At a Glance
- Tasks: Lead regulatory activities for international markets and support product expansions.
- Company: Join a dynamic pharmaceutical company focused on global growth.
- Benefits: Permanent role with hybrid working, competitive salary, and career development opportunities.
- 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 affairs required.
- Other info: Collaborative team environment with opportunities for professional growth.
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 country-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 MAAs, 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 prioritise 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 Slough 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 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 brushing up on your knowledge of international regulations and recent changes in the EMEA region. We want you to be the go-to expert in the room, so show off your skills and experience!
✨Tip Number 3
Don’t forget to tailor your approach! When applying through our website, make sure your application highlights your specific experience with new marketing authorisation applications and lifecycle management. We love seeing how you fit the role!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind. Share a relevant insight or question about the role to show your enthusiasm and commitment to joining the team.
We think you need these skills to ace Senior Manager Global Regulatory Affairs in Slough
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Senior Manager Global Regulatory Affairs. 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 regulatory affairs, especially in international markets, 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 the role. We can’t wait to see what you bring to the table!
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 the submission processes for new marketing authorisation applications and lifecycle management activities, as these will likely come up in your interview.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed new MAAs or supported global expansion efforts. Highlight your experience with dossier remediation and how you've contributed to regulatory compliance in previous positions. This will demonstrate your hands-on expertise.
✨Be Ready to Discuss Collaboration
Since this role involves liaising with local Regulatory Affairs teams, be prepared to talk about how you've worked collaboratively in the past. Share instances where you’ve supported cross-functional teams and how you’ve navigated challenges in a team environment.
✨Demonstrate Your Strategic Thinking
Think about how you can contribute to the strategic development of the Regulatory Affairs function. Be ready to discuss your ideas on improving processes or supporting commercial development in international markets. This shows that you're not just focused on the day-to-day tasks but also on the bigger picture.