CMC Regulatory Affairs Profesionals

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.