OneMain Financial Jobs

Responsibilities:

• Develop robust European regulatory plans, aligned with Corcepts global strategy, that lead to commercialization in new countries
• Provide regulatory guidance regarding European health authorities and interactions, including EMA
• Contribute and independently execute the filing plans for Europe in line with corporate, regional, and local business objectives
• Maintain awareness of new and developing legislation, regulatory policy, and technical guidance relating to small molecule therapies across oncology, neurology, endocrinology, and metabolic therapeutic areas, and communicate their implications cross-functionally
• Review and provide strategic input/advice on EU CTR submissions and/or queries
• Ensure high-quality regulatory submissions are made on time and achieve Corcepts goals
• Build out a team that oversees regulatory-related launch and post-marketing activities in the EU
• Work closely with the Quality Assurance department on relevant regulatory procedures applicable to the European region

Preferred Skills, Qualifications, and Technical Proficiencies:

• Bachelor of Science in a scientific discipline, Pharm D (/Pharmacist) or PhD preferred
• 12+ years of experience with leading EU and non-EU regulatory submissions and interactions with EMA and national agencies
• Regulatory-related product launch and post-marketing activities experience
• Experience with and knowledge of European regulatory regulations, directives, and guidelines
• Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills

Preferred Education and Experience:

• Deep knowledge of European regulatory regulations, directives, and guidelines
• Passionate about strong and to-the-point written work product
• Excellent planning, organization, time, and stakeholder management skills, including the ability to support and prioritize multiple projects
• Strong interpersonal capabilities and ability to build and maintain networks globally
• Possesses a sense of urgency; identifies challenges and problems and takes the initiative to identify solutions

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Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

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Corcept is an Equal Opportunity Employer

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