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Regulatory Affairs Project Manager

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Start date
17 Feb 2021
Closing date
19 Mar 2021

View more

Discipline
Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

On behalf of my client, a global Pharmaceutical company with offices in Dublin we are working with them on the recruitment of a Regulatory Affairs Project Manager.  This is a permanent role.

Key Responsibilities.

  • Management and coordination of regulatory operations for regulatory submission team with decentralised set up
  • Representing regulatory submission function in the projects related to the operational changes, technical projects or the projects driven by PV department
  • Compile country specific regulatory intelligence from Regulatory Affairs Managers responsible for regulatory submission activities in all EU CIS territories and provide the consolidated intel on the Regulatory Plan to the stakeholders from other departments – Pharmacovigilance, Regulatory Compliance, Global Regulatory
  • Provide support in respect to registration strategy (assist in development of regulatory strategy) as well as monitoring the impact of changing regulatory environment on submission strategies
  • Introduction of the new projects to regulatory submission team
  • Communicate of the project status to the local affiliates in scope of the project via regular meetings
  • Coordinate with regulatory submission team the planned submissions ensuring that expectations and objectives are shared on time, documentation required for the submission provided and submission timelines are met
  • Plan and monitor of submission date per market ensuring that registration deadlines are met, track submission progress through efficient communication to relevant stakeholders and Regulatory Service Providers (RSPs) and communicate any change in status or delays
  • Proactively inform the Head of RA (Europe) and other involved business units regarding all identified risks related to the planned MA applications
  • Coordinate with Regulatory Compliance the preparation of responses to Request for Information (RFI) received from Health Authorities to achieve the harmonised registered data across the countries
  • Manage the Commitment Tracker
  • Support / Coordinate the data needed to make all required registration fees in a timely manner
  • Liaise with other departments to support the timely introduction of new products into markets
  • Assess the impact on existing registered documentation when new regulatory requirements are issued
  • Perform assigned tasks to the highest standard and in accordance with established internal timelines and guidelines.
  • Ensure information exchange and periodic reporting to the Head of RA (Europe) – updating and maintaining regulatory submission and RFI tracker on a weekly basis
  • Monitor planned approval timelines and if necessary, intervene to facilitate approval and minimise registration delays
  • Raise change controls and provide regulatory assessment, strategy, and regulatory impact assessment for change controls
  • Manage the regulatory intelligence updates for the region

 

 

Education/Requirements:

  • High level education such as BSc, MSc, PhD or Pharmacist in Life sciences or related area
  • At least 3-5 years in a similar role in Regulatory in the pharmaceutical industry

Proficient English skills

  • Positive ‘can – do’ attitude
  • Be able to work autonomously and have good problem-solving skills
  • Able to cope with evolving deadlines effectively with regular feedback and updates.
  • Honest and trustworthy
  • Act with integrity
  • Respectful and highly personable
  • Possess cultural awareness and sensitivity
  • Flexibility & Confidentiality are key requirements for this role.

Contact Tina for full job spec on +353 1 2784701 or email tdunne@thornshaw.com

Thornshaw is a division of the CPL group   www.thornshaw.com

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

thornshaw-ourmission

For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

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