Regulatory Affairs Director - Emerging Markets
My client is a top 10 pharmaceutical organisation with a broad therapy focus and an envious pipeline within Oncology, CVS and Respiratory to name a few of their therapy areas. Due to expansion they are looking to hire a number of Regulatory Directors within their emerging markets function. This would be focused on specific early stage therapy areas and late stage individual products. Geographic spread would be across Latam, MEWA, CIS/Russia and Asia Pacific.
This would sit within a team of five and have full strategic responsibility for first registrations in new markets for innovative products and liaison with local affiliates to maintain the existing licences and provide strategic support for product changes.
- Accountable for the development and implementation of the international (emerging markets) regional regulatory strategy for a product/ group of products
- Emerging Market regulatory needs into the Global Regulatory Strategy Team and for ensuring that the strategy is designed to drive optimal market access including delivery of a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, and patients.
- Accountable for interacting with International/Area commercial and cross-functional teams to ensure business needs are understood and to ensure regional commercial engagement with the proposed regulatory strategies/risks/mitigation plans
- Accountable for the delivery of key regional regulatory milestones including assessment of the approvability of the program together with appropriate risk mitigation measures
- To define innovative strategies to partner and interact with key regulatory authorities in the region to optimize the predictability of the regulatory outcome for the specific project(s) and to provide the regulatory platform for optimal market access
- Partner with key influencers/shapers of policy and therapeutic guidelines in the region including Health Authorities - payers and key opinion leaders
- For international/emerging markets, define and ensure preparation of the regional regulatory component of the product's development plan, regulatory strategy document, Core Datasheet, target product profile, submissions to health authorities, and labelling
- Participate in and contribute to the Value Team activities for the project/s as appropriate
- Lead the International Regulatory team and participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
- Act as Regulatory Intelligence lead for key strategic markets
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In case you have difficulty in applying or if you have any questions, please call David Nixon on 0203 0789 544 or upload your CV on our website www.proclinical.com. A full job description is available on request.
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