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Regulatory Affairs Project Manager

Employer
Thornshaw Recruitment
Location
Dublin (County), Leinster (IE)
Salary
Negotiable depending on experience
Start date
16 Mar 2023
Closing date
29 Mar 2023

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Job Details

My client, a global pharmaceutical company in Southwest Dublin, is currently recruiting for a Regulatory Affairs Project Manager to join their team.

 

This is a maternity contract (13 months) and will report to the Head of Regulatory Affairs Europe.

 

Hybrid working available (2 days onsite)

 

 

 

Job 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.

 

 

Essential Experience & Education Required

  • 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. The person must have EU regulatory submission experience and submissions with generic pharmaceutical products Proficient English skills Results and performance driven – deliver results that meet or exceed expectations Accountability and ownership – deciding and initiating actions

 

 

If you are interested in applying for this role or discuss the position in more detail, please call Zoe on +353 1 2784671 or email zhamilton@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part 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
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