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- Tasks: Lead regulatory activities for international markets and support product expansions.
- Company: Join a global pharmaceutical leader with a focus on innovation.
- Benefits: Permanent role with hybrid working, competitive salary, and career growth.
- Why this job: Make a real impact in global healthcare by managing regulatory affairs.
- Qualifications: Degree in life sciences and 5+ years in international regulatory experience.
- Other info: Collaborative team environment with opportunities for professional 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 Global Regulatory Affairs in Reading employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Global Regulatory Affairs in Reading
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in regulatory affairs. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of international regulations and recent changes in the EMEA region. We want you to be able to discuss how your experience aligns with the role and demonstrate your expertise confidently.
✨Tip Number 3
Showcase your achievements! When discussing your past roles, highlight specific projects where you successfully managed submissions or expansions. Use metrics to back up your claims – numbers speak volumes!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace Senior Manager Global Regulatory Affairs in Reading
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 for us.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this position. Share specific examples of your past successes in regulatory affairs, especially in international markets.
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. It’s all about teamwork in this role.
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.
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. Familiarise yourself with recent changes in regulatory affairs that could impact the role, as this will show your commitment and expertise.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed new marketing authorisation applications or supported global expansion activities. Use the STAR method (Situation, Task, Action, Result) to structure your responses and highlight your achievements.
✨Demonstrate Team Collaboration
Since the 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 supported cross-functional teams and how your contributions led to successful outcomes.
✨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 helps you gauge if the company aligns with your career goals.
