CMC Regulatory Affairs - Biologics - - various levels - US or Canada (Talent Pool)

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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!

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

As we prepare for future growth, we are looking for skilled CMC regulatory experts to become part of 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 expert with extensive experience in developing and implementing CMC strategies, managing complex regulatory submissions, and leading interactions with health authorities, or somewhere in between, we invite you to apply for one of these exciting opportunities 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

As a CMC Regulatory Affairs Senior Associate, you will be responsible for developing global CMC strategies and managing regulatory submissions for both early-stage programs and marketed products. The ideal candidate will have extensive experience in authoring and reviewing regulatory submissions, performing regulatory assessments of manufacturing changes, and representing Regulatory CMC in cross-functional teams.

You will:

• Develop comprehensive Global CMC strategies for early-stage programs and marketed products

• Author and review regulatory submissions ie. INDs, IMPDs, post-approval commitments, Annual Reports, and Responses to regulatory authority questions ensuring submissions conform to relevant health authority guidelines and regulations

• Lead submission preparation meetings and coordinate cross-functional input

• Address reviewer comments and manage regulatory correspondence

• Address reviewer comments and manage regulatory correspondence

• Perform regulatory assessments of manufacturing changes

• Provide expert guidance on CMC-related regulatory implications of proposed changes

• Represent Regulatory CMC at project team meetings

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

• Provide CMC regulatory expertise to support business decisions and product development strategies

• Stay current with evolving CMC regulations, guidelines, and industry best practices

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:

• 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 the 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:

• 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.

Ideally candidates will be located in EST. Consideration, however, will be given to experienced Regulatory Professionals within the US or Canada in other regions who have the ability to work EST hours.

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 US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.