Our client is excited by the possibilities and opportunities that their work offers in having an impact on the lives of patients. When they deliver a life-changing medicine, that success comes from the combined efforts of all of their people.
The position with be on our clients site in Abingdon, Cambridge on a busy and innovative science park - Granta Park.
The Regulatory Affairs Director, Emerging Markets (RAD) is accountable for the development and implementation of the International regulatory strategy 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, markets and patients.
Your main duties will be to:
· Lead development, communication and updates of the International section of the Regulatory Strategy Document (RSD) for assigned products/projects.
· Be accountable for the delivery of regulatory milestones.
· Be part of the objective assessment of emerging data against aspirations and update senior management in GRAPSQA and International Commercial on project risks/mitigation activities.
· Serve as the single point of contact and Global Regulatory Affairs (GRA) representative on Regional Product Teams.
· Lead the planning and construction of the International dossier.
· Lead 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.
· Regional 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.
· Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
The 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 delivery in the role.
Key requirements include:
· 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.
· Proven leadership and program management experience.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45321 in all correspondence.
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