CMC Regulatory Affairs Associate
Argentina, Remote求人ID R0000033740 カテゴリー Regulatory / Consulting
About this Role
Join Our Growing Team of CMC Regulatory Professionals!
As we prepare for future growth, we are looking for Regulatory Affairs professionals with CMC experience to join a large, dedicated client FSP program.
Whether you’re a detail-oriented professional passionate about regulatory affairs and eager to contribute to successful document submissions, a seasoned Regulatory CMC professional with experience implementing CMC strategies for Biological and/or vaccines projects, we invite you to apply for this exciting opportunity on our team.
As a CMC Regulatory Affairs Associate, you will:
- Play a crucial part in coordinating various Global regulatory submissions ie. INDs, IMPDs, BLA/NDS/MAA post-approval commitments, Annual Reports, and Responses to regulatory authority questions.
- Assist in the preparation and coordination of global regulatory submissions, ensuring all submissions are complete, accurate, and compliant with regulatory requirements
- Manage submission timelines and coordinate with cross-functional teams to gather necessary documentation
- Support the team in conducting regulatory assessments of manufacturing changes, analyze the potential impact, and assist in preparing documentation to support manufacturing change assessments
- Facilitate effective communication between cross functional teams and regulatory authorities
- Participate and facilitate project team meetings to provide regulatory input and updates
- Maintain accurate and up-to-date regulatory documentation
Focus on global experience is extremely important.
Educational and Experience Requirements:
The CMC Regulatory Affairs career path offers opportunities for professionals with varying levels of education and experience:
- Associate: Bachelor's degree in a relevant field with 3+ years of experience
- Senior Associate: Advanced degree (Ph.D. preferred) with 7+ years of experience
- Consultant: Advanced degree (Ph.D. preferred) with 10+ years of experience
- Senior Consultant: Advanced degree (Ph.D. preferred) with 15+ years of experience
These requirements reflect an increasing complexity and responsibility of each role, from entry-level positions to senior leadership.
Ideal Candidate Profile:
We seek individuals who embody a unique blend of qualities essential for success in the dynamic field of CMC Regulatory Affairs:
- Technical Proficiency: Deep understanding of pharmaceutical development, manufacturing processes, and quality systems.
- Regulatory Expertise: Comprehensive knowledge of global CMC regulatory requirements and submission processes.
- Strategic Thinking: Ability to develop and implement innovative regulatory strategies aligned with business objectives.
- Leadership: Proven track record of guiding cross-functional teams and influencing decision-making at various organizational levels.
- Communication: Exceptional written and verbal skills for effective interaction with internal teams, external partners, and regulatory authorities.
- Adaptability: Flexibility to navigate evolving regulatory landscapes and shifting priorities.
- Problem-Solving: Strong analytical skills and innovative approaches to addressing complex regulatory challenges.
- Project Management: Capability to manage multiple complex projects simultaneously while maintaining attention to detail.
- Industry Passion: Genuine enthusiasm for contributing to successful product development and regulatory submissions in the pharmaceutical sector.
This role offer exciting opportunities for growth and impact within a collaborative and forward-thinking team environment. Ideal candidates will be motivated by the chance to shape regulatory strategies, drive successful submissions, and ultimately contribute to bringing important medical advancements to patients worldwide.
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