Parexel
CMC Regulatory Affairs Senior/Consultant - Small Molecules
Parexel, Trenton, New Jersey, United States
CMC Regulatory Affairs Senior/Consultant - Small Molecules
Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client’s investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access.
Key Responsibilities Strategic CMC Leadership
Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug‑device combination products are a plus)
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
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. Previous experience with biologics or combination device products are 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
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Business Development and Consulting
Industries
Pharmaceutical Manufacturing and Biotechnology Research
Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.
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Key Responsibilities Strategic CMC Leadership
Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug‑device combination products are a plus)
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
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. Previous experience with biologics or combination device products are 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
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Business Development and Consulting
Industries
Pharmaceutical Manufacturing and Biotechnology Research
Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.
#J-18808-Ljbffr