CMC Regulatory Affairs - Biologics - Senior / Consultant, Regulatory Affairs - US or Canada (Talent Pool)

Join Our Growing Team of CMC Regulatory Professionals!

Due to our ongoing success, we expect to be growing our North American CMC Regulatory biologics team!

Join Our Growing Team of CMC Regulatory Professionals!

As we prepare for future growth, we are looking for skilled CMC regulatory experts to become part of a large, dedicated client FSP program. We’re seeking seasoned Regulatory CMC experts with extensive experience in developing and implementing CMC strategies, managing complex regulatory submissions, and leading interactions with health authorities.

As a CMC Regulatory Affairs Consultant / Senior Consultant, you will provide high-level strategic direction for late-stage and marketed products, as well as critical cross-project initiatives. You’ll have a proven track record of developing and implementing CMC strategies, managing complex regulatory submissions, and leading interactions with health authorities.

You will:

• Provide strategic direction and oversight for Global CMC aspects of late-stage and marketed products

• Deliver strategic input on critical cross-project topics, ensuring alignment with overall business objectives

• Develop comprehensive Global CMC strategies to support product development, registration, and lifecycle management

• Develop and oversee CMC strategies for complex regulatory submissions ie. INDs, IMPDs, BLAs, MAAs, post-approval variations/supplements, and responses to health authority questions

• Author and review high-level regulatory submissions ensuring submissions conform to relevant health authority guidelines and regulations

• Lead submission preparation meetings and coordinate cross-functional input

• Lead regulatory CMC discussions and interactions with Health Authorities

• Represent the company in high-level meetings with regulatory agencies

• Oversee regulatory assessments of manufacturing changes and provide expert guidance on CMC-related regulatory implications of proposed changes

• Lead critical submission preparation meetings and regulatory strategy discussions

• Address complex reviewer comments and manage sensitive regulatory correspondence

• Provide regular updates to senior management on project status, risks, and key milestones

• Work closely with senior leaders across various departments, including R&D, Manufacturing, Quality Assurance, and Clinical Development

• Facilitate effective communication between internal teams, external partners, and regulatory authorities

• Provide expert CMC regulatory guidance to support critical business decisions and product lifecycle management

• Stay at the forefront of evolving CMC regulations, guidelines, and industry best practices

• Drive the development and implementation of innovative CMC regulatory strategies

In addition to the duties above, as a CMC Regulatory Affairs Senior Consultant, you will:

• Influence and lead at senior levels within an organization

• Be a visionary leader with the ability to anticipate and navigate complex regulatory challenges

• Be a strategic thinker with a talent for innovative problem-solving and risk management

• Demonstrate strong leadership skills with the ability to influence cross-functional teams and senior management

Educational and Experience Requirements:

The CMC Regulatory Affairs career path offers opportunities for professionals with varying levels of education and experience:

• Consultant: Bachelor’s degree with an advanced degree preferred with 10+ years of experience

• Senior Consultant: Bachelor’s degree with an advanced degree Ph.D. preferred with 15+ years of experience

Ideal Candidate Profile:

We seek individuals who embody a unique blend of qualities essential for success in the dynamic field of CMC Regulatory Affairs:

• Previous CMC biologics experience is required

• 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.

These roles 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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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.