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For Companies At a Glance
- Tasks: Develop international regulatory strategies and manage multiple submissions in a fast-paced environment.
- Company: Join Parexel, a leading name in pharmaceutical and biotech consulting.
- Benefits: Flexible work options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in global health by guiding innovative products to market.
- Qualifications: 10+ years in regulatory affairs with a relevant scientific degree.
- Other info: Dynamic team culture with leadership opportunities and career advancement.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Parexel is seeking an experienced Regulatory Affairs Professional to join our dynamic team as a Senior Regulatory Affairs Consultant. This strategic position requires a proactive and agile regulatory professional able to build strategy, drive execution, and address challenges involved in gaining market approvals across international regions. You will provide expert guidance to our clients and delivery teams while managing multiple projects in a fast‑paced, results‑oriented environment. The role can be home or office based in various European locations.
Key Responsibilities
- Develop comprehensive international regulatory submission strategies for a wide variety of products and projects including CTAs, MAAs and lifecycle management.
- Provide strategic guidance to clients and delivery teams on requirements and submissions across international regions.
- Support or act as Project Lead, working with local market Regulatory Affairs experts to optimize strategies for specific submissions.
- Guide delivery teams in the creation and maintenance of international dossiers.
- Drive and manage multiple regulatory submissions simultaneously.
- Ensure effective regulatory representation in partnership with appropriate technical experts at health authority meetings.
- Document discussions and agreements with regulatory authorities clearly and comprehensively.
- Monitor and stay abreast of key changes in the regulatory environment of international markets.
- Create and perform regulatory intelligence surveys.
- Provide objective assessment of intelligence data.
- Communicate regulatory requirements and propose submission strategies to clients.
- Coach, mentor and lead regulatory teams to ensure objectives are successfully delivered on time and with quality.
- Identify and mitigate risks with respect to international submissions.
- Guide cross‑functional team discussions and drive regulatory solutions.
Skills and Experience Required
- University degree in a relevant scientific discipline (e.g., Biomedical Sciences, Chemistry, Pharmaceutical Sciences).
- 10+ years of experience in the pharmaceutical/biotech industry, with substantial experience in Regulatory Affairs.
- Broad background in pharmaceutical business and experience in several areas within regulatory affairs (e.g., Global, European, International, Marketing Company or health authority experience).
- Experience with biologics/vaccines/infectious diseases/oncology and rare diseases strongly preferred.
- Leadership in managing regulatory agency negotiations and organizing Scientific Advice Meetings with health authorities.
- Strong knowledge of CTD format and eCTD submission builds, including preparation of Modules 1‑5 documents.
- Experience with Clinical Trial Applications and regulations relating to clinical trials.
- Strong influencing, negotiation, and relationship management skills.
- Advanced problem‑solving skills and drive to generate compliant regulatory solutions.
- Fluent English, written and spoken.
Senior Level Mid‑Senior level Employment type Full‑time Job function Business Development and Consulting Industries Pharmaceutical Manufacturing, Biotechnology Research, Hospitals and Health Care.
Senior Regulatory Affairs Strategist (home or office based) in Uxbridge employer: Parexel
Contact Detail:
Parexel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Strategist (home or office based) in Uxbridge
✨Network Like a Pro
Get out there and connect with folks in the industry! Attend conferences, webinars, or local meetups. The more people you know, the better your chances of landing that Senior Regulatory Affairs Strategist role.
✨Show Off Your Expertise
When you get the chance to chat with potential employers, don’t hold back! Share your insights on regulatory strategies and recent changes in the market. We want to see your passion and knowledge shine through!
✨Tailor Your Approach
Every company is different, so make sure you tailor your discussions to what they need. Research Parexel’s projects and challenges, and come prepared with ideas on how you can help them succeed in their regulatory submissions.
✨Apply Through Our Website
Don’t forget to apply directly through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step to engage with us directly.
We think you need these skills to ace Senior Regulatory Affairs Strategist (home or office based) in Uxbridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Strategist role. Highlight your relevant experience in regulatory affairs, especially in international submissions and project management. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills can help us at Parexel. Be specific about your achievements and how they relate to the responsibilities of the role.
Showcase Your Leadership Skills: Since this role involves coaching and mentoring, make sure to highlight any leadership experiences you've had. We love to see examples of how you've guided teams or managed projects successfully in the past.
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 gives you a chance to explore more about our company culture and values.
How to prepare for a job interview at Parexel
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to the pharmaceutical and biotech industries. Be prepared to discuss your experience with CTAs, MAAs, and eCTD submissions in detail. This shows you're not just familiar with the basics but are also up-to-date with current practices.
✨Showcase Your Strategic Thinking
During the interview, highlight specific examples where you've developed comprehensive regulatory submission strategies. Discuss how you’ve navigated challenges in gaining market approvals and what strategies you employed to overcome them. This will demonstrate your proactive approach and ability to think critically.
✨Demonstrate Leadership Skills
Since this role involves coaching and mentoring teams, be ready to share instances where you've led projects or guided cross-functional teams. Talk about how you managed negotiations with regulatory agencies and any successful outcomes that resulted from your leadership.
✨Stay Current with Industry Trends
Keep an eye on recent changes in the regulatory environment and be prepared to discuss how these might impact the industry. Showing that you actively monitor regulatory intelligence surveys and can provide objective assessments will set you apart as a knowledgeable candidate.
