Senior Regulatory Affairs Consultant – CMC Biologics

Parexel; United States; Remote; USD 130.000 - 170.000; Vollzeit

Benefits dieser Stelle

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company Match

Pet Insurance

Zusammenfassung

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics to join our team in a remote capacity. You will lead regulatory strategy and submissions for both biologics and small molecules, collaborating with manufacturing, quality, and project teams to ensure GMP-compliant development across FDA, EMA, and Health Canada.

Ideal candidates bring 7+ years of CMC experience, strong analytical and communication skills, and the ability to manage multiple projects in a matrixed

Qualifikationen

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD).
• 7+ years of CMC experience with regulatory filing documentation.
• Knowledge of drug development processes, GMP requirements, and global regulations.
• Experience preparing CMC sections for IND/NDA/DMF submissions for FDA/EMA/Canada.
• Strong understanding of the global regulatory environment.
• Analytical, negotiation, and communication skills; able to work in a matrix environment.
• Proficiency with Microsoft Office applications.

Aufgaben

• Develop CMC regulatory strategies for biologic and small molecule products.
• Prepare, coordinate, and review CMC and GMP documents for regulatory submissions.
• Represent CMC regulatory affairs in project meetings and provide guidance to cross-functional teams.
• Collaborate with manufacturing, quality, and partner organizations to address CMC issues.
• Support health authority CMC meetings and post-approval changes.
• Utilize tools such as CREDO, ORIOM, Trackwise Digital, TRS Viewer.

Kenntnisse

Analytical thinking

Regulatory affairs

Problem solving

Communication skills

Project management

Ausbildung

Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy

Master's or PhD in related field (preferred)

Tools

CREDO

ORIOM

Trackwise Digital

TRS Viewer

Microsoft Office

Jobbeschreibung

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.

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 a Senior Regulatory Affairs Consultant – CMC Biologics to join our team in a remote capacity. As a Senior Regulatory Affairs Consultant – CMC Biologics, you will support regulatory strategy and compliance for drug development across investigational, new, and marketed products for large-dedicated biopharmaceutical client partnership. This position plays a key role in ensuring products are developed and maintained in compliance with global regulatory requirements, supporting submissions to the FDA, EMA, and Health Canada. You'll collaborate with cross-functional teams including manufacturing, quality, and project management, follow industry-standard processes, and contribute to product development from early stages through post-approval. Responsibilities include developing CMC regulatory strategies, preparing regulatory submissions, and ensuring compliance with GMP and regulatory guidance, with opportunities to deepen your expertise in pharmaceutical development and influence regulatory outcomes.

You’ll join a fast-paced, growth-oriented environment focused on making a meaningful impact through advancing biopharmaceutical development, ensuring regulatory compliance, and supporting global market access. With diverse teams and continuous learning opportunities, the CMC Regulatory Affairs Specialist can explore career paths and expand skills across regulatory affairs, quality assurance, and pharmaceutical development.

Key Responsibilities

• Support regulatory leads in developing CMC regulatory strategies and contingency plans for biologic and small molecule drug substances, drug products, and drug-device combination products
• Determine regulatory and scientific/technical requirements for CMC and GMP-related submissions and regulatory inquiries
• Represent CMC regulatory affairs in project team meetings and provide regulatory guidance and perspective to cross-functional teams in conjunction with global regulatory leads
• Prepare, coordinate, and review all CMC and GMP-related documents for submission to regulatory authorities to ensure compliance with regulatory standards, company requirements, and scientific/technical specifications
• Develop CMC regulatory strategies for developmental phase products from early development through marketing applications, and support post-approval changes for marketed products
• Interact with manufacturing, quality, and partner organizations to address CMC-related issues and ensure alignment across functional areas
• Develop and maintain collaborative relationships with local and global functional units, manufacturing sites, contract manufacturers, and external partner companies
• Support regulatory leads in preparation for health authority CMC meetings and mock meetings
• Assess and develop innovative ideas to optimize CMC regulatory departmental processes and improve efficiencies
• Demonstrate proficiency with required tools and systems including CREDO, ORIOM, Trackwise Digital, and TRS Viewer

Candidate Profile

You’ll thrive in this role if you bring:

• Strengths in strategic thinking, regulatory analysis, and problem-solving
• Experience working in pharmaceutical development, regulatory affairs, or a highly regulated environment
• The ability to collaborate across teams and communicate clearly with manufacturing, quality, and regulatory stakeholders
• A quality-focused mindset and strong attention to detail in regulatory documentation
• Comfort working with regulatory information systems, document management platforms, and Microsoft Office applications

Required Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD)
• 7+ years of CMC experience in the pharmaceutical industry with a demonstrated history of successful regulatory filing documentation
• Comprehensive knowledge of drug development processes, pharmaceutical technology, drug manufacturing processes, and GMP requirements
• 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 experience preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canada
• Comprehensive understanding of the global regulatory environment
• Strong analytical, problem-solving, organizational, and negotiation skills
• Strong collaborative, interpersonal, communication, and presentation skills
• Demonstrated ability to work independently, manage multiple projects, and prioritize in a matrixed environment
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook)

Preferred Qualifications

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

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.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

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.