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Job Details

Regulatory Affairs Manager

Company: Validant
Location:
Reference: RA Med Device
Closing Date: 03 Feb 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Validant requires a Russian speaking Medical Device Regulatory Affairs Manager to participate on a global project based in Russia.

Requirements:

About Us:

Validant is a leading global life-sciences firm specialising in Quality, Manufacturing, Regulatory, Engineering, and R&D services. We blend the best of Consulting and Professional services, Industry and Regulatory leaders, Thought leaders and Tactical support, to create tailored solutions.

These include strategic consulting, program leadership, on-demand expertise, managed solutions, execution level resources, FDA & EMA Compliance, Remediation, Validation & Regulatory Submissions and Project Management.

Overview

Project: Senior Regulatory Affairs Manager (Hands-on) – Medical Devices

Reporting: Directly to Regulatory Affairs Director

Location: Russia (on-site)

Start: ASAP

LOA: 6 months+ Extensions. Client would like an option to hire after initial contract.

Validant are looking for candidates who can manage the level of complexity and interaction within a large multinational and the numerous licenses and projects they have. There are numerous projects at the same time with multiple licenses for this transformation so they need some level of experience in project management and complex work to manage.

Due to changes in regulations, Russian 2013 GOST Standards is necessary.

Duties/Responsibilities

  • Manage the regulatory team of ~5 people.
  • Ensures compliance with regulatory agency regulations and interpretations
  • Prepares responses to regulatory agencies' questions and other correspondence
  • Organizes and maintains reporting schedules for new drug application and investigational new drug applications
  • Prepares necessary outputs, including outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
  • Provides solutions to a variety of problems of moderate scope or complexity
  • Conducts searches of existing files for requested information
  • Maintains and archives all regulatory documentation

Education and Experience Qualifications

  • 10+ years’ experience minimum
  • Strong and proven leadership capabilities.
  • Project Management certifications preferred.
  • Must have knowledge and experience of Russian regulations and systems and 2013 GOST Standards;
  • Experience with Eurasian Economic Union (EAEU) registration
  • Labelling experience.
  • Minimum of a B.A. /B.S. within a technical related discipline is required. 
  • Ability to work both independently and in a team environment. Ability to problem solve, recognize and find solutions for gaps in processes. 

Apply for this job: Regulatory Affairs Manager

Contact Information:

Address:  Cork
Unit 4 Emmett House Barrack Square Ballincollig Cork

Rep. Ireland

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