Global Regulatory Affairs Associate
- Experience Level
- Experienced (non-manager)
Middlesex based with some flexibility for home working (1-2 days a week)
Salary £35,000 to £45,000
If you’re a solidly experienced regulatory affairs professional with some well established global (excluding USA) experience and you’d like to know about a really nice role with a fantastic manager and team it would be great to hear from you.
We’re working with a specialist, highly regarded global pharmaceutical company. They work with niche products and have a reputation for excellence both in terms of their products and their company.
The role we’re recruiting for sits in a small, portfolio aligned team in the global regulatory division. You’d be working alongside two other experienced reg affairs colleagues under the leadership of an absolutely great manager. His approach is a combination of supportive and empowering and he’s got a strong aversion to micromanagement.
The role includes what you’d consider to be core regulatory activities. These include but aren’t limited to
- Compilation of regulatory submission for new registrations
- Renewals, Variations and updates to patient and prescriber information and labelling
- Market authorisation transfers
- SOP development and creation as they pertain to Regulatory.
It’s important to note that this is an international team working globally (although not with the FDA / US). Its therefore really important to note that we’re looking for someone who has a solid existing level of experience working at that level. Regrettably our client can’t consider people who’ve only worked in the EU or at a limited local regional basis. Specifically we’re talking about Asia Pacific, Latin America, Europe (including Central and Eastern Europe) and Africa.
What’s on offer is an opportunity to work in a genuinely diverse role at a truly international level with some great products and as part of a great team. You’d also be working in a highly cross functional capacity so we’re looking for people who don’t want to work in a reg affairs bubble and who enjoy interacting with other parts of the business.
The company has a reputation for developing their people and have a in house training function that empowers people to grow their careers into different areas. That might be project management or a commercial or other aligned function. They’re also very focused on employee support and well being and have tangibly demonstrated this throughout the last year.
The big sell for me on this role is the manager. He’s a very experienced, well respected reg affairs leader who I’ve known for years. Incredibly strong technically and highly engaging and likable he’s the kind of person who’d make a great boss.
What I’m looking for in summary is;
Someone with 2-5 years experience with a broad, international reg affairs role with pharma products as well as good secondary competencies / understanding of GMP from a reg affairs perspective
A self starter who can effectively manage their own time and priorities.
If that sounds interesting I’d love to hear from you so that I can tell you more.