[Remote] Senior / Regulatory Affairs Consultant (Small Molecules and Biologics)
Note: The job is a remote job and is open to candidates in USA. Parexel is seeking an experienced and highly motivated professional to join their Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role involves ensuring clients’ investigational, new, and marketed small-molecule and biologic products comply with global regulatory requirements while contributing to operational execution and strategic regulatory planning.
Responsibilities
- 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
- 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
- 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
- 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
- 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 Skills
- 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
- 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
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field
- 7+ years of CMC regulatory experience for a Senior Consultant
- Previous experience with combination device products
- Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology
- RAC certification
- Experience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals Company Overview
- Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. It was founded in 1983, and is headquartered in Raleigh, North Carolina, US, with a workforce of 10001+ employees. Its website is Company H1B Sponsorship
- Parexel has a track record of offering H1B sponsorships, with 33 in 2025, 46 in 2024, 41 in 2023, 51 in 2022, 54 in 2021, 33 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply tot his job
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