Continuum India Hiring Regulatory Affairs Specialist – EMEA

Continuum India Hiring Regulatory Affairs Specialist – EMEA

22 April, 2022

Job Overview

Responsible for regulatory activities and implementation of regulatory strategies in compliance with applicable global regulations. This position requires a strong team player who can work across various cultures and various departments.

Functional Responsibilities

Delivery

  • Creates, reviews, and maintains regulatory documents and submissions to regulatory agencies (e.g., Technical Documentation/CPSR, Product Information File, Safety Assessments) and other regulatory files/documents in compliance with the company procedures and applicable regulations
  • Prepares and maintains necessary outlines, summaries, status reports, memos, graphs, charts, tables, and presentations
  • Works closely with internal and external teams to collect and coordinate information and regulatory documentation for new or maintenance of existing regulatory submissions/files
  • Effectively communicates and provides regulatory support and guidance to various cross-functional teams
  • Interacts closely and maintains productive relationships with external customers, in-country regulatory representatives and notified-bodies as required
  • Supports requests for product regulatory information and provides relevant information
  • Maintains various tracking tools to ensure up to date information and traceability of assigned tasks
  • Provides solutions to a variety of problems of moderate scope of complexity
  • Effectively communicates business related issues or opportunities to appropriate teams/personnel
  • Ensures compliance with current good documentation practices including but not limited to document creation, proof reading, formatting, indexing, and record keeping

Training compliance

Ensure that all trainings (internal training and client training) are successfully completed in a timely manner by each team member

Education

B. Pharma/BS Degree, and/or advanced degree in a health or life science related field

Skills and personal attributes

  • Proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint) is required.
  • Good experience and technical skills within Regulatory Operations
  • Ability to directly oversee and lead projects and people in a matrix environment
  • Excellent relationship building, people management and communication skills
  • Integrity, credibility, and commitment to building the CONTINUUM brand in the marketplace
  • Demonstrates the ability to use knowledge and experience to understand financial and industry data to make decisions

Minimum Work Experience

More than 03 years of regulatory affairs experience is required. Working knowledge of EU/UK/Global Cosmetic Regulations is highly preferred. Project management skills and experience preferred. Detail oriented with strong organizational, analytical, and critical thinking skills. Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision.

Apply through this Link

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