Senior/Regulatory Affairs Consultant; Molecules and Biologics
Position: Senior / Regulatory Affairs Consultant (Small Molecules and Biologics)
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 next
Gen 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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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 next
Gen 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.
#J-18808-Ljbffr
Apply tot his job
Apply To this Job