Regulatory Affairs Manager

County Kilkenny
Dependent on experience
17 Oct 2019
14 Nov 2019
Georgina Hillier
Contract Type
Full Time
We are currently looking for a Regulatory Affairs Manager to join a leading pharmaceutical company with a global focus, based in Southern Ireland. As the Regulatory Affairs Manager you will be responsible for the line management of the regulatory affairs team where they will be focusing on the registration of generic pharmaceutical products to global markets.

This position would suit someone looking to join a growing global pharmaceutical company with a start up feel, where you'll have the opportunity to work closely with the Head of Scientific Affairs.


Your duties as the Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:

1. You will support the Head of Scientific Affairs to plan regulatory projects, including tasks and resources required for registration of products in worldwide markets including EU, US, LATAM and APAC. In addition, you will be supporting the Clinical Affairs team with Regulatory approvals including clinical trial applications, INDs and bioequivalency studies.

2. You will ensure regulatory compliance by overseeing licensing activity for existing Global marketing authorisation applications and providing licence maintenance support for clients.

3. You will manage strategic planning and submissions to target markets, including liaising with internal departments e.g. R&D, QC and production, and external experts where required, to agreed time lines.

4. You will be a strong leader. Coaching and supporting members of the team with problem solving and skill development. In being a manager you will be responsible for department budgeting and controlling spending in-line with annual budgets.


To be successful in your application to this exciting opportunity as the Regulatory Affairs Manager we are looking to identify the following on your profile and past history:

1. Relevant degree in a a life science, including but not limited to: Chemistry, Pharmacy, Pharmacology in addition to extensive regulatory experience.

2. Proven industry experience in licensing pharmaceutical products to a range of markets, in addition to previous experience in people management.

3. A working knowledge and practical experience in cGMP regulations, Global regulatory approval process, analytical/formulation development of pharmaceutical products, and electronic document management systems.

Key Words: Regulatory Affairs | Management | Licensing | Applications | Compliance | Strategic Planning | EDMS | cGMP | Electronic document management system | Pharmaceuitcal | dossier | CMC | Clinical | IMP | clinical trial | human | Veterinary | budgets | Global | Worldwide | EU | LATAM | US | APAC | IND | bioequivalency |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.

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