Browse by job sector

Principle Registration Officer

  1. London
London
  1. Permanent
Competitive
  1. CAPEX Projects
32366
Apply to this job Save job
Principle Registration Officer - Life Science - London 

Are you looking for the opportunity to work alongside a global pharmaceutical organisation in Ireland’s picturesque capital? Our esteemed client is looking for a Reg Officer  to join their team in their existing manufacturing facility in North Dublin.

The facility is a responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for a Reg Officer to help maintain manufacturing operations.


Responsibilities: 
  • Obtain and maintain generic and branded marketing authorisations for designated EU and non-EU territories (through internal and Third Party workstreams) to ensure on-time launches, continued supply and the compliance of all products.
  • Manage & coordinate the DCP / MRP process, including leading launch meetings, estimating product approval times, liaising directly with Agencies as Subject Matter Expert.
  • Ensure databases and systems are maintained in accordance with current SOPs to fulfil regulatory obligations.
  • Advise Senior management of the status and progress of assigned projects to meet departmental and regional objectives and timelines; identifying potential problems or delays, and possible solutions, as they occur.
  • Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities).
  • Provide expertise and specialist knowledge to support the department. Provide mentoring and training to department in specialist areas, as required.
  • Attend and contribute at Principal Registration Officer meetings; proactively raise issues and collaborate effectively to propose solutions. Ensure company/regulatory decisions are disseminated to junior team members.

Requirements: 
  • BSc in Life sciences or higher-level qualifications.
  • Extensive and proven experience in EU Regulatory Affairs (SME – Subject Matter Expert)
  • Must have 5+yrs experience of full lifecycle of existing or new product registrations including strategy/planning, registrations, monitoring, post marketing approvals, through to launching in accordance with EU regulations.
  • In-depth understanding of DCP / MRP processes, and able to give examples of estimating approval times and technical questions around variations and submissions.
  • Effective verbal and written communication skills.
  • Proven experience in managing large volume and fast paced product portfolios.
  • Flexible approach to enable prioritisation in line with company requirements.
  • Previous experience in mentoring junior team members of staff including SROs & ROs.

If this role is of interest to you, please apply now! 

 #LI-KT1
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Maintenance / Project engineer

Salary

Competitive

Location

Bedford

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

East Anglia

Description

Maintenance / Project Engineer -  Life Sciences - Bedford - 6-Months  How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes,

Reference

35167

Expiry Date

01/01/0001

Bobby Andrews

Author

Bobby Andrews
Bobby Andrews

Author

Bobby Andrews
Read more
Read more
Procurement

Salary

Competitive

Location

San Juan

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Argentina

Description

Procurement - Pharmaceuticals - San Juan - 12-Month Contract  This is a fantastic opportunity for a Procurement to join our major, global pharmaceutical client on their latest new-build project

Reference

35286

Expiry Date

01/01/0001

Kristen Scott

Author

Kristen Scott
Kristen Scott

Author

Kristen Scott
Read more
Read more
Quality Engineer

Salary

Competitive

Location

County Mayo

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Midlands (Ireland)

Description

Quality Engineer - Westport, County Mayo Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for Quality Engineerto join their state of the art

Reference

34865

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more

Insights

life sciences testing laboratory

Why you should work in Commissioning, Qualification and Validation
Read more

02/07/2023

Your next step as a Validation Engineer
Read more

07/20/2021

pharmaceutical factory construction

Working in an organisation from Start Up Phase

Read more

06/28/2021

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV