BeOne Medicines, formerly known as BeiGene, is a global next-generation oncology company founded in 2010 with the vision of expanding access to high-quality can
Associate Director, Regulatory Affairs
Location
United Kingdom
Posted
4 days ago
Salary
£80.7K - £100.9K / year
Seniority
Senior
Job Description
Associate Director, Regulatory Affairs
BeOne Medicines
• 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.
Job 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
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