Regulatory Affairs Officer

Posted 17 September by Blue Pelican
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If you’ve got a solid grounding in Regulatory Affairs gained in a UK or Ireland focused role and you’re interested in your next career move I’d love to talk with you about an opportunity I’m handling with a genuinely great company

I’m working with a UK headquartered global pharma / medical device company.  Well established and with a niche product portfolio they’re actively investing in their regulatory affairs function  The aim is develop regulatory as a function so that they are a more strategic, forward thinking and value added part of  the business.  They’re looking for people who want to grow with the business as they revitalise the regulatory team as a key partner in the business.

The company is catering to a patient population with unmet needs and has products that truly make a difference.  I can speak really highly of the business itself but it’s the people there that really make this such a fantastic opportunity.  There’s a really consistent culture there as they employ according to type.  They’re positive, high calibre, high energy and importantly genuinely decent, likable and fun.  There’s also a strong  focus on wellbeing and it’s an incredibly supportive culture.

The main purpose of this role is to prepare and submit right-first-time MAs and variations ensuring compliance is kept at the heart of all they do.

Typical responsibilities of the role include, but aren’t limited to

  • Compiling and submitting variations and renewals to relevant authorities (MHRA and HPRA) under the guidance of the head of regulatory.
  • Working closely with partners across a wide geographic area to ensure the same for their countries.
  • Working cross functionally with colleagues in other teams to ensure regulatory compliance is consistent throughout the supply chain (mainly but not limited to QA).
  • Proactively identifying problems and ensuring that they’re addressed effectively and efficiently.

I’m not looking for someone with many years experience for this role. I do have some key, non negotiable requirements though

  • You’ll have a solid background (expected to be circa 2- 3 years experience) in post marketing regulatory affairs.
  • You’ll have specific experience of having worked in UK / Ireland organisations.
  • You’ll have demonstrable competencies in working effectively with partners, suppliers and cross functionally with colleagues.

As important as your actual skills and experiences are it’s equally important that you’re a good fit for the organisation. 

You’ll have a high energy, proactive and positive personality.  Optimistic and ‘can-do’

You’ll have a good balance of collaboration and diplomacy and will recognise the best approach to working with people to achieve great results.

You’d be joining an existing team with a great manager. She’s a real people person with a commitment to her team and a desire to achieve great results while creating a pleasant environment that people enjoy.  There are specific opportunities for skill and career development as well as a strong, rounded remuneration package.

Reference: 40894097

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