For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Essential Functions

• Develop and execute project work plans and lead complex sub-projects in the preparation of regulatory documentation, including reports, dossiers, applications, and responses to inquiries, under the guidance of senior team members.
• Lead the regulatory European CTA submission process from start to finish for multiple clients and small, discrete projects.
• Support more specialist clinical submission projects (IVD performance study applications, GMO applications etc).
• Conduct research and analysis of European regulatory requirements and guidelines relevant to assigned client projects.
• Manages complex tasks, expands upon data analysis, contributing to risk assessment, project planning and strategy.
• Oversee the maintenance of databases and records of regulatory information for assigned projects.
• Delegate work to junior colleagues and lead internal teams (scientific, clinical, etc.) to facilitate efficient project execution.
• Lead interactions with clients and regulatory agencies, under the supervision of senior team members.
• Build strong client relationships, manage client expectations and present in client meetings, where requested.
• Support development of client budgets.
• Stay informed of relevant regulatory developments in Europe and contribute to regulatory/industry workshops, trainings and calls for collaboration.
• Contribute to the ongoing improvement of internal regulatory processes and procedures.
• Other duties as assigned.

Necessary Skills And Abilities

• Experience leading small clinical trial application projects within Europe.
• Experience with both CTD and CTR submissions.
• Experience with clinical performance studies for devices highly desirable.
• Excellent research and analytical skills, with the ability to critically evaluate scientific and regulatory information.
• Strong attention to detail and a commitment to accuracy and quality.
• Proactive management of discreet projects, assuming responsibility for work assigned and delegated.
• Advanced project management knowledge with strategic focus
• Ability to effectively manage clients and manage project budgets
• Ability to work independently and as part of a team, fostering strong relationships with colleagues and mentoring junior colleagues.
• Strong negotiation, communication and interpersonal skills, including active listening.
• Eagerness to learn and adapt to new regulatory developments.
• Proficient in MS Office Suite and basic regulatory databases.

Educational Requirements

• Advanced degree (MSc/PhD) in a relevant field preferred.
• Bachelor’s degree in a life science field (e.g., biology, pharmacy, pharmacology, toxicology) or a related discipline necessary.

Experience Requirements

• 6-8+ years’ experience within regulatory sciences for development products preferred.
• Experience with European CTA submissions.
• Experience leading successful sub-projects and supporting client/stakeholder relationships.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***