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.
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