- Lead the regulatory CTA submission process from start to finish for multiple clients and projects
- Coordinate and manage multiple projects simultaneously while ensuring deadlines are met
- Manage a team of regulatory professionals and provide guidance to ensure successful project completion
- Act as a client liaison and represent ProPharma Group in a professional and effective manner
- Collaborate with cross-functional teams and stakeholders to ensure project success
- Ensure all regulatory documents are accurate and comply with relevant regulations
- 5 to 10 years of experience working in the clinical trial/regulatory space
- Demonstrable experience leading complex projects
- Experience working across different projects concurrently
- Proven line management experience
- Experience with both CTD and CTR submissions
- IVD knowledge would be a bonus but not a necessity
- Experience working in Veeva Vault
- Organised, proactive and self-motivated individual with a keen eye for detail, ability to prioritise tasks effectively and ability to delegate to team members
- Must have experience working in a client-facing role and be able to represent ProPharma Group at its best
- ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.
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Senior Manager/Associate Director - Stockholm, United States - ProPharma Group
Description
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.
Associate Director / Senior Regulatory CTA Project Manager - ProPharma GroupResponsibilities:
Requirements:
If you are an experienced regulatory professional who is passionate about delivering exceptional service to clients and enjoys working in a fast-paced, dynamic environment, we want to hear from you.
ProPharma Group offers a competitive salary, excellent benefits package, and opportunities for professional development and advancement. Apply today to join our teamWe 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.
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