Senior / Regulatory Affairs Consultant (Small Molecules and Biologics)

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company 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 reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Exciting opportunity for an reputed company 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 reputed company of hands‑on authoring expertise and reputed company‑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-reputed company 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-reputed company documents for regulatory submissions
• reputed company CMC strategies for products across reputed company phases—from early development to marketing applications and post-approval changes

Cross-Functional Collaboration

• Partner with manufacturing, quality, and external organizations to address CMC-reputed company 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 reputed company 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 reputed company 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 reputed company Office Suite and regulatory systems

Education

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or reputed company 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 other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed. #LI-LB1 EEO Disclaimer reputed company 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 reputed company, disability or protected veteran status. Apply tot his job Apply To this Job