Offer summary

Qualifications:

Bachelor's degree in a relevant field with 3+ years of experience, or an advanced degree with more experience for senior roles., Deep understanding of pharmaceutical development and manufacturing processes., Comprehensive knowledge of global CMC regulatory requirements and submission processes., Exceptional written and verbal communication skills. .

Key responsibilities:

Coordinate various global regulatory submissions including INDs, BLA/NDS/MAA, and Annual Reports.

Assist in the preparation and ensure compliance of regulatory submissions.

Manage submission timelines and collaborate with cross-functional teams for documentation.

Facilitate communication between teams and regulatory authorities, and maintain regulatory documentation.

Job description

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.

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