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- 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 leadership role with a chance to shape a new department.
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 team, 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 the EU.
The successful candidate will be an agile, autonomous leader, who wishes to be hands-on and grow a new department. This is a permanent, full-time role. Based from the company's 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 in Slough employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Global Regulatory Affairs in Slough
✨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 referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulations and trends. We want you to showcase your expertise in regulatory submissions and lifecycle management, so be ready to discuss your past experiences in detail.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website! We’ve got a streamlined process that makes it easy for you to submit your application. Plus, it shows you’re serious about joining our team and helps us keep track of your application.
We think you need these skills to ace Director Global Regulatory Affairs in Slough
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 roles, especially in emerging markets. 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 achievements in regulatory affairs and how you can lead our new team to success.
Showcase Your Global Experience: Since we're looking for someone with international experience, make sure to emphasise any work you've done in Latin America and Asia. We want to know how you've navigated different regulatory landscapes and what strategies you've used.
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. Plus, it shows you’re keen on joining our team at StudySmarter!
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 APAC. Being able to discuss specific regulatory challenges and how you've navigated them in the past will show your expertise and readiness for the role.
✨Showcase Your Leadership Skills
As a Regulatory Affairs Director, you'll be leading a small team. Prepare examples of how you've successfully led teams in the past, particularly in high-pressure situations. Highlight your ability to provide strategic guidance and support to your team while ensuring compliance with regulatory requirements.
✨Understand the Company’s Portfolio
Familiarise yourself with the company's products and their current status in various markets. Be ready to discuss how you would approach the lifecycle management and global expansion of these assets. This shows that you're not just interested in the role but also invested in the company's success.
✨Prepare Questions for Them
Interviews are a two-way street! Prepare insightful questions about the company’s regulatory strategies, team dynamics, and future goals. This not only demonstrates your interest but also helps you gauge if the company is the right fit for you.
