Associate Director Regulatory Research & Intelligence

JR United Kingdom; London; Remote; GBP 80,000 - 100,000; Full time

Job summary

Une entreprise leader dans la délivrance de thérapeutiques pour des maladies génétiques rares recherche un responsable en affaires réglementaires. Vous serez responsable de compiler et analyser des données et d'apporter des informations essentielles à la stratégie de développement des produits. Ce rôle exige une solide expérience au sein de l'industrie de la santé, avec une expertise particulière en matière de recherche et d'analyse.

Qualifications

• Master’s degree ou PhD en sciences de la vie requis.
• 8+ années d'expérience dans l'industrie de la santé, dont au moins 5 en affaires réglementaires.
• Compétences analytiques et recherche essentielles.

Responsibilities

• Soutenir les chercheurs réglementaires dans l'analyse des données pour les demandes de licenses.
• Contribuer à la stratégie de développement de produits réglementaires.
• Suivre les décisions de l'EMA et de la FDA.

Skills

Research and analytical skills

Attention to detail

Written communication

Verbal communication

Collaboration

Education

Master’s degree or PhD in life sciences

Tools

Regulatory research databases

Job description

Social network you want to login/join with:

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Client:

i-Pharm Consulting

Location:

london, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

5

Posted:

31.05.2025

Expiry Date:

15.07.2025

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Job Description:

Period - 12 Month Contract

Location - United Kingdom, London (Remote)

Inside IR35

The company is a leader in delivering therapeutics for serious and life-threatening rare genetic diseases. We focus on conditions that lack effective therapies and affect small patient populations, many of whom are children. Our aim is to improve outcomes for people with rare diseases by advancing therapeutics, care standards, and providing global support.

The Global Study Operations (GSO) function provides strategic direction on clinical studies, driving the delivery of high-quality data for asset registration and approval. This includes developing Clinical Development Plans, study planning, cross-functional leadership, trial expertise, and vendor oversight.

Responsibilities:

• Support senior Regulatory Researchers and senior Management by compiling and analyzing data and metrics for reports on regulatory pathways and development programs to support US and EU marketing license applications.
• Contribute to regulatory product development strategy by responding to information requests from product teams or senior management and providing an analysis of the regulatory environment.
• Identify the degree of clinical evidence supporting FDA and EMA marketing license applications across several therapeutic areas.
• Identify the issues raised during reviews and the approaches used to resolve the issues raised by health authorities.
• Perform searches across regulatory agency websites, reviews, and available databases to identify regulatory approval, labelling, and clinical trial design precedents.
• Keep management apprised of FDA and EMA decisions and proposals, regulatory developments, and new regulatory trends.
• Monitor and analyse emerging guidelines and trends that impact the industry and portfolio.
• Provide actionable communications to Regulatory Affairs and cross-functional teams on regulatory developments that could influence strategy, product portfolio, and business objectives.
• Generate regulatory research and intelligence newsletters and reports providing insights that inform decision-making.

Requirements:

• A Master’s degree or PhD in a life science is required.
• 8+ years of experience in the healthcare industry, including at least 5 years of experience in Regulatory Affairs is required.
• Substantial regulatory/clinical Phase I to Phase III development experience.
• Extensive research and analytical skills and attention to detail are essential to thoroughly research and document the details of development programs.
• Experience identifying trends in regulatory research information.
• Experience with regulatory research and intelligence databases (e.g., Cortellis).
• Strong written, verbal, and presentation communication skills, with the ability to research and present key messages to senior management.
• Strong collaborative skills with the ability to work closely with internal stakeholders.

If you are interested in finding out more about this role or others, please contact Sharleney Chandraratna at [emailprotected] or call: [phone]