Freelance Regulatory Affairs Project Manager – Clinical Trial Applications

4 days ago

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ProPharma

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Pharmaceuticals • Biotechnology • Healthcare Insurance

ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.

5001 - 10000 employees

Founded 2001

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $8.6M Venture Round on 2020-10

📋 Description

• Provide guidance and support as a project leader on a cross functional basis within the Regulatory Affairs CTA group • Work effectively with various stakeholders to ensure each projects success • Lead the preparation, review and submit regulatory clinical trial applications within the EU • Ensure all submission activities meet key regulations within the region • Ensure compliance is achieved to the EU CTR regulations throughout each project • Implement and submit key documentation on to our clients systems • Provide key project leadership across a range of groups • Ensure all timelines and milestones are achieved throughout the project • Overall support our client with strategic and operational goals within the Regulatory Affairs CTA space

🎯 Requirements

• Must be educated within a life science discipline to at least a BSc or higher • Proven experience working within Regulatory Affairs linked to Clinical trial applications is a must • Can demonstrate key project management skills within a similar setting • Thorough experience working to all key regulations within the EU • Strategic and operational skills within the area are a must • Fluency in English is a must.

🏖️ Benefits

• 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.