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- Tasks: Lead regulatory strategies for a new biopharma product across global markets.
- Company: Join a well-established global pharmaceutical company expanding its rare disease portfolio.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Be part of a mission-driven team making a real impact in the biopharma industry.
- Qualifications: Requires a life science degree and 5 years of regulatory affairs experience.
- Other info: Contact Ethan Cortese at Apsida Life Science for more details.
The predicted salary is between 43200 - 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.
Global Regulatory Affairs Manager – Biopharma employer: MindMatch
Contact Detail:
MindMatch Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Regulatory Affairs Manager – Biopharma
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with biopharma and rare diseases. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for the EU, US, and ROW markets. Understanding the nuances of these regions will give you an edge during interviews and demonstrate your commitment to the role.
✨Tip Number 3
Prepare to discuss your previous experiences in managing regulatory submissions, particularly any successes you've had with variations, renewals, or clinical trial applications. Be ready to provide examples that showcase your expertise.
✨Tip Number 4
Research the company’s current portfolio and recent developments in their rare disease products. Showing that you are informed about their work will help you stand out as a candidate who is genuinely interested in contributing to their success.
We think you need these skills to ace Global Regulatory Affairs Manager – Biopharma
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 territories. 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 application materials. Check for spelling and grammatical errors, and ensure that all information is clear and professional. A polished application reflects your attention to detail, which is crucial in Regulatory Affairs.
How to prepare for a job interview at MindMatch
✨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 submissions in ROW countries. Be specific about your contributions to regulatory strategies and how they led to successful product approvals.
✨Showcase Your Communication Skills
As a Global Regulatory Affairs Manager, you'll need to liaise with various stakeholders. Practice articulating complex regulatory concepts clearly and concisely, as this will be crucial during your interview.
✨Prepare Questions for the Interviewers
Think of insightful questions to ask about the company's regulatory strategies and their approach to rare diseases. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
