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Regulatory Affairs Specialist

Employer
i-Pharm Consulting
Location
Dublin, Republic of Ireland
Salary
Negotiable
Start date
14 Jul 2021
Closing date
28 Jul 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Regulatory Affairs Specialist

Leading Pharmaceutical company

6 month contract

Dublin, Ireland

Full time work - 40 hours per week

JOB DESCRIPTION

Position Overview

  • For assigned products and under supervision of Assoc. Director ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities and - as applicable - to the EMA.
  • For assigned products and under supervision of Assoc. Director ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, PSURs and supplemental marketing authorizations.
  • For assigned products ensures high quality labeling review and artwork management.
  • For assigned products and tasks, stays updated on relevant EU and local regulations and guidelines.
  • Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
  • Maintains a positive relationship with internal and external regulatory contacts. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
  • By discretion of Regulatory Affairs Management and due to organization and work load, all listed activities need not to be performed.

Major activities include, but are not limited to:

New MA applications for assigned products:

  • Under supervision, performs timely and correct submissions and approvals of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing, external affairs departments, as well as with local regulatory authorities as appropriate, depending on procedure type. Tracks process on products registration and major new indications.

Maintenance of licenses for assigned products:

  • Under supervision, ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicate approvals to stakeholders through the correct processes.

Compliance:

  • For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, packaging material and other applicable regulatory documents according to local standards and relevant Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
  • Ensures the correct and proper utilization of AMS to generate mockup artwork and to implement revisions to artwork.
  • Ensures that files and archives related to Regulatory are kept updated and complete.
  • Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.

Artwork:

  • Prepares artwork, including package leaflets and all other components in a timely and correct manner and according to relevant Artwork Management procedures.
  • The incumbent ensures proof reading of packaging components and is responsible for maintaining an updated file on packaging components, as applicable.

Regulatory environment:

  • Keeps abreast of local and international laws.
  • Through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with interests.
  • Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders, and in concurrence with the EU Regulatory Policy lead.
  • Participates in internal European regulatory workgroups on selected issues.

Skills Required:

Must be at least B.Sc in pharmacy or other life science.

A minimum of 2 years experience in the pharmaceutical Industry is preferable, in a regulatory, medical or laboratory position.

Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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