Regulatory Affairs Consultant, CMC – Biologics

Parexel; Denver (CO); A distancia; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

401(k) with Company match

Tuition Reimbursement

Vacation/Holiday/Sick Time

Descripción de la vacante

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to provide regulatory strategy for biologics and small molecules, focusing on US, EU, and Canada regulatory needs. This remote role collaborates with manufacturing, quality, and global teams to prepare GMP/CMC submissions and support health authority meetings.

You will contribute to early development through post-approval changes, ensuring compliant, timely approvals and continuous improvement of processes in a fast-paced,

Formación

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or Pharm.D.
• 4–6 years CMC experience with regulatory filing
• Knowledge of GMP, drug development, and global regulations
• CM C regulatory requirements for biologics and small molecules
• Experience preparing CMC (Quality) sections for IND/NDA/DMF (FDA and Europe/Canada)
• Global regulatory environment awareness
• Proficient with Microsoft Word, Excel, PowerPoint
• Strong analytical, problem-solving and negotiation skills

Responsabilidades

• Develop and implement CMC regulatory strategies for biologic and small molecule products.
• Coordinate CMC submissions for regulatory authorities.
• Prepare and review CMC and GMP documents for submissions.
• Represent CMC Regulatory Affairs in project teams.
• Support health authority meetings and CMC GRT meetings.
• Collaborate with manufacturing, quality, and cross-functional teams.
• Build relationships with internal and external stakeholders.

Conocimientos

Regulatory strategy

Analytical problem solving

Negotiation

Cross-functional collaboration

Regulatory submissions

Educación

Bachelor's degree in Pharmaceutical Sciences or Chemistry, or Pharm.D.

Master's or Ph.D. preferred

Herramientas

Trackwise Digital

TRS Viewer

Descripción del empleo

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. We move 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 a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity based. As a Regulatory Affairs Consultant, CMC- Biologics, you will provide CMC regulatory strategy input and expertise for investigational, new, and marketed biologic and small molecule drug products. Your work will help ensure these products are developed and maintained in compliance with global regulatory requirements and guidance, with primary responsibility for the US, EU, and Canada to support smooth, timely approvals and continued marketing.

This position plays a key role in regulatory compliance, the preparation of CMC and GMP documentation for health authority submissions, and support for health authority CMC meetings. You will collaborate with Regulatory Affairs leads and cross-functional partners across manufacturing, quality, Technical Operations, affiliates, and external partners, and contribute to regulatory strategy from early development through post-approval changes. Responsibilities include preparing and reviewing CMC and GMP-related submissions, representing CMC Regulatory Affairs in project team meetings, and supporting monthly global CMC GRT meetings, with opportunities to deepen your expertise and influence program outcomes.

You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic CMC regulatory input, high-quality submissions, and continuous improvement of departmental processes. Your work helps bring safe, high-quality medicines to patients, which is central to advancing clinical research. With diverse, global teams and continuous learning opportunities, you can explore career paths and expand skills across regulatory affairs and drug development.

Key Responsibilities

• Support Regulatory Affairs leads in developing CMC regulatory strategies and contingency plans for biologic and small molecule drug substances, drug products, and drug-device combination products.
• Support the development of CMC regulatory strategies for development-phase products, from early development through marketing applications, and for post-approval changes to marketed products.
• Determine regulatory and scientific and technical requirements for CMC and GMP-related submissions and inquiries.
• Prepare, coordinate, and review CMC and GMP-related documents for submission to regulatory authorities, ensuring compliance with regulatory requirements, company standards, and scientific and technical requirements.
• Support Regulatory Affairs leads in representing CMC Regulatory Affairs in project team meetings, providing regulatory guidance and perspective to cross-functional teams in conjunction with global regulatory leads.
• Support Regulatory Affairs leads in preparing for health authority CMC meetings, including mock meetings and meeting planning.
• Support monthly CMC GRT meetings with global cross-functional teams for assigned products.
• Interact with manufacturing and quality groups, partner organizations, and other stakeholders on CMC issues.
• Develop and maintain collaborative relationships with local and global functional units, including CMC Regulatory Affairs, manufacturing sites, Quality, Technical Operations, affiliates, external partner companies, contract manufacturers, packagers, and suppliers.
• Prepare departmental job procedures.
• Assess and develop innovative ideas to optimize local and global CMC Regulatory Affairs departmental processes, improving efficiencies and addressing current and future challenges.

Candidate Profile

You will thrive in this role if you bring:

• Strengths in proactive strategic thinking, analytical problem solving, and negotiation
• Experience working in the pharmaceutical industry within a regulated environment
• Strong collaborative, communication, and presentation skills, with the ability to lead meetings and work effectively in a matrixed environment and across cultural lines
• An operationally minded approach, with the ability to prepare high-quality technical documents and submissions using internal systems
• The ability to independently manage and prioritize a multi-project workload
• Proficiency with document management and regulatory information systems, Trackwise Digital, and TRS Viewer

Required Qualifications

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or a Pharm.D.
• 4-6 years of CMC experience in the pharmaceutical industry, with a history of successfully preparing regulatory filing documentation
• Comprehensive knowledge of the drug development process, pharmaceutical technology, drug manufacturing processes, GMP, and related issues
• Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug-device combination products
• Comprehensive knowledge and experience preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for the FDA and equivalent submissions for Europe and Canada
• Comprehensive understanding of the global regulatory environment
• Demonstrated experience with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Strong analytical, problem-solving, organizational, and negotiation skills

Preferred Qualifications

• Master's or Ph.D. degree, preferably in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology
• Regulatory Affairs Certification (RAC)
• Experience in CPP application filing through eCATS and 510(j)(3) reporting through nextGen portals

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.

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.

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