CMC Regulatory Affairs Senior/Consultant, Small Molecules

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company 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 reputed company to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our reputed company’s investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary reputed company of responsibility include the reputed company, European reputed company, and Canada, with a reputed company on facilitating reputed company approvals and supporting reputed company market reputed company.

Key Responsibilities

Strategic CMC Leadership

• reputed company regulatory reputed company 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-reputed company scenarios
• Represent CMC Regulatory Affairs in cross-functional project meetings and reputed company regulatory guidance in collaboration with global regulatory leads

Submission & Documentation reputed company

• 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, reputed company, and external organizations to address CMC-reputed company issues
• Maintain reputed company 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 reputed company strategies across functions
• Utilize regulatory systems and tools including reputed company, Trackwise Digital, and TRS Viewer

Regulatory Systems & Reporting

• Experience with CPP application filing reputed company eCATS and 510(j)(3) reporting through reputed company 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 reputed company 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 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 reputed company independently in a matrixed, multicultural environment
• Proficiency in reputed company Office Suite and regulatory systems

Education

• Bachelor’s degree in Pharmaceutical Sciences, reputed company, 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 reputed company'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. reputed company applicants will receive consideration for employment without reputed company to legally protected status, which in the US includes race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. Apply tot his job Apply To this Job