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New · posted Oct 29

Parexel · Biotechnology

Regulatory Affairs Consultant, CMC – Biologics

  • Remote, US
  • Remote
  • Full-time
  • Senior & Principal
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PayNot published
EmploymentFull-time
LocationRemote, US
LevelSenior & Principal
FunctionRegulatory CMC
DeadlineOpen until filled

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.

What you need

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

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

Preferred Qualificationsnice to have

  • 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

Skills named in this posting

What you'll do

  • 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.

Pay and benefits

Parexel didn't publish pay for this role

See what similar roles pay on Regulatory Jobs, or try the salary calculator.

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!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

Two Parexel colleagues talking and smiling as they walk past the colorful With Heart wall in the office

From the posting

About Parexel

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.

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®.

Parexel company page · 47 open roles
Equal opportunity, accessibility and legal noticesParexel's statements, word for word

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.

Job intelligence

The context around this role

Live data · November 3, 2026

Salary intelligence

How the pay compares

Senior & Principal roles in the US6 roles publishing pay

Middle half $138,375 to $196,625, median $175,000
Annual base pay
Annual base payLowMedianHigh
All US$138,375$175,000$196,625

Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory CMC

The general path across 92 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Parexel's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Associate CMC Regulatory Sciences Data Analyst · Assoc CMC Product Quality Compliance Specialist

    $77K median7 open

  2. This role

    Senior & Principal

    Often: Advisor/Sr. Advisor · Global Regulatory CMC Lead

    $175K median10 open

  3. Next step

    Manager

    Often: Manager, CMC Regulatory Affairs · Manager, Regulatory Affairs CMC

    $153K median22 open

  4. Later

    Director

    Often: Director, Global Regulatory Affairs · Director, Regulatory CMC

    $209K median49 open

  5. Later

    VP & Executive

    Often: Global Head of Technical Regulatory & Quality · Head of Regulatory CMC

    4 open

Career resources on Regulatory CMC

Skills DNA

What this role leans on

How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 5 linesLab testing and methods: 3 linesDocumentation and SOPs: 6 linesInvestigations and CAPA: 2 linesRegulatory submissions: 8 linesQuality systems and risk: 2 linesData and digital systems: 2 linesClinical trial conduct: 1 lineCollaboration and leadership: 10 linesGMPLab testingDocumentationInvestigationsSubmissionsQuality systemsData systemsClinical trialsTeamwork
  • Collaboration and leadership10
  • Regulatory submissions8
  • Documentation and SOPs6
  • GMP and compliance5
  • Lab testing and methods3
  • Investigations and CAPA2
  • Quality systems and risk2
  • Data and digital systems2
  • Clinical trial conduct1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

Parexel on Regulatory Jobs

47
Open roles
46
Distinct roles
6
Locations

By discipline

  • Clinical28 60%
  • Regulatory18 38%
  • Quality1 2%

By level

  • Senior & Principal31 66%
  • Manager10 21%
  • Associate & Specialist5 11%
See all 47 Parexel roles

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Regulatory Affairs Consultant, CMC – Biologics at Parexel

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