Connecting to LinkedIn...

Regulatory Affairs Specialist - Operations

Job Title: Regulatory Affairs Specialist - Operations
Contract Type: Permanent
Location: Dublin
Industry:
REF: 123663
Contact Name: Laurentina Kennedy
Contact Email: laurentina@rftgroup.ie
Job Published: 11 months ago

Job Description

Regulatory Affairs Specialist - Perm - Dublin 
The Regulatory Affairs Specialist -Operations will be responsible for overseeing operational aspects of all regulatory submissions, ensuring that the submissions are of the highest quality, delivered on-time, and within the established budget. The position is also responsible for overseeing the effective and appropriate management of regulatory documentation.

REPORTING TO: RA Manager
DUTIES:
  • Manage document publishing for regulatory submissions from all areas of a company, in support of global regulatory submissions which may include both paper and e-filings
  • Manage publishing activities for marketing applications in eCTD format; formatting, publishing, submitting, lifecycle activist, and archiving sequences
  • Oversee the management of electronic and/or paper-based regulatory records
  • Provide recommendations on resource needs for regulatory operations and records management activities including the need for outsourcing (e.g., eCTD vendor, SPL vendor)
  • Provide oversight for the selection and management of any outsourced publishing and records management vendors
  • Create and manage submission plans, in conjunction with Regulatory colleagues
  • Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities
  • Manage selection, implementation, validation (as applicable) and maintenance of IT tools for regulatory team
  • Develop proposals for continuous improvement of internal systems and processes related to publication, submissions, and archiving of regulatory dossiers in a secure and readily accessible manner
  • Apply knowledge of electronic publishing requirements to ensure compliance with agency submission requirements and remain current with evolving standards for electronic submissions and inform other staff of these standards

QUALIFICATIONS:
Bachelor's degree with a minimum of 5 years’ experience in a Regulatory Operations role.
Ability to work independently with moderate supervision.
Ability to communicate and interact with a variety of personnel, including management and external vendors.
Ability to direct operational staff to achieve submission publishing timelines successfully.


CV's to Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
Follow us on Facebook, Linked-in, Twitter