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- Tasks: Lead regulatory projects for Middle East Africa, Turkey, CIS & Russia, ensuring timely NDA submissions.
- Company: Join a dynamic team focused on international growth in the pharmaceutical sector.
- Benefits: Enjoy flexible working options and a collaborative environment with diverse teams.
- Why this job: Make a real impact in global markets while advancing your career in regulatory affairs.
- Qualifications: 5+ years in Regulatory Affairs with a degree in Life/Health Sciences preferred.
- Other info: Contract position for 6 months, with potential for extension; hybrid work model.
The predicted salary is between 48000 - 72000 £ per year.
Are you an experienced Senior Regulatory Affairs Manager? Do you have experience in the International Growth Markets? If so, we would love to hear from you!
The successful candidate will become a member of our clients regulatory project team representing Middle East Africa, Turkey, CIS & Russia and Central Eastern European Markets in the International Growth Markets team with accountability for 1-3 products progressing through NDA planning, filing and approval.
This is a contract position, offered initially for 6 months, working 37.5 hours per week. (Preferably 2 days a week in the office / Inside IR35).
Responsibilities:- Provides regulatory support to IGM Cluster Head for new regulatory filings with specific individual accountability for development of NDA submission and major line extension including labelling strategies and execution.
- Manages the communication, development and implementation of NDA and major line extension strategy assigned product(s) in Middle East Africa, Turkey, CIS & Russia and Central Eastern European Markets.
- Working closely with global, regional and in-country regulatory teams.
- Responsible for development and delivery of regulatory strategy for assigned products.
- Working closely with partner and affiliate counterparts, supply chain, PV, commercial and medical colleagues where required to determine optimal NDA filing and launch strategy.
- Ensuring delivery of strategy to the timelines agreed working in partnership with CRO Regional Strategy lead for assigned products providing regional insights.
- Attend and contribute to other various cross-functional forums, including launch meetings.
- Taking time to review root cause and proposing/looking for improvements to our current systems and process, to improve our performance and consolidate IGM within the global organisation.
- BA/BS/University degree required - Life/Health Sciences preferred.
- Minimum 5+ years pharmaceutical/biotechnology industry experience in Regulatory Affairs, ideally in International/Emerging Markets.
- Skills and experience to represent the Region and IGM group on project teams.
- Experience and knowledge in the preparation of NDA submissions in the IGM region.
- Good knowledge and understanding of international regulatory affairs.
Candidates must be eligible to live and work in the UK.
Senior Regulatory Affairs Manager employer: Randstad Technologies Recruitment
Contact Detail:
Randstad Technologies Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Manager
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in International Growth Markets. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for the Middle East Africa, Turkey, CIS & Russia, and Central Eastern European Markets. This knowledge will help you demonstrate your expertise during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences with NDA submissions and how you've successfully navigated challenges in regulatory affairs. Be ready to provide examples that highlight your problem-solving skills.
✨Tip Number 4
Showcase your ability to work collaboratively with cross-functional teams. Highlight any past experiences where you effectively communicated and coordinated with various departments to achieve regulatory goals.
We think you need these skills to ace Senior Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Regulatory Affairs, particularly in International Growth Markets. Emphasise any relevant projects you've worked on, especially those involving NDA submissions and regulatory strategy.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the responsibilities mentioned in the job description. Discuss your experience with NDA planning and filing, and how you can contribute to the team representing the Middle East Africa, Turkey, CIS & Russia, and Central Eastern European Markets.
Highlight Relevant Skills: In your application, make sure to showcase your knowledge of international regulatory affairs and your ability to work with cross-functional teams. Mention any specific skills that align with the requirements, such as communication and strategic planning.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or typos. A polished application reflects your attention to detail, which is crucial in Regulatory Affairs.
How to prepare for a job interview at Randstad Technologies Recruitment
✨Showcase Your Regulatory Expertise
Make sure to highlight your experience in regulatory affairs, especially within the International Growth Markets. Be prepared to discuss specific examples of NDA submissions you've worked on and how you navigated the complexities of different regional regulations.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working closely with various teams, be ready to share instances where you've successfully collaborated with global, regional, or in-country regulatory teams. Emphasise your ability to communicate effectively across departments.
✨Understand the Market Landscape
Familiarise yourself with the specific challenges and opportunities in the Middle East Africa, Turkey, CIS & Russia, and Central Eastern European Markets. Showing that you have insights into these regions will demonstrate your preparedness for the role.
✨Prepare for Strategic Discussions
The interview may involve discussions about regulatory strategy and timelines. Be ready to articulate your approach to developing and delivering regulatory strategies, including how you would handle potential roadblocks in the NDA filing process.
