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- Tasks: Lead regulatory activities for international markets and support product expansions.
- Company: Join a leading international pharmaceutical company with a focus on innovation.
- Benefits: Permanent role with hybrid working, competitive salary, and career growth opportunities.
- Why this job: Make a significant impact in global healthcare by managing regulatory affairs.
- Qualifications: Degree in life sciences and 5+ years of regulatory experience required.
- Other info: Collaborative team environment with a focus on 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 EXPÉRIMENTÉ (H/F) in Slough employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land SENIOR MANAGER EXPÉRIMENTÉ (H/F) in Slough
✨Network Like a Pro
Get out there and connect with people in the industry! Attend events, join online forums, and don’t be shy about reaching out to professionals on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can land you that dream job.
✨Ace the Interview
Prepare for your interviews by researching the company and understanding their products and markets. We recommend practising common interview questions and even doing mock interviews with friends. Show them you’re not just a fit for the role, but also a great addition to their team!
✨Follow Up
After your interview, don’t forget to send a thank-you email! It’s a simple gesture that shows your appreciation and keeps you fresh in their minds. We believe this can make a big difference in how they perceive you as a candidate.
✨Apply Through Our Website
When you find a role that excites you, apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we’re always looking for passionate individuals to join our team, so don’t hesitate!
We think you need these skills to ace SENIOR MANAGER EXPÉRIMENTÉ (H/F) 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 international markets and any specific projects that align with the job description. We want to see how your background fits perfectly with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your skills can contribute to our team. Be sure to mention your experience with new marketing authorisations and lifecycle management.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use metrics or specific examples to demonstrate how you’ve successfully managed projects or contributed to global expansions in your previous roles. We love seeing results!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
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 experienced but also proactive in your field.
✨Showcase Your Project Management Skills
Since the role involves managing multiple projects and deadlines, prepare examples of how you've successfully juggled various tasks in the past. Use the STAR method (Situation, Task, Action, Result) to structure your responses and highlight your ability to prioritise effectively.
✨Collaborate Like a Pro
This position requires liaising with local Regulatory Affairs teams and cross-functional groups. Be ready to share experiences where you've worked collaboratively, showcasing your communication skills and ability to work well in a team environment.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory strategies and future plans for international expansion. 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.
