Manager/Associate Director - Regulatory Affairs, CMC

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Manager/Associate Director - Regulatory Affairs, CMC

View more categories View less categories Sector Legal Role Manager Contract Type Permanent Hours Full Time

Site Name: UK - London - New Oxford Street, Switzerland - Zug, UK - Hertfordshire - Stevenage
Posted Date: Jan

Are you interested in a highly visible regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs CMC role could be an ideal opportunity to explore.

As a Regulatory Affairs Manager/Associate Director, you will be responsible for regulatory submissions, interactions, and strategy related to products within the UK.

Depending on candidate's experience we will offer Manager or Associate Director level role.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

In this role you will

• Drive the CMC strategy, coordinate the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, ensuring compliance with evolving regulatory requirements. Identify risks to the business associated with submission data and information packages and provide and communicate well defined risk mitigation strategies.
• Mentor or train staff, manage project activities for multiple complex projects and teams simultaneously, and provide strategic direction, data assessment and conclusions within and across departments.
• Engage CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment).
• Deliver CMC regulatory strategy to support major inspections and quality incidents.
• Ensure submission content complies with regulations, expediting review and approval of global CMC applications. Identify risks to the business associated with submission data and information packages and provide and communicate well defined risk mitigation