Director – Regulatory Affairs and PV

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About the job

Do you have several years of relevant regulatory industry experience? Do you want to join a fast-growing global pharmaceutical company? 

Invenia Group is partnered with a global pharmaceutical business, searching for a Director of Regulatory Affairs and PV. This is a fantastic opportunity to join one of the fastest-growing pharmaceutical companies in the world, where you can be a part of a forward-thinking team of professionals and join a dynamic team and company.

Roles and responsibilities:

If successful, you will maintain and develop a strong relationship with HPRA, answering any requests promptly regarding the information on the benefits and risks of pharma products. You will work as the oversight of RA and PV groups in the Ireland division, and oversee all risk minimization measures for Ireland as well as the following: 

  • Play a key role in UK and Ireland RA Leadership team
  • Support the Irish quality function and the Irish PLRP
  • Ensuring new product approvals are received and communicated in line with commercial requirements
  • Ensuring Marketing Authorisations are maintained
  • Overseeing all Risk Minimisation activities specifically any Pregnancy Prevention Programmes required to allow the marketing of medicines
  • Management of the Irish regulatory budget
  • Oversee implementation of RIMS in Ireland
  • With the UK regulatory leaders investigate efficiencies and pooling of activities across the cluster

What we are looking for:

We are looking for someone with several years of relevant regulatory industry experience. You should be a life science graduate or pharmacist/physician, with strong communication skills, both externally and internally. Membership of relevant professional bodies is not essential but would be a good bonus (such as Regulatory Affairs Association, BrAPP).

If you are interested in proceeding with this opportunity, please apply so we can arrange a confidential discussion to discuss the position in more detail.