Director of Regulatory Affairs in Cambridge

Role - International Regulatory Affairs Director

Duration - 12 months

Inside IR35

Location - Central Cambridge, UK/ Remote

The International Regulatory Affairs Director Markets is accountable for the development and implementation of the International regulatory strategy for a group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.

The International Regulatory Affairs Director possesses strategic leadership skills, has an understanding of regional regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of the disease area is an important enabler to being able to influence cross-functional discussions with regional and/or Global Product Teams (GPT) and relevant stakeholders. Experience of regulatory systems across the International markets, and a thorough understanding of commercial factors is critical to success in the role.

Duties:

Project Regulatory Strategy

• Accountable for the development and implementation of innovative International regulatory strategies for a product/ group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business and patients. Strategy should reflect applicable international requirements.
• Leads the development, communication and updates of the International section of the Regulatory Strategy Document (RSD) for assigned products/projects. Ensure appropriate x-functional consultation, in particular with International Commercial, peer review and senior stakeholder endorsement from ILT and GPT.
• Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk and mitigation measures.
• Lead the objective assessment of emerging data against aspirations and update senior management in Regulatory and International Commercial on project risks/mitigation activities.

Leadership

• Serves as the single point of contact and Regional Regulatory Affairs representative on Regional Product Teams
• Leads the planning and construction of the International dossier
• Leads the development and implementation of an optimal regional (International) regulatory strategy for a product/group of products, ensuring International regulatory needs are incorporated into the development plan to ensure rapid market access with advantageous labelling. Through the GRST, ensures that regional regulatory needs are identified and incorporated into an optimum Global Regulatory Strategy that in turn contributes to the Global Product Development Plan.
• The International RAD is accountable for interacting with the regional commercial and cross-functional teams to ensure business needs are understood within the GRST and to ensure regional commercial engagement with the proposed regulatory strategies/risks/mitigation plans.
• Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.
• Lead the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
• Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
• Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
• Proactively contributes across RAD community and/or across Regulatory Excellence objectives and activities.

Regulatory Environment

• Partner with marketing company staff to monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise regional and/or Global Product Teams (GPT) or ILT accordingly.
• Partner with marketing company staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally.

Required Experience & Education

• Bachelor’s degree in a science related field and/or other appropriate knowledge/experience.
• Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions
• Extensive experience or equivalent of regulatory drug development including product approval/launch.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
• Proven leadership and program management experience.
• Ability to think strategically and critically evaluate risks to regulatory activities.
• Ability to work strategically within a complex, business critical and high profile development program.
• Successful leadership of a major regulatory approval in the International Region
• Strong cross-cultural awareness and ability to work independently with Commercial and Marketing Company colleagues from across the globe.
• Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
• Subject Matter Expert in International strategy and tactical delivery.

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