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- Tasks: Lead regulatory strategies and manage submissions for international market approvals.
- Company: Join Parexel, a dynamic leader in the pharmaceutical and biotech industry.
- 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: Collaborative environment with a focus on mentorship and career development.
The predicted salary is between 60000 - 84000 £ per year.
When our values align, there's no limit to what we can achieve. 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:
- Strategic Leadership
- 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 for the role:
- 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 Regulatory Affairs Strategist (home or office based) in London 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 London
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who work at Parexel or similar companies. A friendly chat can open doors and give you insider info on job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of international regulatory submission strategies. Be ready to discuss how you've tackled challenges in past roles, as this will show you're the proactive strategist we need.
✨Tip Number 3
Don’t just apply; engage! When you submit your application through our website, follow up with a personalised message expressing your enthusiasm for the role. It shows initiative and helps you stand out from the crowd.
✨Tip Number 4
Stay updated on regulatory changes in the industry. Being knowledgeable about current trends and challenges will not only help you in interviews but also position you as a valuable asset to any team.
We think you need these skills to ace Senior Regulatory Affairs Strategist (home or office based) in London
Some tips for your application 🫡
Show Your Strategic Side: When writing your application, make sure to highlight your experience in developing regulatory strategies. We want to see how you've tackled challenges and driven execution in previous roles, especially in fast-paced environments.
Tailor Your Experience: Don’t just send a generic CV! We love it when applicants tailor their experience to match the job description. Focus on your relevant skills in regulatory affairs, especially with CTAs, MAAs, and lifecycle management.
Be Clear and Concise: In your written application, clarity is key. We appreciate well-structured documents that get straight to the point. Make sure to document your achievements and responsibilities clearly, so we can easily see your impact.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Parexel
✨Know Your Regulatory Stuff
Make sure you brush up on the latest trends and changes in the regulatory landscape, especially in the areas of biologics, vaccines, and oncology. Being able to discuss recent developments will show that you're proactive and knowledgeable, which is key for a Senior Regulatory Affairs Strategist.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams or projects in the past. Highlight your experience in coaching and mentoring others, as well as any specific instances where you’ve navigated complex regulatory negotiations. This will demonstrate your ability to lead and inspire others in a fast-paced environment.
✨Master the Art of Communication
Since this role involves guiding clients and delivery teams, practice articulating complex regulatory concepts in a clear and concise manner. Be ready to explain how you would communicate regulatory requirements and submission strategies effectively to various stakeholders.
✨Be Ready for Scenario Questions
Expect to face scenario-based questions that assess your problem-solving skills and ability to manage multiple submissions simultaneously. Think about past challenges you've faced and how you overcame them, as this will help you demonstrate your strategic thinking and execution capabilities.
