Senior / Regulatory Affairs Consultant (Small Molecules and Biologics)
Parexel International, Topeka, Kansas, United States, 66652
Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. In this role, you will help ensure our clients’ investigational, new, and marketed small‑molecule and biologic products are developed and maintained in full alignment with global regulatory requirements. Your primary geographic focus will include the United States, European Union, and Canada, with an emphasis on enabling timely approvals and supporting sustained market access.
You will contribute to both operational execution and strategic regulatory planning, working across a diverse portfolio of programs. The ideal candidate thrives in a collaborative environment and brings a balanced blend of hands‑on authoring expertise and forward‑looking regulatory insight.
Key Responsibilities Strategic CMC Leadership
Provide regulatory strategy input for small molecule and biologic products
Support regulatory leads in developing contingency plans for CMC‑related scenarios
Represent CMC Regulatory Affairs in cross‑functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Submission & Documentation Excellence
Prepare, coordinate, and review CMC and GMP‑related documents for regulatory submissions
Develop CMC strategies for products across all phases—from early development to marketing applications and post‑approval changes
Cross‑Functional Collaboration
Partner with manufacturing, quality, and external organizations to address CMC‑related issues
Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
Support planning and execution of Health Authority meetings, including mock sessions
Process Optimization & Innovation
Identify and implement process improvements to enhance regulatory efficiency and readiness
Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions
Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer
Regulatory Systems & Reporting
Experience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals is a plus
Ensure audit readiness and version control through meticulous documentation and system management
Qualifications Experience & Expertise
4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
In‑depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics. Previous experience with combination device products is a plus!
Skills & Attributes
Strategic and proactive mindset with strong operational execution
Excellent analytical, problem‑solving, and negotiation skills
Effective communicator with strong interpersonal, presentation, and leadership abilities
Ability to manage multiple projects independently in a matrixed, multicultural environment
Proficiency in Microsoft Office Suite and regulatory systems
Education
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field
Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred
RAC certification is a plus
Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based in other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.
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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You will contribute to both operational execution and strategic regulatory planning, working across a diverse portfolio of programs. The ideal candidate thrives in a collaborative environment and brings a balanced blend of hands‑on authoring expertise and forward‑looking regulatory insight.
Key Responsibilities Strategic CMC Leadership
Provide regulatory strategy input for small molecule and biologic products
Support regulatory leads in developing contingency plans for CMC‑related scenarios
Represent CMC Regulatory Affairs in cross‑functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Submission & Documentation Excellence
Prepare, coordinate, and review CMC and GMP‑related documents for regulatory submissions
Develop CMC strategies for products across all phases—from early development to marketing applications and post‑approval changes
Cross‑Functional Collaboration
Partner with manufacturing, quality, and external organizations to address CMC‑related issues
Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
Support planning and execution of Health Authority meetings, including mock sessions
Process Optimization & Innovation
Identify and implement process improvements to enhance regulatory efficiency and readiness
Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions
Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer
Regulatory Systems & Reporting
Experience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals is a plus
Ensure audit readiness and version control through meticulous documentation and system management
Qualifications Experience & Expertise
4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
In‑depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics. Previous experience with combination device products is a plus!
Skills & Attributes
Strategic and proactive mindset with strong operational execution
Excellent analytical, problem‑solving, and negotiation skills
Effective communicator with strong interpersonal, presentation, and leadership abilities
Ability to manage multiple projects independently in a matrixed, multicultural environment
Proficiency in Microsoft Office Suite and regulatory systems
Education
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field
Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred
RAC certification is a plus
Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based in other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.
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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