Senior Regulatory Officer, Contract

Dublin  ‐ Onsite
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Keywords

Description

Generalist responsibilities encompass the support of worldwide product registrations and support of Regulatory activities including but not limited to:

  • Prepares, submits and maintains regulatory filings with relevant health authorities.
  • Prepares, submits and maintains product specific dossiers per local country requirements
  • Participates in new product development core teams and creates Regulatory Strategies
  • Maintains country specific site registration requirements
  • Under limited direction, prepares documentation for product incident reporting as required.
  • Reviews product labeling as required
  • Maintains regulatory knowledge of current guidelines and regulations
  • Maintains current regulatory knowledge by attendance at regulatory seminars and meetings
  • Maintains current regulatory databases and produce various reports as needed
  • Utilize and support electronic document management system
  • Responds to inquiries from health authorities.
  • Reviews and assesses regulatory impact associated with changes made at the manufacturing facilities for multiple regions.
  • Provides training and support to colleagues as needed


MINIMUM REQUIREMENTS :
Education required: Bachelor's Degree required, preferably in scientific or related discipline.
Experience : A minimum of 5 years experience required in Regulatory Affairs.

  • Experience in managing submission compilation and cross functional review required.
  • Experience with various international Pharmaceutical Drug regulations.
  • Experience with CMC and life cycle management
  • Demonstrated knowledge of ICH and GMP requirements.
  • Demonstrated ability to manage and track deliverables.
  • Ability to facilitate decision making.
  • Preferred Regional Asia Pacific and/or Latin America Knowledge
  • Skills/Competencies:
    Strong organizational skills
  • Ability to prioritize
  • Ability to problem solve
  • Ability to work well with others
  • Team oriented
  • Strong background using Microsoft Office tools and Adobe Acrobat
  • Excellent written and oral communication skills
  • Ability to facilitate decision making on specific content where expertise may reside with team members. Strong evidence and mastery of being Team Contributor Attention to detail and overall drug application quality and internal consistency Strong Decision Making Skills


Other Skills:
  • Ability to operate independently under limited supervision
  • Strong interpersonal, and negotiation skills, conflict management, priority setting, strategic agility, building effective teams, managing vision and purpose
  • Experience interacting with Health Care Professionals, affiliates and contractors worldwide
Start date
02/2015
Duration
6 months
From
Real Staffing
Published at
23.12.2014
Project ID:
826680
Contract type
Freelance
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