At a Glance
- Tasks: Lead regulatory submissions for exciting biopharma products in rare diseases.
- Company: Join a well-established global pharmaceutical company with a strong portfolio.
- Benefits: Enjoy a dynamic work environment and opportunities for professional growth.
- Other info: Contact Ethan Cortese at Apsida Life Science for more details.
- Why this job: Be part of a mission-driven team making a real impact in healthcare.
- Qualifications: Life science degree and 5 years of Regulatory Affairs experience required.
The predicted salary is between 48000 - 72000 £ per year.
Apsida are currently recruiting on behalf of a well-established, Global pharmaceutical company who are entering an exciting period with further expansion of their rare disease portfolio. We are searching for a Global Regulatory Affairs Manager who will be managing and implementing EU/US/ROW Regulatory strategies for a recently in licensed product. This organisation has gone from strength to strength and boasts a well-performing portfolio of products across multiple therapeutic areas, including rare diseases.
Responsibilities:
- This role will take the lead on the design and execution of certain sections of regulatory submissions such as variations, renewals and CTA applications.
- Manage post-approval submissions in approved territories (EU/US) as well as managing the submission process in ROW countries (in conjunction with CROs/Partners).
- Manage the submission of ongoing and new marketing authorisation applications in rest of world countries.
- For any new indications in development to be primarily involved in the preparation and submission support for clinical trial applications, scientific advice procedures, orphan designation requests and Paediatric Investigation Plans (PIPs).
Requirements:
- Life science related degree.
- Minimum of 5 years Regulatory Affairs experience, with working knowledge in EU and/or International markets.
- Experience of regulatory requirements for registering a new drug product in ROW countries.
- Previous experience in using the centralised procedure in the EU would be an advantage.
If you are interested in learning more, please reach out to Ethan Cortese at Apsida Life Science: Ethan.cortese@apsida.com
www.apsida.co.uk
+44 (0) 203 854 4606
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK) & Boston (USA) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.
Global Regulatory Affairs Manager – Biopharma in Watford employer: Apsida Life Science
Apsida Life Science is an exceptional employer, offering a dynamic work environment that fosters innovation and collaboration in the biopharma sector. With a strong focus on employee growth, we provide ample opportunities for professional development and career advancement, all while being part of a company that is making significant strides in rare disease treatments. Located in London, our team enjoys a vibrant city life, complemented by a supportive culture that values each individual's contributions and promotes a healthy work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Global Regulatory Affairs Manager – Biopharma in Watford
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with rare diseases. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in regulatory strategies.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for the EU, US, and ROW markets. Understanding the nuances of each region can set you apart from other candidates and demonstrate your commitment to the role.
✨Tip Number 3
Consider reaching out to current or former employees of the company to gain insights into their culture and expectations. This can help you tailor your approach during interviews and show that you are genuinely interested in the organisation.
✨Tip Number 4
Stay updated on recent developments in biopharma regulations, particularly those affecting rare diseases. Being knowledgeable about current events and changes in legislation will demonstrate your expertise and enthusiasm for the role.
We think you need these skills to ace Global Regulatory Affairs Manager – Biopharma in Watford
Some tips for your application 🫡
Understand the Role:Thoroughly read the job description for the Global Regulatory Affairs Manager position. Make sure you understand the responsibilities and requirements, especially regarding regulatory submissions and experience in EU/US/ROW markets.
Tailor Your CV:Customise your CV to highlight relevant experience in Regulatory Affairs, particularly your work with drug registration in various markets. Emphasise any specific achievements related to regulatory submissions or managing post-approval processes.
Craft a Compelling Cover Letter:Write a cover letter that connects your background to the role. Discuss your experience with regulatory strategies and how it aligns with the company's focus on rare diseases. Show enthusiasm for the opportunity to contribute to their expanding portfolio.
Proofread Your Application:Before submitting, carefully proofread your CV and cover letter for any errors or typos. A polished application reflects attention to detail, which is crucial in Regulatory Affairs.
How to prepare for a job interview at Apsida Life Science
✨Know Your Regulatory Landscape
Familiarise yourself with the latest EU and US regulatory guidelines, especially those related to rare diseases. Being able to discuss recent changes or trends in regulatory affairs will demonstrate your expertise and commitment to the field.
✨Highlight Relevant Experience
Prepare to discuss your previous roles in Regulatory Affairs, particularly any experience you have with post-approval submissions and marketing authorisation applications. Use specific examples to illustrate how your background aligns with the responsibilities of the Global Regulatory Affairs Manager position.
✨Showcase Your Strategic Thinking
Be ready to explain how you would approach the design and execution of regulatory strategies for new products. Discuss any past experiences where you successfully managed complex submissions, as this will highlight your ability to think strategically and manage multiple projects.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's expansion plans and their approach to regulatory challenges in rare diseases. This not only shows your interest in the role but also your understanding of the industry's complexities.
