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About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, _With Heart_ ®.

About the Role

We are seeking an experienced CMC regulatory professional to join our team as a Senior Regulatory Affairs Consultant, supporting post-approval vaccine products to join our team in remote capacity. As a Senior Regulatory Affairs Consultant, you will provide strategic leadership for the chemistry, manufacturing, and controls aspects of late-stage and marketed products. This position plays a key role in regulatory strategy, health authority engagement, submission quality, and manufacturing change management. You'll collaborate with senior leaders across R&D, Manufacturing, Quality Assurance, and Clinical Development, and shape CMC strategy from product development through registration and lifecycle management. Responsibilities include developing and overseeing CMC strategies for complex regulatory submissions and leading interactions with health authorities, with opportunities to deepen your expertise and influence program outcomes.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory CMC leadership, health authority engagement, and high-quality regulatory submissions. With diverse teams and continuous learning opportunities, you'll have the opportunity to explore career paths and expand skills across regulatory affairs and pharmaceutical development.

Key Responsibilities

+ Provide strategic direction and oversight for CMC aspects of late-stage and marketed products, and develop comprehensive CMC strategies to support product development, registration, and lifecycle management

+ Develop and oversee CMC strategies for complex regulatory submissions, including Investigational New Drug (IND) applications, Investigational Medicinal Product Dossiers (IMPDs), Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), post-approval variations and supplements, and responses to health authority questions

+ Author and review high-level regulatory submissions, ensure all submissions conform to relevant health authority guidelines and regulations, and lead submission preparation meetings with coordinated cross-functional input

+ Lead regulatory CMC discussions and interactions with Health Authorities, represent the company in high-level meetings with regulatory agencies, and build and maintain positive relationships with key regulatory stakeholders

+ Develop strategies for addressing complex regulatory questions and issues, and address complex reviewer comments and manage sensitive regulatory correspondence

+ Oversee regulatory assessments of manufacturing changes, establish data requirements and strategies for related regulatory submissions, and provide expert guidance on CMC-related regulatory implications of proposed changes

+ Represent Regulatory CMC at high-level project team meetings and governance committees, and lead critical submission preparation meetings and regulatory strategy discussions

+ Work closely with senior leaders across R&D, Manufacturing, Quality Assurance, and Clinical Development, and facilitate effective communication between internal teams, external partners, and regulatory authorities

+ Provide regular updates to senior management on project status, risks, and key milestones, and provide expert CMC regulatory guidance to support critical business decisions and product lifecycle management

+ Mentor and develop team members in Regulatory CMC practices and strategic thinking

+ Stay at the forefront of evolving CMC regulations, guidelines, and industry best practices, drive the development and implementation of innovative CMC regulatory strategies, and participate in or potentially lead relevant industry groups and regulatory authority initiatives

Candidate Profile

You'll thrive in this role if you bring:

+ Strengths in CMC regulatory strategy, complex regulatory submissions, and health authority interactions

+ Experience working in a regulated pharmaceutical environment, with a focus on CMC for late-stage and marketed products

+ The ability to collaborate across senior leadership teams, influence cross-functional stakeholders, and communicate clearly at every level

+ A patient-focused mindset, strong attention to detail, and a big-picture perspective

+ Comfort working with global regulatory submission processes, health authority expectations, and quality systems

Required Qualifications

+ Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field

+ Minimum of 10+ years of experience in Regulatory Affairs, with a strong focus on CMC for late-stage and marketed products

+ Extensive knowledge of global CMC regulatory requirements, submission processes, and health authority expectations, along with a deep understanding of pharmaceutical development, manufacturing processes, and quality systems

+ Proven track record of successful regulatory submissions and positive health authority interactions

+ Strong analytical, communication, organization, and problem-solving skills, with excellent project management and the ability to influence and lead at senior levels

Preferred Qualifications

+ Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field

+ Experience with both small molecules and biologics

+ Experience with a regulatory agency, such as the FDA or MHRA

Benefits and Compensation

+ Health, Vision & Dental Insurance

+ Tuition Reimbursement

+ Vacation/Holiday/Sick Time

+ Flexible Spending & Health Savings Accounts

+ Work/Life Balance

+ 401(k) with Company match

+ Pet Insurance

For a complete list of benefits, please visit www.parexel.com/us-benefits.

Parexel offers competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.

Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

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Senior Regulatory Affairs Consultant, CMC - Post-Approval Vaccines

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