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- Tasks: Lead regulatory activities for international markets and support product expansions.
- Company: Join a leading pharmaceutical company with a focus on global growth.
- Benefits: Permanent role with hybrid working options and career development opportunities.
- Why this job: Make a significant impact in the pharmaceutical industry while working on exciting global projects.
- Qualifications: Degree in life sciences and 5+ years of regulatory experience required.
- Other info: Collaborative team environment with a focus on innovation and strategic development.
The predicted salary is between 48000 - 72000 £ per year.
Blackfield Associates are proudly partnered with an international pharmaceutical client on an exclusive basis, who are looking to establish a new team for their international and emerging markets division. We’re looking for an experienced Regulatory Manager to execute activities across international markets and EMEA. This includes submission and maintenance of new products, both generic and speciality, as well as supporting the global expansion of existing products.
As Regulatory Affairs Manager, you will:
- Preparation and submission of new marketing authorisation applications, supporting international countries within the EMEA region
- Preparation and submission of registrations for existing products as part of global expansion activities
- Lead dossier remediation activities, such as aligning older registrations with current regulatory requirements in support of geographic expansion
- Support lifecycle management activities for marketed products, including Variations, Renewals and PSURs
- Liaise with local Regulatory Affairs staff on regulatory documentation, including labelling, variations, and new registrations
- Support local Regulatory Affairs teams with countries-specific labelling activities
- Track registrations using relevant regulatory databases and tracking systems
- Maintain regulatory archives, including dossiers, documents, and media
- Provide regulatory support to cross‑functional teams (portfolio management, out‑licensing, launch management)
- Proactively contribute to the strategic development of the Regulatory Affairs function and support the successful commercial development of international markets within the EMEA region
To be considered for the role of Regulatory Affairs Manager, you will have:
- Educated to degree level in relevant life sciences studies
- Minimum 5 years’ experience supporting international markets
- Previous experience managing New MAA’s, Global expansion of existing products and extensive lifecycle maintenance is essential
- Experience working closely with international Regulatory Affairs affiliates
- Strong ability to manage deadlines and priorities multiple projects simultaneously
- Ability to work independently and collaboratively within a team environment
This is a permanent, full-time role. Located at the affiliate office, you will need to be able to attend the Slough office on a hybrid basis. Unable to sponsor, candidates must have full right to work in the UK and flexibility around working hours due to territories.
Senior Manager M/F/D in Slough employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager M/F/D in Slough
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in regulatory affairs. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Show them you know their stuff! Tailor your answers to highlight how your experience aligns with their needs, especially in international markets.
✨Tip Number 3
Don’t just wait for job alerts! Actively search for roles on our website and apply directly. The more proactive you are, the better your chances of landing that Senior Manager role.
✨Tip Number 4
Follow up after interviews with a thank-you email. It’s a simple gesture that shows your enthusiasm for the role and keeps you fresh in their minds. Plus, it’s a great way to reiterate your fit for the position!
We think you need these skills to ace Senior Manager M/F/D in Slough
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Regulatory Affairs Manager. Highlight your experience with marketing authorisation applications and global expansion activities, as these are key aspects of the job.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your past experiences in managing MAAs and lifecycle maintenance to show how you can contribute to our team.
Showcase Your Team Spirit: We love collaboration! Make sure to mention any experiences where you've worked closely with cross-functional teams or local Regulatory Affairs staff. This will demonstrate your ability to thrive in a team environment.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity in our international markets division.
How to prepare for a job interview at Blackfield Associates
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to international markets, especially within the EMEA region. Being able to discuss recent changes or trends in regulatory affairs will show that you're not just knowledgeable but also passionate about the field.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed new marketing authorisation applications or supported global expansions. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements.
✨Demonstrate Team Collaboration
Since this role involves liaising with local Regulatory Affairs teams, be ready to discuss how you've worked collaboratively in the past. Share instances where you’ve contributed to cross-functional projects and how you’ve navigated challenges with team members.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s regulatory strategies and future plans for international markets. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your career goals.
