Associate Director, Regulatory Affairs

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BeOne Medicines

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10,000+ employees

Founded 2010

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 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

• Responsible for developing and implementing UK regulatory strategies for product(s). • Lead the UK RA team to manage regulatory aspects of compounds. • Collaborate with key internal stakeholders on UK MAA strategy. • Manage the content and prepare regulatory (UK MAA) dossiers. • Oversee communications, submissions, and approvals from regulatory agencies. • Act as the RA liaison within the UK Leadership team and provide input into UK business strategy. • Anticipate and mitigate regulatory risks while maintaining knowledge of regulatory intelligence. • Mentoring junior team members and representing BeOne at UK industrial meetings.

🎯 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. • Experience working with MHRA regulatory procedures is mandatory. • Sound understanding of the drug development process and UK regulatory requirements. • Recent experience with oncology products and MAAs, ODD, PIP is preferred.

🏖️ Benefits

• Health insurance • Flexible work arrangements • Professional development opportunities