Global Regulatory Lead
A rapidly expanding pharmaceutical company is seeking to recruit a Global Regulatory Lead to their office in Cambridge. The organisation specialises in developing treatments for unmet medical needs. This position offers an exciting opportunity to bring expertise and skill to a highly prestigious organisation and bolster a career in the financial field.
- Responsible for assigned marketed products including global regulatory strategy and execution.
- Engage with stakeholders and partners across the business for provision of Regulatory Strategy advice and expertise for the assigned Marketed products.
- Responsible for ensuring quality delivery from vendors in line with agreed asset strategy.
- Provide regulatory expertise for the assigned marketed products.
- Act as Regulatory Lead and engage with the asset team and other stakeholders across the organisation to understand strategic and commercial goals for the assigned marketed products.
- Provide ownership and accountability for timely and effective regulatory strategy and execution for the assigned marketed products.
- Provide strategic direction and oversight of delivery output from outsourcing partners to ensure alignment with regulatory strategies, effective execution, and quality submissions.
- Responsible for regulatory representation in Alliance Management with Partner companies for their assigned marketed products, where applicable.
- Provide marketed product regulatory expertise into assigned Due Diligence for new assets.
Skills and Requirements:
- Extensive regulatory experience in registration and maintenance of products globally.
- Excellent knowledge and understanding of Emerging Markets regulatory requirements.
- Proven track-record of oversight and delivery of successful regulatory outcomes for marketed products across multiple regions.
- Leading agency negotiations and interactions for Established Brands where appropriate.
- Ability to work effectively within a flexible resourcing environment harnessing both internal and external (outsourcing) providers to deliver regulatory results.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.