Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead a new team in regulatory affairs for global pharmaceutical expansion.
- Company: Join an international pharmaceutical client with a focus on emerging markets.
- Benefits: Permanent role with hybrid working and opportunities for career growth.
- Why this job: Make a significant impact in global regulatory strategies and product lifecycle management.
- Qualifications: 10+ years of regulatory experience, especially in Latin America and Asia.
- Other info: Dynamic role requiring leadership and strategic guidance in a fast-paced environment.
The predicted salary is between 72000 - 108000 £ 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 emerging markets division. To lead this team, we’re looking to hire a Regulatory Director to ensure successful registration, lifecycle management and global expansion of the portfolio, while providing leadership to a small team and working closely with affiliates and international stakeholders.
As Regulatory Affairs Director, you will:
- Lead and oversee a new, small RA international teams, providing leadership and regulatory strategic guidance ensuring successful and timely regulatory submissions.
- Lead the preparation, submission, and approval of regulatory filings (new product registrations, existing product global expansion registrations, variations and other lifecycle regulatory activities) for the companies identified international markets with a portfolio of assets.
- Manage existing product dossier updating and remediation activities supporting global expansion of existing products into new markets- emerging markets/ LATAM and JPAC.
- Liaise with country affiliate and distributor RA teams providing support for regulatory submissions, labelling and post approval submissions, and ensuring regulatory compliance.
- Provide updates to senior leadership on regulatory submission activities as needed.
- Analyse evolving global regulations, trends, and competitive landscapes within the EMEA international region.
- Manage the product lifecycle, including Marketing Authorization submissions, (DCPs, MRPs), set up and implement post-approval line-extension and variation strategies, maintenance activities.
To be considered for the role of Regulatory Affairs Director, you will:
- Be educated to degree or advanced degree in related life science field.
- Have significant Regulatory experience – 10 years plus – including strategic leadership and global experience in international markets.
- Have regulatory experience of Latin America and Asia countries which is essential.
- Have experience managing regulatory registrations for existing products for global expansion.
- Demonstrate proven success in the effective management of timely approval of regulatory procedures in emerging markets.
- Have a broad understanding of the requirements to place products on the market within EU.
The successful candidate will be an agile, autonomous and a leader, who wishes to be hands on and grow a new department. This is a permanent, full time role. Based from the companies affiliate office, you will need to be able to attend the Slough office on a hybrid basis. Unable to sponsor, candidate must have full right to work in the UK and flexibility around working hours due to territories.
Director Global Regulatory Affairs employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Global Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who have experience in regulatory affairs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulations and trends. Be ready to discuss how your experience aligns with the needs of the role, especially in emerging markets like LATAM and JPAC.
✨Tip Number 3
Showcase your leadership skills! During interviews, share examples of how you've successfully led teams and managed regulatory submissions. Highlight your strategic thinking and ability to navigate complex regulatory landscapes.
✨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 are proactive and engaged in their job search.
We think you need these skills to ace Director Global Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Regulatory Affairs Director. Highlight your relevant experience in regulatory submissions and leadership in international markets, especially in LATAM and JPAC. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Share specific examples of your success in managing regulatory registrations and leading teams. We love a good story that showcases your skills!
Showcase Your Global Experience: Since this role involves working across various international markets, make sure to highlight your global regulatory experience. Discuss any challenges you've faced and how you navigated them. We’re keen to see your understanding of different regulatory landscapes!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates. Plus, we love seeing applications come in through our own channels!
How to prepare for a job interview at Blackfield Associates
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and trends in the pharmaceutical industry, especially in emerging markets like LATAM and JPAC. Being able to discuss specific examples of your past regulatory successes will show that you’re not just knowledgeable but also experienced.
✨Show Leadership Skills
As a Regulatory Affairs Director, you'll be leading a small team. Prepare to share your leadership style and how you've successfully guided teams in the past. Think of specific instances where your strategic guidance led to successful regulatory submissions or product launches.
✨Understand the Company’s Portfolio
Familiarise yourself with the company’s existing products and their regulatory status. This will help you speak confidently about how you can contribute to their global expansion efforts and manage lifecycle activities effectively.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or changes in legislation. Practise articulating your thought process and decision-making strategies, as this will demonstrate your ability to navigate complex regulatory landscapes.
