Associate Director, European Regulatory Affairs
Vor 2 Tagen
On behalf of a biopharmaceutical company whose mission is to identify, develop and deliver life-changing therapies to people living with rare disease, I am currently looking for an Associate Director for the European Regulatory Affairs.
The company is growing and advancing a pipeline of potential first-in-class medicines targeting rare diseases with significant unmet needs and oftentimes no approved treatment options
The Associate Director, European Regulatory Affairs is responsible for providing technical regulatory leadership and in-depth expertise in establishing and executing regulatory strategies and leading interactions with internal stakeholders, partners and regulatory authorities to advance development of novel compounds in the orphan/rare disease space.
This position will be responsible for lifecycle management of assigned products.
**Tasks**:
As the principal regional liaison, provide regulatory strategic insight and procedural expertise in line with applicable regulatory guidelines.
Lead the development and implementation of regulatory strategies; manage regulatory activities and timelines for assigned projects and programs across product life cycles.
Develop and maintain regulatory and technical sections of pre-approval, MAA and post-approval submissions ensuring compliance with applicable requirements.
Oversee preparation, review and submission of high-quality clinical trial, pre/post authorization regulatory documents and responses to questions to regulatory agencies and ensure submissions are complete, properly formatted and comply with applicable regulatory requirements and timelines.
Lead interactions with regulatory authorities, including coordination through CRO for meetings and regulatory issues.
**Education/Experience Requirements**:
Bachelor's Degree/Science degree in a biological science is required. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.
At least 8 years regulatory affairs experience in the pharmaceutical or biotechnology industry or government health agency.
Demonstrated track record of successful approvals from a major regulatory agency is required. Prior regulatory agency liaison experience is essential.
Solid expertise and knowledge of the drug development process is required.
Extensive track record and experience in drafting and reviewing regulatory submissions (CTA, MAAs, Variations).
**Location**: Switzerland
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
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