Associate Director, Regulatory Affairs

🕒 June 16

🇬🇧 United Kingdom – Remote

💵 £80.7k - £100.9k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 37%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Develop and implement UK regulatory strategies for development programs to secure and maintain marketing authorization in line with business objectives • Coordinate regulatory strategy with key internal stakeholders • Oversee and manage commercial products for the UK and Ireland • Lead the UK Regulatory Affairs team across development, registration, post-approval, and product lifecycle phases • Define UK MAA strategy and ensure incorporation into product development objectives • Prepare and manage UK MAA regulatory dossiers • Support labeling updates and management in Ireland using knowledge of EU MAA dossiers • Oversee regulatory agency communications, submissions, and approvals • Review and provide input into promotional materials for the UK and Ireland • Act as Regulatory Affairs liaison within the UK Leadership team and contribute to UK business strategy • Prepare for, moderate, and lead Health Authority interactions • Serve as the main MHRA contact for strategic, non-study-specific topics • Support the EU Regulatory Affairs team on clinical Health Authority matters • Anticipate and mitigate regulatory risks while monitoring regulatory intelligence, procedures, changes, and trends • Provide submission gap analyses and propose risk mitigation plans • Ensure compliance with EU and UK global regulatory requirements • Lead and mentor junior Regulatory Affairs professionals • Represent BeOne at UK industrial association meetings and congresses

🎯 Requirements

• Bachelor’s degree required; advanced degree preferred • Minimum of 8 years’ experience in the biotechnical or pharmaceutical industry • Minimum of 8 years’ experience in a Regulatory capacity with a broad background • Experience working with MHRA regulatory procedures is mandatory • Sound understanding of the drug development process, the pharmaceutical industry, and healthcare environment, including UK regulatory requirements and policy trends • Recent experience with oncology products and MAAs, ODD, and PIP preferred • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism • Extensive experience with Microsoft Office suite • Experience with Veeva regulatory publishing • Expertise with PowerPoint presentation authoring and presentation • Ability to lead and mentor junior team members

🏖️ Benefits

• Fully remote work in the UK • Travel to internal meetings in the UK monthly or bimonthly • Additional travel to EU locations occasionally

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