. Ensures compliance with regulatory agency regulations and current thinking. Prepares responses to regulatory agencies' questions and other correspondences.
Leads regulatory specialists and reviews early stage regulatory strategies and submission packages. Involved with the preparation of necessary outlines, summaries and status reports. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for new product application and investigational new product applications.

DUTIES & RESPONSIBILITIES:
•Review and provide regulatory assessment for changes in approved product, in coordination with regulatory affiliates in global regions
•Prepare and submit required regulatory applications for new products and maintenance of existing products with limited supervision
•Prepare and maintain an annual and periodic plan of activities
•Support other RA specialists: provide guidance to junior members, track team’s assignments, reviews regulatory strategies and submissions
•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 the information to RA and project managers
•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 deliverables timely
•Partner effectively with key business partners to assure strategic objectives for Omrix are achieved
•Provides training and limited supervision to regulatory specialists

Requirements

•Minimum of a B.Sc. in engineering, biological, pharmaceutical, or chemical sciences
•Minimum of 3 years of progressive experience in Regulatory Affairs

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS:
•Leverages working knowledge of the regulatory environment to prepare compliant regulatory strategies, provide regulatory input to product life-cycle management and evaluate regulatory impact on products
•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 project teams
•Manages large amount of complex information and make timely and effective decisions for the execution of project objectives
•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

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS:
•Ongoing collaboration with other departments such as QA, QC, R&D, MSO
•Participate in the weekly RA and project team meetings

EXTERNAL INTERACTIONS:
•Regular contact with Ministry of Health, FDA, EMA, Health Canada, ROW affiliates

Location: נס ציונה